Does One Session of Pre-Operative Pelvic Floor Muscle Training Aid In
Nova Southeastern University NSUWorks
Department of Physical Therapy Student Theses, Dissertations and Capstones Department of Physical Therapy
2020
Does One Session of Pre-Operative Pelvic Floor Muscle Training Aid in Improving Urinary Incontinence Immediately Following Robotic Assisted Radical Prostatectomy? A Retrospective and Pilot Study
Francine Noel-Ford Nova Southeastern University
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NSUWorks Citation Francine Noel-Ford. 2020. Does One Session of Pre-Operative Pelvic Floor Muscle Training Aid in Improving Urinary Incontinence Immediately Following Robotic Assisted Radical Prostatectomy? A Retrospective and Pilot Study. Doctoral dissertation. Nova Southeastern University. Retrieved from NSUWorks, College of Health Care Sciences - Physical Therapy Department. (184) https://nsuworks.nova.edu/hpd_pt_stuetd/184.
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DOES ONE SESSION OF PRE-OPERATIVE PELVIC FLOOR MUSCLE TRAINING
AID IN IMPROVING URINARY INCONTINENCE IMMEDIATELY FOLLOWING
ROBOTIC ASSISTED RADICAL PROSTATECTOMY?
A RETROSPECTIVE AND PILOT STUDY
BY
FRANCINE NOEL-FORD, PT, DPT
A dissertation submitted in partial fulfillment of the requirements for the degree of Doctor of Philosophy
Nova Southeastern University Dr. Pallavi Patel College of Health Care Sciences Department of Physical Therapy
2020
Dr. Pallavi Patel College of Health Care Sciences Department of Physical Therapy
We hereby certify that this dissertation, submitted by Francine Noel-Ford, conforms to acceptable standards and is fully adequate in scope and quality to fulfill the dissertation requirement for the degree of Doctor of Philosophy in Physical Therapy.
______Dr. Shari Rone-Adams, PT, MHSA, DBA Date Chairperson of Dissertation Committee
______Dr. M. Samuel Cheng, PT, MS, ScD Date Member, Dissertation Committee
______Dr. Debra Stern, PT, DPT, MSM, DBA Date Member, Dissertation Committee
Approved:
______Dr. M. Samuel Cheng, PT, MS, ScD Date Director, Physical Therapy PhD Program
______Dr. Shari Rone-Adams, PT, MHSA, DBA Date Chair, Department of Physical Therapy
______Dr. Stanley H. Wilson, PT, EdD, CEAS Date Dean and Associate Professor
2020
ii
ABSTRACT
Background: Despite advancements in surgical techniques through the use of robotic assisted radical prostatectomy, urinary incontinence remains the most common side effect following surgery affecting men s quality of life.
Objective: To explore the role of a single pre-operative pelvic floor muscle training session. To determine if men who receive the training session have a decrease incidence of incontinence post-op, whether pelvic floor muscle strength pre-operatively is an independent predictor of urinary incontinence, and the impact of incontinence on quality of life in men following a robotic-assisted radical prostatectomy in the early stages post- operatively.
Design: A two part study with a retrospective portion and a prospective pilot cohort study.
Method: Electronic medical record review of 140 men who have undergone robotic assisted radical prostatectomy was conducted for the retrospective study. For the prospective study, twenty consecutive patients who underwent robotic assisted radical prostatectomy were randomized into 2 groups, the intervention group received the pelvic floor muscle training and the control group did not. Outcome measures included pelvic floor muscle strength, 24 hour pad test, and quality of life instruments.
Results: Urinary incontinence was significantly less at 6 weeks post-op with one session of pre-op pelvic floor muscle training. None of the demographics and PF muscle performance pre-op, with the exception of race, related to incontinence post-op. The pelvic floor muscle training session alone was related to improved continence post-op.
Pelvic floor muscle strength (p = .038) and endurance (p <.001) improved over time and
iii more rapidly in the pelvic floor muscle training group with coinciding diminished severity of incontinence. Functional impact of incontinence decreases over time in both groups with a significantly lesser impact in the PFMT group (IIQ-7, p = .008, UCLA, p
<.001). The impact in the PFMT group at 6 weeks was less than at 3 months in the control group.
Conclusions: The results of this study indicate that a single, pre-operative pelvic floor muscle training session may improve early continence and quality of life outcomes after robotic assisted radical prostatectomy. Larger scale studies should be conducted to corroborate the findings.
iv
ACKNOWLEDGEMENTS
This doctoral dissertation represents the culmination of 9 years of academic and clinical preparation that could not have been achieved without the assistance of many dedicated individuals. First I would like to thank Dr. Joseph Hayes of the Jefferson Surgical clinic for giving me the initial idea of the research project and Dr. Charles Daniel and staff in obtaining approval from their clinic for the data collection procedures and participation of their patients in the study. I would like to thank my dissertation chair Dr. Shari Rone-
Adams of Nova Southeastern University for her acceptance and guidance to the completion of this dissertation. Thank you to the members of the dissertation committee, Dr. Samuel
Cheng and Dr. Debra Stern of Nova Southeastern University and Dr. Ruth Jones and Dr.
Joanne Milios expert physiotherapists for their collaboration in the development and execution of this investigation, as well as Dr. Dane Francis of the Jefferson College of
Health Science for his assistance with the statistics portion of this research. And finally a very special thank you to my husband Jeffrey Ford for his support, patience, understanding, and taking care of our then young four children during this endeavor.
v
TABLE OF CONTENTS
DISSERTATION COMMITTEE APPROVAL AND SIGNATURES ------ii
ABSTRACT ------iii
ACKNOWLEDGEMENTS ------v
TABLE OF CONTENTS ------vi
LIST OF TABLES ------x
LIST OF FIGURES------xi
CHAPTER 1: INTRODUCTION ------1
Overview ------1
Problem Statement and Goal ------2
Relevance and Significance------3
Research Questions ------4
Approach ------4
Operational Definition of Terms------6
Summary ------7
CHAPTER 2: LITERATURE REVIEW ------8
Introduction ------8
The DaVinci Robotic Assisted Prostatectomy ------8
Instrumentation ------8
Outcomes------9
Types of Incontinence------10
Risk Factors of Incontinence ------11
vi
Long Term ------11
Short Term ------12
Pelvic Floor ------14
Anatomy------14
PFMT in Females------16
PFMT in Males post-op------18
PFMT in Males pre-op ------20
PF Strength Assessment ------23
PF Strength as an Outcome Measure ------25
PFMT Protocols------26
Quality of Life ------27
Functional Outcomes ------28
Contribution of the Study------29
Summary------31
CHAPTER 3: METHODOLOGY ------32
Introduction------32
Retrospective Study------32
Research Method ------32
Subjects ------33
Procedure ------34
Data Analysis------35
Prospective Study ------36
Research Method ------36
vii
Subjects ------37
Instrumentation ------38
Procedures ------39
Testing ------40
Intervention ------42
Outcome Measures ------42
Data Analysis ------43
CHAPTER 4: RESULTS ------45
Introduction ------45
Retrospective Study ------46
Participants ------46
Question 1------48
Question 2------50
Prospective Study ------58
Participants ------58
Question 3------60
Question 4------61
CHAPTER 5: DISCUSSION ------69
Introduction------69
Incidence of Urinary Incontinence post-op ------70
Associated Factors ------73
PF Strength/Endurance ------75
Quality of Life ------77
viii
Implications and Recommendations------79
PF Strength and Endurance------79
PFMT Programs------80
Future Research ------80
Limitations and Delimitations------82
Summary ------84
Conclusion------85
APPENDICES------87
Appendix A: Letter of Support------87
Appendix B: Data Collection Form Retrospective Study------88
Appendix C: Informed Consent ------90
Appendix D: Data Collection Form Prospective Study ------94
Appendix E: Hand-outs Anatomy/Physiology ------96
Appendix F: Hand-outs HEP/Bladder Diary ------99
Appendix G: HEP Log ------103
Appendix H: Incontinence Impact Questionnaire ------104
Appendix I : UCLA Prostate Cancer Index ------105
Appendix J: Copyright permissions ------114
REFERENCES------116
ix
LIST OF TABLES
Table 3.1: Variables and Type ------36
Table 3.2: Variables and Type post-op ------44
Table 4.1: Characteristics of Participants retrospective ------47
Table 4.2.a: Comparison of presence of Incontinence at 6 weeks ------48
Table 4.2.b: Comparison of presence of Incontinence at 3 months ------48
Table 4.2.c: Comparison of presence of Incontinence at 12 months------48
Table 4.3.a: Incontinence Factors retrospective at 6 weeks ------55
Table 4.3.b: Incontinence Factors retrospective at 3 months------56
Table 4.3.c: Incontinence Factors retrospective at 12 months------57
Table 4.4: Characteristics of Participants prospective ------59
Table 4.5: Urinary Incontinence as a function of condition and time ------63
x
LIST OF FIGURES
Figure 2.1: Perineum Boundaries------15
Figure 2.2: Pelvic Floor Muscles ------15
Figure 2.3: Male Urogenital System------16
Figure 3.1: Retrospective flow diagram ------35
Figure 3.2: Prospective flow diagram ------40
Figure 4.1: Comparison of incontinence over time ------49
Figure 4.2: Comparison # of pads/day at the 3 points of time ------50
Figure 4.2: Comparison # of pads/day at the 3 points of time (incontinent only)- 50
Figure 4.3: PFM Strength as a Function of Condition and Time ------61
Figure 4.4: PFM Endurance as a Function of Condition and Time------62
Figure 4.5: Pads/day as a Function of Condition at 6 weeks------64
Figure 4.6: Pads/day as a Function of Condition at 3 months ------65
Figure 4.7: IIQ-7 Scores as a Function of Condition and Time ------66
Figure 4.8: UCLA-Function Scores as a Function of Condition and Time - - - - - 67
Figure 4.9: UCLA-Bother Scores as a Function of Condition and Time------68
xi
CHAPTER 1: INTRODUCTION
OVERVIEW
Prostate carcinoma (CA) has been the second leading cause of death in men in America for decades. Since the implementation in 1988 of an annual Prostate-Specific Antigen
(PSA) and Digital Rectal Examination (DRE) screening, more men are being diagnosed with the condition (up to 15%) and are being diagnosed at an early age (average of 66 years old).1,2 The available treatments for prostate CA, include: watchful waiting, cryosurgery, radiation, chemotherapy, hormone therapy, vaccine treatment, bone-directed treatment, and surgery for radical prostatectomy.2 Prostatectomy remains the treatment of choice and may be performed through a number of approaches: traditional open approach, retropubic or perineal, laparoscopic, or more recently, through the da Vinci robotic procedure. The robotic procedure has gained popularity amongst surgeons as the system provides more maneuverability and more precision when moving the instruments than the standard laparoscopic approach and decreased blood loss is associated with the more minimally invasive technique. The extent of the procedures is dictated by the level of the Gleason score and pathology stage of the CA. The risks in all procedures result from the degree of the damage rendered to the surrounding peritoneal fascia, bladder neck, and neurovascular bundle (NVB). The techniques gear to preserve or reconstruct those structures peri-operatively, therefore lower the chances of side effects.3-10 The most common side effects of all procedures are impotence (e.g, erectile dysfunction, changes in orgasm, penis length, loss of fertility) and urinary incontinence (e.g, stress, urge, overflow or continuous). Even with the precision of the robotic assisted prostatectomy, none of the approaches differ in terms of side effects.2,11-17 As many as 87% of men may
1 experience incontinence immediately following prostatectomy1,2,18 and the likelihood of its occurrence increases with age,19-23 thus impacting one s quality of life.
This research explored the role of a pre-operative pelvic floor muscle training (PFMT) session, and whether pelvic floor (PF) muscle strength pre-operatively is a predictor of urinary incontinence and the impact of incontinence on quality of life in men following a robotic-assisted radical prostatectomy in the early stages post-operatively.
PROBLEM STATEMENT AND GOAL
Multiple systematic reviews have concluded to the benefits of PFMT in reducing the incidence of incontinence in females after giving birth and/or following uro- gynecological interventions.24-27 Recently, studies have also shown the same benefits in addressing post-prostatectomy incontinence in men in the short-term28-47 but the long- term benefits have been inconclusive from the results of a number of systematic reviews.48,49 Two studies have correlated PF muscle weakness to the incidence of incontinence following a radical prostatectomy.50,51 The study by Ocampo-Trujillo et al52 shows histologic PF muscle changes with a pre-operative PFMT program. The rationale of PFMT, which focuses on building strength, endurance, speed and coordination of the
PF muscles in various situations, is that it improves PF tone and organ support, thereby reducing the symptoms of incontinence.50 However, only a few studies discuss the benefits of a pre-operative PFMT session in reducing the severity and period of incontinence post-operative53-56while others show no benefit.57,58
Physical therapists who specialize in the treatment of PF muscle dysfunction are positioned in a role of expert clinicians in the assessment of PF strength and the management of urinary incontinence. There are a variety of ways to assess PF strength.
2
The most commonly used tools or techniques used by physical therapists are digital palpation, perineometer, sEMG, the Laycock modified Oxford grading system (0-5 point scale) and the PERFECT scheme.59,60,61
This study explored the effect of receiving a one-time pre-operative PFMT on the occurrence of post-operative urinary incontinence and the impact on quality of life in men following a da Vinci robotic-assisted radical prostatectomy. It was hypothesized that with improved PF awareness and strength, patients who received the PFMT session pre-operatively would not suffer from incontinence to the degree and length of time post- operatively as those patients who did not receive the pre-operative training. The benefits would occur regardless of the pre-operative PF muscle strength, patient s age, Gleason score, T-stage, or NVB preservation
RELEVANCE AND SIGNIFICANCE
There are some conflicting thoughts on the long term benefits of PFMT in the treatment of incontinence for men following a robotic-assisted prostatectomy, as well as in the benefits of pre-operative PFMT in the prevention of post-operative urinary incontinence.
However, there is value if PFMT could aid those patients to improve their quality of life through decreased severity and period of post-operative urinary incontinence immediately following surgery. Improving one s awareness of PF muscles and improving the PF strength prior to prostatectomy could potentially improve organ support and improve the ability to constrict the urinary flow in the urethra during functional activities, thus decreasing the chance of incidence of urinary incontinence.41-44 The improved continence would save on the cost that could result from dealing with incontinence post-operatively, such as having to use pads, prolonged use of physical
3 therapy services post-operatively when the PF muscles have been damaged, and possible need for further more invasive interventions (such as injection of urethral bulking agents, use of clamps, sub-urethral slings, or artificial urinary sphincter implantation).30,62,63
RESEARCH QUESTIONS
Therefore, this research proposed two phases to answer the following questions:
Phase one was a retrospective study:
1. Do men who receive a one-time pre-op PFMT have less incontinence
following the robotic assisted daVinci prostatectomy than men who do not?
2. What are the differences in PF muscle strength and demographic variables
between patients with more vs. fewer incidence of urinary incontinence?
Phase two was a prospective randomized pilot study:
3. Do men who present with the associating factors identified in the retrospective
study have less symptoms of incontinence following the robotic assisted
daVinci prostatectomy vs. those who do not?
4. Do men who have received the one-time pre-op PFMT session present with
improved PF strength, less incontinence, and better quality of life scores in the
early stages following the robotic assisted daVinci prostatectomy compared to
those who did not?
APPROACH
This research consisted of two parts. The first part was a retrospective study. After appropriate Nova Southeastern University IRB approval was received; data was collected from electronic chart reviews of patients who have undergone a da Vinci robotic prostatectomy, with and without completion of a one-time pre-operative PFMT session.
4
Data was retrieved from both the physicians and the physical therapists records taken from their medical history and their respective physical examinations. The pre-operative demographic information was recorded, including: age, ethnicity, level of education, symptoms if any, and stage of prostate CA (Gleason score and clinical T-stage). Intra- operative factors, such as bladder neck and neurovascular bundle preservation were also noted, as well as PF strength and endurance from those patients who have received the one-time pre-operative PFMT by the physical therapist. Post-operative information was collected at 3 points in time: at the post-op follow-up appointments with the surgeon at 6 weeks, 3 months, and one year following the prostatectomy. Post-operative information included incidence and level of urinary incontinence through use and changes of pads/day. Additional information was also gathered, such as other post-operative complications, need of post-operative physical therapy, or whether further intervention was recommended or performed.
The second portion was a small cohort prospective study. Data was collected pre- operatively and post-operatively at 6 weeks and 3 months from a small sample of convenience of 20 patients who had undergone the da Vinci prostatectomy. The subjects were randomly assigned into 2 groups, one received the one-time pre-operative PFMT session and the other did not. Outcome measures included degree of incontinence
(number of pads/day), PF strength (power and endurance), and measures of QoL (IIQ-7 and UCLA-PCI functional questionnaires) (Appendix H-I)
Statistical analysis included descriptive statistics, t-tests and Chi-square tests for demographic comparisons. For the retrospective study, the Chi-square test was used to compare incontinence and the Mann-Whitney test was used to compare the severity of
5 incontinence between the 2 groups at the 3 points of time. Each factor was evaluated using the Chi-square (categorical variables), t-test (normally distributed continuous variables), or Mann-Whitney (non-normally distributed continuous variables) test to assess its association with less incontinence post-operatively in both the retrospective and prospective study. For the cohort study, the variables were further analyzed as a function of time post-op and PFMT condition in a 3X2 mixed-model Analysis of Variance
(ANOVA). For the variables without a pre-op value, a 2X2 mixed-model ANOVA was used.
OPERATIONAL DEFINITION OF TERMS
The following definitions are provided to ensure uniformity and understanding of these terms throughout the study.
Incontinence-involuntary leakage of urine from the bladder.
Intra-operative-occurring, carried out, or encountered during the course of surgery.
PERFECT scheme-Power Endurance Repetitions Fast Every Contraction Timed
grading scale to manually assess the pelvic floor muscle strength and endurance,
using the Oxford scale for the measure of power, number of seconds of
contraction held for endurance, number of repetitions of the contractions.62
Peri-operative-relating to, occurring in, or being the period around the time of a
surgical operation.
Post-operative-relating to, occurring in, or being the period following a surgical
operation.
Pre-operative-occurring, performed, or administered before and usually close to a
6
surgical operation.
Quality of Life- the impact of incontinence on quality of life was measured by 2
condition-specific functional assessment questionnaires: the IIQ-7 and UCLA-
PCI
sEMG-surface electromyography, the electrical activity of individual muscles or
muscle groups is detected and amplified through non-invasive electrodes.
SUMMARY
Prostatectomy remains the treatment of choice to address the presence of prostate CA in men2. Recently the use of the da Vinci robotic-assisted prostatectomy has become increasingly popular with surgeons. Despite the technological advances, there has not been an associated improvement in post-operative complications, with the most common complication being that of urinary incontinence. A PFMT program may aid in the recovery of post-operative continence if performed pre-operatively, before the peritoneal tissues have been damaged. Therefore, this research proposed to identify if a one-time pre-operative PFMT session aids in limiting the severity and duration of post-operative incontinence and its effect on quality of life.
7
CHAPTER 2: LITERATURE REVIEW
INTRODUCTION
Incontinence following a robotic-assisted radical prostatectomy (RARP) remains as one of the most common post-operative complications affecting ones quality of life immediately following surgery.2,12-18 Several factors may influence the occurrence and severity of post-operative incontinence. Being able to predict these factors may aid in the treatment decision making process for both the patient and the surgeon through offering counseling in individualized expected outcomes. Furthermore, identifying the factors that result in increased severity of incontinence post-operatively may allow for earlier intervention such as biofeedback and PFMT that may enhance the likelihood of recovery of continence after the procedure. The following review of selected studies in the field highlights findings most influential in the development of more advanced surgical procedures as well as pre-operative, peri-operative, and post-operative events that may aid in preventing the occurrence of urinary incontinence post-operatively. The review is organized according to historical events, predictors of the occurrence of urinary incontinence post-operatively, and research pertaining to the use of PFMT to address incontinence in men following a prostatectomy.
THE DA VINCI ROBOTIC ASSISTED PROSTATECTOMY
Instrumentation
Laparoscopic surgery for the treatment of prostate CA has been gradually replacing the more commonly used open retro-pubic approach since the 1990s. However, even though this minimally invasive technique results in less morbidity (decreased blood loss and rates of transfusion), the use of the conventional instrumentation remains complex,
8 demanding extensive knowledge in the topographical anatomy and proficiency with endoscopic suturing and intra-corporeal knot tying, which is required in a laparoscopic radical prostatectomy. The advent of the da Vinci RARP in the early year 2000 s in
America provides for a simpler and more enabling endoscopic technique. The daVinci
Surgical System (Intuitive Surgical, Inc., Sunnyvale,CA, USA) incorporates three robotic arms, one holding a novel dual channel endoscope and two holding the endoscopic instruments, which are controlled through manipulation of two master controls mounted on the surgeon s console, where the surgeon sits and operates during the procedure.
Surgeon manipulation of the controls is managed by a processor that filters, scales and relays the exact motion of the surgeon s hands and fingers to the endoscopic instruments.
There is no measurable delay between movement of the surgeon controls and the mirrored movement of the instruments. Tremors and minor insignificant movements of the surgeon that are commonly encountered while holding instruments, particularly during protracted procedures, are eliminated by the processor. The integrated architecture of the instruments and system allow 7 degrees of freedom which is more than allowed by the human hand. The two images of the dual channel endoscope are fused providing the surgeon with a magnified, resolute stereovision image of the operative field. The magnification and manual dexterity offered by the robot allows a higher level of attention to detail and resultant precision in surgery.
Outcomes
It has been suggested that surgical techniques sufficiently refined to preserve or reconstruct the perineal structures peri-operatively would lower the chances of side effects.4-11 Since the advent of the RARP procedure, studies have been conducted to
9 compare the outcomes between the various surgical procedures in an attempt to identify a superior technique. The outcomes measured included those of positive surgical margins and PSA levels as well as physical and mental functioning, urinary continence, potency, and quality of life. All have come to the same conclusion: despite the improved microsurgical precision offered by the RARP to preserve the integrity of the PF structures, the functional and oncological outcomes remain similar between the techniques11-17. However, the RARP does offer the benefits of a minimally invasive technique notably that of decreased blood loss and transfusion rates, decreased post- operative pain, shorter convalescence, and better cosmetics.11,14-17,64-67 Thus, urinary incontinence remains the main post-operative complication affecting men following a daVinci RARP and it has therefore become important to attempt to identify the factors that may influence its occurrence.
Types of incontinence
There are different types of urinary incontinence, including stress, urgency, or mixed.
Stress urinary incontinence refers to the involuntary loss of urine with physical exertion that is the result of anatomical defects in the structures that support the bladder and urethra, while urgency urinary incontinence is associated with the involuntary loss of urine due to a sudden compelling need to void that is due to the contraction of the detrusor muscle, and mixed urinary incontinence presents with signs of both stress and urgency urinary incontinence. The type of urinary incontinence most commonly found in men following a prostatectomy is that of stress urinary incontinence.68,69The degree of incontinence can range from mild to severe, where men experience the loss of urine with
10 changes of positions such as sitting from lying, or standing from sitting, coughing, during physical activities such as lifting or bending, or even at rest.
RISK FACTORS OF INCONTINENCE
Long term
Most studies that have been conducted to identify the factors that predict recovery of continence long-term, have primarily looked at age and surgical procedures. In a large scale study that included functional questionnaires, Shikanov et al70 reported on 1436 patients who underwent RARP and found that younger age (<70) and higher urinary and sexual function pre-surgically were associated with continence at 1 year post-surgically.
A similar analysis by Barnoiv et al19 found in addition that prostate volume, nerve sparing status, and 24 hour urine loss at 1 month post-operatively also predict the risk of urinary incontinence at 1 year with good accuracy. Choi et al4 studied the same factors as well as bladder neck sparing and found that bilateral nerve sparing and bladder neck sparing techniques, and higher urinary function pre-operatively resulted in improved urinary control up to 2 years post-operatively. On a smaller scale, Hakimi et al71 assessed anatomical measurements through endorectal MRI on 75 patients and found that longer urethral length, as well as younger age, lower BMI, higher pre-operative urinary function, and smaller prostate volume correlated to a faster return of continence. Kaye et al6 further assessed the effect of nerve sparing on quality of life and found better outcomes at
12 months with uni- or bilateral nerve sparing, younger age and lower BMI. Conversely, in another large study that assessed the functional outcome of both open procedure and
RARP, Nilsson et al72 did not find that BMI, prostate weight, or comorbidities had an effect on the prevalence of urinary incontinence at a 2 year follow-up. While Novara et
11 al73 agree that no variables related to prostate CA correlated with urinary incontinence in their study, they did find that age and comorbidity index were factors independently predictive of continence recovery at 1 year post-operatively.
Short term
Urinary incontinence usually resolves naturally by the end of the first year following any type of prostatectomy, with individual studies reporting up to 97% continence rate after
RARP.48,49 Therefore, it would seem more advantageous to identify predictors geared at shortening the time to recovery of continence following RARP. Only a small number of studies have been done to examine the factors that may predict recovery within 3 months, especially after RARP. A small study by Potdevin et al8 compared the inter- and intra- facial nerve sparing techniques on functional and oncological outcomes and found that the intra-facial technique improved potency rate and shortened the time to return of continence, however to the detriment of higher rates of positive surgical margins. A much larger study by Srivastava et al74 also found early return of continence with no pad use at 12 weeks when a higher degree of nerve sparing technique was used. In a retrospective study, Kim et al75 identified that age (<70), higher pre-operative sexual health, lower clinical T-stage, lower Gleason score, shorter operative time, lower blood loss, and smaller prostate volume are all associated with urinary recovery within 3 months. However, in a large prospective study on 1299 patients from a high volume center, Ko et al20 demonstrated that only age and nerve sparing were factors for continence by 3 months. Lee et al22 found that only age was associated with early recovery of continence at 6 weeks after adjusting for confounding factors in a multivariate logistic model, but the study was small with limited factors (BMI, IPSS
12 score, nerve sparing). In a large restrospective study spanning over 10 years (from 2003 to 2013), Palisaar et al76 analyzed predictors of short-term recovery of continence at 6 weeks in both the open and RARP. The multivariate results showed that nerve sparing, clinical T-stage, the surgeon s experience, and duration of catheri ation were all independent factors. A recent research conducted by Lavigueur-Blouin et al21 observed pre-operative predictors of pad-free continence recovery at the first follow-up visit one month after RARP and reported a rate of 44% pad-free patients. In their multivariate regression analysis, age and ICIQ (International Consultation on Incontinence
Questionnaire) were the independent predictors of urinary continence at one month.
Other variables, including BMI, PSA, SHIM (Sexual Health Inventory for Men) score, prostate weight, and type of nerve sparing were not statistically significant predictors of very early continence. By contrast, in a large study of more than 1200 patients followed retrospectively, Sammon et al77 concluded that bilateral nerve sparing and the placement of a supra-pubic tube for bladder drainage were predictors of not requiring a pad immediately post-operatively.
Finally, even though some studies seem to contradict each other, a consensus panel78 was conducted in 2012, and following systematic reviews and a meta-analysis, concluded that the following factors that generally contribute to increased risk of post- RARP incontinence are: age, obesity, short membranous urethral length, anastomotic strictures, low surgeon experience, non-nerve sparing techniques, non-bladder neck preservation, and high prostate volume.
All the aforementioned studies have been able to identify patient characteristics and procedural techniques as predicting factors to the incidence of urinary incontinence post-
13 operatively. None have looked at PF strength as a possible factor. One of the aims of this study is to identify whether PF strength is a predictor and whether improved strength results in improved continence immediately post-operatively.
PELVIC FLOOR
Anatomy
A recent research report conducted by Gorniak and Conrad79 has compiled the descriptions in the literature with dissections to re-examine the anatomy and functional interactions of the muscles of the pelvic floor, as well as the endopelvic and visceral support structures. The diamond-shaped perineum is bound anteriorly by the pubic symphysis, posteriorly by the tip of the coccyx, laterally by the pubic arch, ischial tuberosities, and sacrotuberous ligaments, and cranially by the pelvic diaphragm (Figure
2.1). The pelvic diaphragm is part of the pelvic floor musculature and consists of the levator ani (formed by the pubococcygeus and the iliococcygeus) and the coccygeus muscles, and provides support for the pelvic viscera. The superficial and deep transverse perineal muscles, bulbospongiosus, levator prostate, and outer layer of the external anal sphincter attach to the perineal body which is centrally located. The perineum is generally divided into a posterior anal triangle and an anterior urogenital triangle by a line passing through the ischial tuberosities and the perineal body (Figure 2.2). The anal triangle is bordered laterally by the obturator internus muscle and its fascia connecting to the levator ani through the tendinous arch which runs from the pubic body to the ischial spines and is formed by fibers of both muscles. The inferior part of the obturator internus fascia splits to form the pudendal canal through which the pudendal nerve and internal pudendal artery and vein runs through. The urogenital triangle is further divided into the
14 superficial and deep perineal spaces. The superficial transverse perineal, bulbospongiosus, and ischiocavernosus muscles lie in the superficial space, while the deep perineal space consists of the external sphincter urethrae, the compressor urethrae and the deep transverse perineal muscles. The urethra passes through this urogenital diaphragm.
Figure 2.1 Perineum boundaries Figure 2.2 Pelvic floor muscles Reprinted with permission from Elsevier. Copyright 2012
Further providing support to the viscera is the endopelvic fascia that is commonly described as either visceral or parietal fascia. The visceral fascia connects organs to the pelvic wall and to each other as ligaments. It may contain neurovascular bundles embedded in the loose connective tissue. Parietal fascia consists mainly of dense connective tissue associated with the pelvic wall (tendinous arches).
Proper pelvic function requires a balanced interaction between the muscles of the pelvic floor and the supporting connective tissue elements. Maintaining an upward and forward position of the bladder is important for urinary continence. In males, the prostate, urogenital diaphragm, perineal membrane, and bulb of the penis lie stacked like a column caudal to the base of the bladder. This column and the associated ligaments act to
15 mechanically hold the bladder upward (Figure 2.3). Contraction of the levator ani moves the bladder superior and anterior to allow bladder filling. It also elevates the pelvic diaphragm in response to an increase in abdominal pressure. The anterior movement of the bladder changes the angle of the bladder neck to crimp off the urethra thereby preventing flow. Relaxation of the levator ani allows the organs to depress and move posteriorly resulting in urination. Dysfunction of any part of this unit that results in a change in the mobility of the pelvic organs, compromises neurovascular structures, and/or causes postural changes, such as may occur following surgical procedures may increase the chances and severity of urinary incontinence.
Figures 2.3 Male urogenital system Reprinted with permission from Elsevier. Copyright 2012
PFMT in females
While no study has identified PF weakness as a predictor of urinary incontinence in male patients following prostatectomy, extensive research has been conducted on women to demonstrate the effect of a PFMT program in the prevention and treatment of urinary incontinence following childbirth and uro-gynecological procedures. It has become
16 mainstay as a conservative management option since Arnold Kegel documented on the successful treatment of female stress urinary incontinence with the use of pelvic muscle exercises with biofeedback perineometer in 1948.80 Several Cochrane systematic reviews have investigated the benefits of PFMT in improving continence in women, however, the analyses remain inconclusive whether PFMT is better than other therapies (biofeedback, cones, electric stimulation, behavioral), drugs (anticholinergics), or surgeries (slings, colposuspension).26,81,82 A recently updated review by Dumoulin et al83 studied whether
PFMT is an effective treatment in the management of female urinary incontinence compared to no treatment, placebo, sham, or control treatments. The review provided support for the widespread recommendations of PFMT as a first line strategy in the conservative management of urinary incontinence. Compared to the control group women treated with PFMT leaked less frequently and of smaller amount with the benefits persisting up to one year after treatment. In view of these results, Bo et al84 studied the role of PFMT and were able to support a biological rationale verified by ultrasonographic and magnetic resonance imaging. They were able to provide two rationales: firstly that an intentional PF contraction clamps the urethra, thereby increasing the urethral pressure, and secondly that a stronger PF tone provided improved bladder neck support, thereby limiting its downward movement during an increase in intra-abdominal pressure (such as a cough or physical exertion), which in turn prevents urine leakage. Additional studies have shown increased PF strength and tone in continent vs. incontinent women,85-88 and improved PF strength and tone in incontinent women following PFMT with resultant improvements in urinary incontinence.89-96
17
PFMT in males post-op
As a result of the above growing body of evidence pointing to the benefits of PFMT to address urinary incontinence in women, PFMT has also more recently emerged as a conservative treatment option to address male incontinence. Individual studies have found modest benefits of PFMT with or without biofeedback in improving urinary incontinence following radical prostatectomy. One study of 300 men compared early
PFMT without biofeedback initiated prior to discharge to no training.97 The authors found that PFMT significantly reduced the time to recover continence with improvements noted at 1, 3 and 6 months following prostatectomy. Continence was assessed using the
1-hour and 24-hour pad tests and defined as the use of no or one pad per day. At 3 months, continence was achieved in 74% of men in the treated group vs. 30% in the control group. The difference declined at 6 months and by 12 months was no longer significant. Other studies assessed PFMT with biofeedback compared to no training or usual care.47,98,99 A study by Van Kampen et al47 showed the highest success rate. The
PFMT program consisted of individual treatment sessions once a week while the control group received sham treatments. Continence was defined as <2 grams urine loss on a 24- hour pad test. At 3 months after surgery 88% of the men in the PFMT group were continent compared to 56% in the control group. After one year the difference reduced with 95% and 79% of men continent in the treatment group vs. control group respectively. This finding seems to indicate the effect of PFMT decreases over time. It concurs with reviews showing that the urinary symptoms following radical prostatectomy tended to improve over time regardless of conservative management of any type for post- prostatectomy urinary incontinence.36,49
18
Only two studies41,100 investigated and found a physiotherapist guided PFMT to be beneficial in the recovery in continence following prostatectomy when compared to a home written/verbal PFMT program. Other research studies have reported no significant difference between treatments for any outcomes at any of the evaluated times,33,35,101 however, all groups effectively reduced their urine loss after 12 weeks of treatment. The study by Overgard et al102 found no difference between groups at 3 months, but when
PFMT continued up to one year after surgery, the improvements became apparent at the 6 month and 12 month time with 92% continent vs. 72% in the control group by 12 months.
The study suggested that physiotherapist guided PFMT enhanced long term adherence to
PF exercises thereby improving continence rates over time more than information provided to patients for training on their own.
The latest Cochrane Collaboration report conducted by Campbell et al48 on 37 trials cautioned the individual results, stating that the trials were of poor to moderate quality.
They found that the trials were too heterogeneous in variation in the timing, type, and intensity of the PFMT and definition of continence, rendering conclusive and definite evidence difficult. The review included trials in which men also received treatment before surgery and also included trials using biofeedback which were considered together with those without biofeedback. A systematic review by MacDonald et al103 updates the findings of the Cochrane review by focusing solely on PFMT post-prostatectomy. They considered biofeedback enhancement as a separate treatment method. Their analysis found that 57% of subjects receiving PFMT achieved continence or were without continual leakage within two months compared to 37% of control subjects. Within 3-4 months there were no significant differences in rates of continence between the two
19 groups. Furthermore, biofeedback enhanced PFMT was no more effective than oral or written PFMT instructions. Davie et al31 in their review of 14 randomized controlled trials and 7 systematic reviews concurred that the current evidence demonstrates that the recovery time of continence can be shortened with PFMT. Therefore, studies that have looked at the various treatment options in the management of post-prostatectomy urinary incontinence, usually strongly recommend non-invasive therapies such as PFMT (with or without biofeedback and/or electric stimulation) for mild to moderate incontinence in the early months post-operatively, as well as the addition of pharmacological therapy for early success. They further suggest surgical therapies to be considered only if conservative therapy fails, if the incontinence is severe, or if it persists beyond 12 months post-operatively.29,30,63,104
PFMT in males pre-op
Investigators sought to explore whether pre-operative PFMT provided additional benefit in continence recovery in the early stages following prostatectomy. One observational study compared the effects of the pre-operative physiotherapist guided PFMT versus verbal instructions by the surgeon when it was provided at least 4 weeks prior to the surgical intervention.54 The study found that the physiotherapist guided PFMT participants were drier at 6 weeks compared to those receiving instructions by the surgeon, but the effect disappeared by 3 months. Others have shown that there is no advantage of biofeedback over verbal instructions alone when the pre-operative PFMT was initiated 2-4 weeks prior to surgery.57,105,106 A RCT of 180 men conducted by
Geraerts et al107 compared the treatment group who received PFMT weekly for 3 weeks pre-operatively to a control group receiving post-operative PFMT. The PFMT consisted
20 of a 30 min therapist guided program with instructions to perform 60 contractions a day at home. Continence was defined as 3 consecutive days at 0 gr of urine loss on a 24 hour pad test. The results showed that both groups recovered continence to the same extent when assessed at the 1, 3, 6 and 12 month time points. These studies did not find that pre- operative PFMT aided in the recovery of urinary incontinence following prostatectomy as none were able to show better outcomes for the patients who started PFMT pre- operatively compared to those who started post-operatively.
A systematic review conducted by Nahon et al53 found that 9 studies were of good to moderate quality, but found only 4 studies could conclusively attest to decreased time to continence and severity of incontinence when a PFMT program was offered pre- operatively. Other systematic reviews have been able to conclude that a pre-op PFMT program improves early continence as well as QoL, but not long term continence rates.108,109 A small non-randomized study compared several weeks of pre-operative
PFMT with biofeedback to post-operative PFMT and showed faster return of continence in the pre-operative group at 6 weeks post-operatively.55 However, the sample size of 8 subjects per group was too small for the author to draw conclusions with inferential statistics. Parekh et al43 also found early return of continence with pre-operative PFMT, but the difference converged and was no longer statistically significant by 12 months.
The same observation has been noted in other larger randomized control trials.
Centemero et al110 investigated the effect of a PFMT initiated 30 days prior to prostatectomy. Their PFMT program involved a 30-min therapist guided session twice a week. Continence was defined as no leaking as reported in a bladder diary. They found that pre-operative PFMT improved early continence and QoL measures at the 1 and 3
21 month follow-up times with rates of continence at 3 months of 59.3% in the treatment group vs. 37.3% in the control group. Two other studies used bladder diary as the primary outcome for measure of continence, and QoL questionnaires as the secondary outcome. Burgio et al111 found that pre-operative PFMT hastens the recovery of urinary control and diminishes the severity and impact of incontinence when the PFMT was provided in a single biofeedback session 2-4 weeks prior to surgery compared to standard care. In a similar study, Tienforti et al56 arrived to the same conclusion when the pre- operative PFMT session was provided one day prior to surgery. Both studies showed that the decreased incidence, duration, and severity of urinary incontinence lasted until the 6 months follow-up.
Wang et al58 performed a meta-analysis in an attempt to clarify the controversial issue of whether additional pre-operative PFMT would hasten the resolution of urinary incontinence after prostatectomy. They found that only 5 studies were deemed of sufficient quality to qualify for inclusion in their analysis. They found that the studies were able to report higher patient satisfaction and smaller impact of incontinence on QoL in the pre-operative groups. However, the pooled analysis suggested no benefit on continence rates from the additional PFMT pre-operatively at the 1, 3, 6, and 12 month time points. They theorize that the lack of conclusive evidence may be due to heterogeneous pre-operative PFMT regimen (from 4 times to 30 minutes a day) and timing of initiation of the pre-operative PFMT (from one day to 4 weeks pre-surgery) in each study. Furthermore, the discrepancy between the positive and negative studies has been suggested to lie in the choice of the primary outcome in defining continence. The study by Geraert et al107 adhered to a higher standard definition of continence using pad
22 weight. While pad tests are considered to be objective measures, patients may change their activity levels to prevent leakage, thus influencing the results. Most studies that found an advantage to the addition of a pre-operative PFMT defined continence as no urinary leaking reported in a patient completed bladder diary. Possibly incorporating an element of patient perception in the outcome assessment may be more relevant to the clinical scenario. Another factor that may explain the discrepancy is the type of intervention given to the control groups. In the studies with negative findings, control patients received a more intensive regimen of PFMT through written/verbal instructions which is different than standard or no care, and thus may also have impacted the results.
One could speculate that even a low tech pre-operative PFMT can improve the outcomes.
In view of these results further research is needed to elucidate optimal treatment regimen, duration and timing of PFMT pre-operatively, as well as definition of continence in order to obtain maximal urinary recovery.
PF strength assessment
PF muscle strength is most commonly quantified in clinical practice through manual muscle testing or digital palpation using the modified Oxford and PERFECT scales, through use of a perineometer which measures changes in pressure, or through electromyography (EMG) which measures the activity of the muscle. Digital palpation and the use of a perineometer were first described by Kegel80 as methods to evaluate pelvic floor muscle function. In women digital palpation involves placing a finger in the distal vagina and asking the patient to squeeze around the finger and lift inward.
Whereas perineometer consists of a pneumatic device inserted vaginally that measures the pressure in mmHg performed by a pelvic floor muscle contraction. For males the
23 assessment is done via the anal canal. The examination per anum has been found to be a reproducible test of pelvic floor muscle function in men.112 The modified Oxford scale is a 6-point scale where 0 = no discernible PFM contraction; 1 = flicker, or pulsing under the examining finger, a very weak contraction; 2 = a weak contraction, an increase in tension in the muscle without any discernible lift or squeeze; 3 = a moderate contraction characterized by a degree of lifting of the posterior pelvic wall and squeezing on the base of the finger with in-drawing of the perineum; 4 = a good PFM contraction producing elevation of the posterior pelvic wall against resistance and in-drawing of the perineum; 5
= a strong contraction of the PFM; strong resistance can be given against elevation of the posterior pelvic wall.60 PERFECT is an acronym with P = power (the measure of strength), E = endurance (timed maximum contraction held in seconds), R = repetitions,
F = fast contractions, and finally ECT = every contraction timed.61 Both scales have been validated in women and found to have high reliability and reproducibility by the developers.61 A significant correlation was found between muscle strength measured using the Oxford grading scale and lift measured by finger palpation (r = 0.86; p = .03) and muscle strength and perineometric pressure (r = 0.79; p = .001). Interrater reliability for power (r = 0.95; p < .001), endurance (r = 0.95; p < .001), repetitions (r = 0.73; p <
.005), and number of fast contractions (r = 0.91; p < .001) were all good to excellent.
Intrarater reliability was also excellent for power (r = 0.93; p < .001) and endurance (r =
0.99; p < .001). Digital palpation as a measuring tool for pelvic floor muscle strength has also shown high intra-observer rates of reproducibility, but low inter-examiner rates. Bo et al found a Cohen s kappa value of only 0.37 even amongst highly trained physiotherapists.113 These findings were confirmed by several other authors.114-116 By
24 contrast sEMG does not provide a direct measure of strength, but rather measures the electrical activity of the muscle.59 In clinical practice surface electrodes placed over the perineum or vaginally or rectally are most commonly used. Gunnarsson et al117 have shown that PF muscle activity can be measured reliably with sEMG, and Glazer et al118 also found sEMG with strong clinical predictive validity in determining PF related disorders including incontinence. Furthermore, studies have found moderate correlation
(r = 0.63; p < .05) between the digital palpation and sEMG activity.119,120 Bo et al59 concluded that the PF squeeze and lift of a contraction can be most reliably tested with digital palpation, while other measures of muscle function such as endurance and repetition are better tested with sEMG. Both tools can be used to assess different aspects of PF muscle function when assessed by a single examiner. Since a perineometer device was not available to the investigator, digital palpation was used to assess PF strength/power, while sEMG served to determine measurements of endurance (maximum contraction held in seconds and number of repetitions at maximum contraction).
PF strength as an outcome measure
Many studies that have shown an improvement rate in the recovery of urinary incontinence following prostatectomy have also included a measure of PF strength in their outcomes. Rajkowska-Labon et al45 used surface EMG to record the activity of the muscle during a contraction, and found that only the response time, not the amplitude, showed a statistically significant difference in men who received a post-op PFMT program compared to men who did not, possibly indicating improved neuromuscular coordination. Ribeiro et al99 showed an improvement in strength using the Oxford scale while Rigatti et al50 showed an increase in perineometric measures in subjects who had
25 received PFMT. The improved thickness of the PF muscles measured through magnetic resonance imaging by Song et al51 correlated with improved continence at 3 months.
Finally, Ocampo-Trujillo et al52 subjected their participants to an intense pre-operative
PFMT program consisting of supervised PFMT 3 times per day for 4 weeks. They were able to observe changes in the histomorphology of the PF muscles with an increase in the cross-sectional area of the muscle fibers, as well as higher pressures on perineometer, which correlated with improved continence post-operatively.
These findings support the objectives of a PFMT program geared to improve the timing of a PF contraction, strength, endurance, and tone of the PF muscles, thereby increasing urethral pressure and limiting the downward movement of the bladder neck, thus preventing urinary leaking. However, only two studies reporting on pre-operative PFMT included patients with RARP and all studies reporting on the use of PFMT post- operatively were conducted following the traditional open prostatectomy. Only one study compared the use of PFMT post-operatively between the open and RARP. Geraerts et al121 found that the patients who had undergone RARP regained continence sooner and scored significantly better on QoL surveys at 1 and 3 months post-operatively.
PFMT protocols
There are different types of PFMT. The PF muscles consist of 70% type I slow twitch and 30% type II fast twitch muscle fibers, with a general ratio of 2:1.79 The slow twitch fibers can contract for a long period of time at a low force, whereas the fast twitch contract for a shorter time but can generate more force than the slow twitch. The prominence of the slow twitch fibers in the levator ani enable it to support the pelvic viscera and hold the anorectal junction sphincter closed for a long period of time.
26
However, a quick contraction of the PF may be required such as with a sudden increase in abdominal pressure. Therefore, it is important to integrate training to strengthen both types of fibers. Characteristic features of strength training include low numbers of repetitions with high loads which can be achieved by increasing the amount of voluntary effort with each contraction and by performing the exercise first with (lying) then against gravity (sitting, standing). Endurance training is characterized by high number of repetitions or by prolonged contraction with low to moderate loads. Currently there is no standard PFMT protocol. The women s health section of the APTA provides guidelines, which combines the above characteristics. Furthermore, no difference was found whether patients received several health care professional guided sessions54,110 versus one55,56,111 and doing the PF muscles exercises on their own.105 Therefore, this study aimed at providing additional insight in the benefits of a single session of pre-operative PFMT for those patients whose prostate CA was surgically removed through robotic-assisted technology.
Quality of Life
In general most men will experience some level of UI in the first few weeks to months following radical prostatectomy. Urinary incontinence following prostatectomy has been reported by patients to negatively affect their quality of life (QoL).29 The incidence of UI post-prostatectomy varies between 0.8% and 87% in the first 3 to 6 months and between
5% and 87% after one year.36,40,99 The study by Sanda et al122 on QoL showed that UI provided the highest increase level of distress post-op. Studies that have looked at incidence of UI and bother on QoL long term note an impact on men s self-esteem, perception of own health, and impact on their existence, delaying return to work and/or
27 usual physical and social activities at one year post-op123-125 and even onwards to 2 years post-op.126,127 Incontinence has also been found to be associated with feelings of embarrassment, anxiety and fears of not being cured, and reduced confidence.128
In studies that have looked whether post-op PFMT improved QoL scores only two studies53,100 reported that post-op PFMT improved function and incontinence post-op but no difference in QoL parameters compared to their control group was found. However, the many other studies46,51,97,98,99,101,129-131 found a correlation between UI and QoL with noted decreased continence recovery time being associated with lesser impact on men s lives in the post-op PFMT groups. The few studies56,107,108,132 that also included pre-op
PFMT showed men gave a significantly better self-report on QoL up to 6 months post- op. One of the aims of this study was to explore whether a single PFMT session pre-op would aid in improving QoL measures at the early stages post-op.
Functional Outcomes
The impact of urinary incontinence can be assessed through health-related QoL
(HRQOL) patient-reported outcome measures. HRQOL addresses the entire spectrum of human experience, including daily necessities, interpersonal relationships, physical and mental health, illness, and professional and personal happiness. There are a variety of
HRQOL available. The questionnaires chosen for this study are the UCLA-PCI (UCLA-
Prostate Cancer Index) and the IIQ-7 (Incontinence Impact Questionnaire) because they more specifically address the symptom of incontinence. The short forms have been selected because they are more practical in a clinical setting and less burdensome on the patient.
28
The UCLA-PCI is a self-administered, multi-item disease specific instrument developed to capture the health concerns central to the QoL of men treated for prostate CA.133 The questionnaire consists of 3- to 6- point Lickert scales containing 15-disease targeted items that address impairment in the urinary, bowel, and sexual domains. The psychometric properties have been found to be good with test-retest reliability ICC ranging from 0.66 to 0.92 and internal consistency Cronbach ranging from 0.65 to 0.93. It is scored from
0 to 100 with higher scores representing better function and less bothered by incontinence.
The IIQ-7 is a condition specific instrument which was originally designed to assess
HRQOL of middle aged and older women suffering from urinary incontinence.134 Moore et al135 determined that the IIQ-7 can also be used reliably with men. The content validity index was 0.88 and internal consistency ranged between 0.88 and 0.92.
Furthermore, a positive relationship was found between grams of urine loss on a 24 h- pad test and IIQ-7 scores (r = 0.34; p = .003 to r = 0.51; p = .001). The domains include measures of physical activity, social relationships, travel, and emotional health with scores ranging from 0 to 100. When the IIQ-7 scores decreased, self-reported QoL improved.
CONTRIBUTION OF THE STUDY
Urinary incontinence post-operatively is one of the main fears of men who are undergoing a prostatectomy due to its impact on their QoL.29 Health care providers who want to help their patients in dealing with the issues associated with urinary incontinence may be interested in simple techniques which may improve its management. If it is shown that a pre-operative PFMT session aids in reducing the severity of incontinence,
29 more urologists and oncologists may want to refer their patients who will undergo a radical prostatectomy for PFMT. Physicians who may want to refer their clients pre- operatively to prevent post-operative urinary leakage, may seek providers who perform
PFMT within their region. Furthermore, men who choose to undergo a radical prostatectomy are aware of the possible post-operative complication of urinary incontinence and its consequences, and may request pre-operative PFMT in a proactive manner.
Pelvic floor assessment is considered within the scope of practice for physical therapists in all State s Practice Acts.136 However, only a small portion of physical therapists pursue the specialization of pelvic health which includes the assessment and treatment of
PF dysfunction. The few that are, may not all treat men, rendering access to qualified therapists difficult. However, more therapists may want to add PFMT to their services if its benefits are shown, thereby improving the availability of qualified providers.
Therefore, the results of this research may further promote the benefits of a pre-operative
PFMT session in the prevention of post prostatectomy urinary incontinence. If it is indeed shown that a one-time, physical therapist guided PFMT session pre-operatively reduces the severity and duration of post-operative urinary incontinence following a da
Vinci prostatectomy, more men might avoid having to manage the consequences of incontinence, saving them from embarrassment and cost.
Through improved awareness, more therapists may be inclined to pursue this aspect of interventions, and both patients and physicians would seek providers to minimize this post-operative complication. Developed awareness and improved access to the service would enable more men to receive this one-time pre-operative training. This would save
30 on cost induced post-operatively to deal with the consequences of urinary incontinence, and improve men s post-operative quality of life more expediently.
SUMMARY
RARP is becoming the treatment of choice to address prostate CA in men. However, despite the advanced technology, minimal invasive technique, and improved dexterity that allow for limited damage to the perineal structures during surgery, the post-operative complication of urinary incontinence remains unchanged compared to the traditional approaches. Researchers have been able to identify risk factors that may contribute to improved recovery of urinary incontinence post-operatively. However, none of the factors observed in the studies included PF weakness pre-operatively. Improved PF integrity and strength has been shown to improve or reduce the severity and duration of urinary incontinence and its impact on QoL in the early stages when a PFMT was offered post-operatively. It is unclear whether offering pre-operative PFMT has additional benefits. No advantage was found whether the PFMT was performed over a course of several sessions compared to one, or whether the PFMT was supervised compared to done at home. Furthermore, the results of the current literature stem primarily from studies of PFMT and open prostatectomy procedure, while studies of PFMT and RARP are scarce.
Therefore, this study aimed at identifying the possible benefits of a one-time pre- operative PFMT session on patients undergoing a RARP. Whether, the PFMT aids in limiting the severity and duration of post-op urinary incontinence, its effect on QoL, and whether PF strength is a predictor.
31
CHAPTER 3: METHODOLOGY
INTRODUCTION
The first portion of this study was a retrospective analysis with the primary objectives being that of identifying whether men who received the one session of pre-operative
PFMT have symptoms of post-operative urinary incontinence to a lesser degree than those who did not, and whether certain variables such as pre-operative PF strength may predict better outcomes. The second portion of the study consisted of a small prospective cohort study to validate the factors identified in the retrospective study. The rationale for this approach is that the first portion provided a more general picture of the research problem, while the analysis of the second portion refined and explained the results further by exploring individual subjects in more depth.
RETROSPECTIVE STUDY
Research Method
Phase 1 of this study employed a retrospective design to compare adult males who received the pre-operative PFMT and those who did not. Age, BMI, PSA, Gleason score, clinical T-stage, PF strength and endurance, and a post-operative measure of continence recovery defined as the number of pads used were recorded. These were compared between the 2 groups to answer the questions of this research:
- Do men who receive a one-time PFMT have less incontinence following
the robotic assisted daVinci prostatectomy than men who do not?
- What are the differences in PF muscle strength and demographic variables
between patients with more vs. fewer incidence of urinary incontinence?
32
Subjects
Records were collected from the Jefferson Surgical Clinic (letter of support Appendix A) where two physicians routinely perform the da Vinci robotic assisted prostatectomy procedure, as well as from the investigator who is a physical therapist working at Back to
Basics Family Physical Therapy, an outpatient private practice. Both clinics are located in
Roanoke, VA. Dr. Hayes and Dr. Daniel are board-certified urologists with 18 years and
13 years of experience respectively, in the daVinci prostatectomy procedure. They have refined their surgical technique as more evidence-based research has become available through the years. The electronic charts from consecutive patients who have undergone the surgical procedure with and without the pre-operative PFMT session between
1/1/2008 and 12/31/2016 were retrieved by the secretaries from both offices and reviewed by the investigator at the physicians office. To ensure the privacy and confidentiality of patient related data, the investigator employed a sequential numeric coding system that eliminates the ability to identify participants directly from the research records. Access to the computer dataset was password protected and limited to the primary investigator. The investigator was solely responsible for the maintenance of the research records which were secured in a locked cabinet. Records from men between the ages of 50 and 80 years old were included. The records were excluded if there was not sufficient post-operative information on the patients regarding their incontinence status, or if there were intra-operative complications (nerve, rectal, or ureteral injuries, or hemorrhage), or post-operative complications (PE, DVT, MI, wound infection).
Based on the works of Centemero107 et al and Ocampo-Trujillo53 et al, the sample size calculator tool nQuery137 was used to estimate sample size. The results indicated that a
33 minimum sample of 70 subjects per group was needed to achieve 80% statistical power.
Data collection was performed until the minimal number of subjects required per group was reached.
Procedure
Most variables were collected from electronic chart reviews of the patients who have undergone the da Vinci robotic prostatectomy. For those who had also completed a one- time pre-operative PFMT session, data was also retrieved from the physical therapist s records.
The pre-operative demographic information was recorded, including: age, BMI, ethnicity, level of education, symptoms if any, and stage of prostate CA (Gleason score and clinical
T-stage), as well as PF strength (power 1-5/5) and endurance (number of repetitions and seconds hold) from those patients who had received the one-time pre-operative PFMT by the physical therapist. Intra-operative factors, such as bladder neck and neurovascular bundle preservation was also noted. Post-operative information was collected at 3 points in time: at the post-op follow-up appointments with the surgeon at 6 weeks, 3 months, and one year following the prostatectomy (Figure 3.1 flow diagram). Incidence (yes/no) and level of urinary incontinence (number of pads/day) was recorded. Additional information such as other post-operative complications, need of post-operative physical therapy, or whether further intervention was recommended or performed was also gathered (retrospective data collection form Appendix B)
34
Figure 3.1: Retrospective study flow diagram
Data Analysis
Descriptive analyses include central tendency (mean, median) and variability (standard deviation, range, and percentage) were used. The t-test for continuous data and Chi- square test for nominal data was used for comparisons between the two groups.
Furthermore, the Chi-square test was used to compare incontinence and the Mann-
Whitney test was used to compare the severity of incontinence (number of pads/day) between the 2 groups (Table 3.1). Each factor was evaluated using the Chi-square
(categorical variables), t-test (normally distributed continuous variables), or Mann-
Whitney (non-normally distributed continuous variables) test to assess its association with less incontinence post-operatively. Additionally, PFM strength (1-5/5) and
35 endurance (1-10 secs and 1-10 repetitions) were analyzed within the PFMT group to assess whether a weaker PFM is a factor in the severity of post-op incontinence.
The statistical analyses were conducted using the Statistical Package of Social Sciences software (SPSS, version 18.0). The significance level was set at the 0.05 level using a two-tailed test for all hypotheses.
Table 3.1 Variables and type
Age (years) continuous BMI (kg/m²) ordinal Ethnicity categorical (4 categories - White Black Hispanic Other) Level of education categorical (4 levels) Elementary High-school College Post-graduate Symptoms pre-op(Y/N) categorical (2 levels) PSA (ng/ml) continuous Gleason Score(2-10) ordinal Clinical T-stage(I-IV) ordinal (4 levels) PF muscle strength(0-5/5) categorical (3 levels) Poor=0-1, Fair=2-3, Good= 4-5 PF muscle endurance(1-10 continuous, but will be interpreted on a categorical scale secs and 1-10 reps) (3levels) Poor=1-3, Fair=4-6, Good=7- 10 Bladder neck preserved categorical (2 levels) (Y/N) NVB preserved (Y/N) categorical (2 levels)
Post-op UI(Y/N) categorical (2 levels) Severity (#of pads/day) continuous, but will be interpreted on a categorical scale (4 levels) where 0= no UI, 1-2=mild UI, 3-4=moderate UI, 5=severe UI Time intervals 6 weeks 3 months 12 months
PROSPECTIVE STUDY
Research Method
Phase 2 of this study was designed to compare two groups of subjects through a small prospective randomized pilot study. The independent variable is the grouping: a sample of adult males who did not receive the pre-operative PFMT and a sample of adult males
36 who received the pre-operative PFMT. The dependent variables were the measures of PF strength/endurance, severity of incontinence as measured by number of pads used, and the impact of incontinence on the patient s QoL through the condition-specific IIQ-7 and
UCLA-PCI questionnaires. These were compared between the 2 groups at 6 weeks and 3 months post-operatively to answer the following research questions:
- Do men who present with the predictive factors identified in the
retrospective study have less symptoms of incontinence following the
robotic assisted daVinci prostatectomy vs. those who do not?
- Do men who have received the one-time pre-op PFMT session present
with improved PF strength, less incontinence, and better quality of life
scores in the early stages following the robotic assisted daVinci
prostatectomy compared to those who did not?
Subjects
For the prospective study, 20 consecutive patients who were scheduled to undergo RARP in 2017-2018 by Dr. Daniel from the Jefferson Surgical Clinic in Roanoke, VA were recruited. Inclusion criteria were men between the ages of 50 and 80 years old. In order to reduce the risks of any misunderstanding with the instructions given by the researcher, participants were limited to those for whom English is their primary language. Other exclusion criteria included the presence of comorbidities (DM, neurological condition, cognitive impairment, and prior pelvic organ surgeries), sexual dysfunction, and urinary incontinence pre-operatively.
The contact information of every patient who were scheduled to undergo RARP was provided to the secretary of the physical therapy office and the patient was contacted to
37 set-up an appointment, at which time they were also informed that they may be eligible to partake in a research study. Each participant had the choice of being tested at the
Jefferson Surgical Clinic or at Back to Basics Family Physical Therapy clinic in
Roanoke, VA. Potential participants were screened by the physical therapist for exclusion criteria before participating in the study. If at any time during the screening process it became apparent to the researcher that a participant did not meet the selected criteria, the session was abbreviated and that participant s data was not included in data analysis.
All eligible patients provided a signed informed consent prior to the initiation of any data collection and randomi ation. At the time of enrollment, the study s purpose, protocol, potential risks and benefits were explained in detail. Participants were informed that their participation in the study was voluntary, and that they could withdraw at any time. Each participant was provided with a copy of the informed consent form (informed consent
Appendix C).
The randomization schedule was generated by computer using simple random assignment. The surgeon was blinded to intervention assignment. From the participants who met the inclusion criteria and who agreed to participate by signing the informed consent the same pre-operative demographics as described for the retrospective study were collected as well as the PF strength (power 1-5/5) and endurance (# of repetitions and 1-10 seconds hold) measures (data collection form prospective pre-op Appendix F) .
Instrumentation
PF strength and endurance was quantified using the modified Oxford and PERFECT scales. PF strength was graded on a scale from 0/5 to 5/5 via the rectum with digital
38 palpation. Digital palpation to measure PF strength has shown high intra-observer rates of reproducibility, but low inter-examiner rates with a Cohen s kappa value of only
0.37.112 PF endurance was measured by sEMG via a self-adherent electrode (Easytrode
Pregelled Electrodes) placed on the skin nearest the rectum with a dual-channel sEMG device (Pathway Synergy-3D, MR-20, Prometheus Group, Dover, NH). The Pathway
Synergy-3D is a continence evaluation and training system whereby PF function is measured using a pressure sensor. The device is calibrated in accordance with manufacturer directions to assure measurement accuracy. Endurance is calculated as the number of repetitions and seconds of a maximum voluntary contraction of the PF muscles before a reduction in peak force occurs on the recording. The use of sEMG for the measurement of PFM activity has demonstrated good test-retest reliability (r = .86, p<
.001) and clinical predictive validity (p< 0.05).116,117
Procedures
Through random assignment, the 20 participants were separated into 2 groups of 10: one received the pre-operative PFMT session while the other did not receive the pre-operative
PFMT education. An intention to treat at the completion of the study was offered if incontinence persisted. Data was collected 2 weeks pre-operatively, and 6 weeks and 3 months post-operatively (Figure 3.2 flow diagram). The post-operative outcome measures included the aforementioned intra-, and post-operative variables as in the retrospective study, as well as PF strength and endurance, and functional assessment questionnaires (data collection form prospective post-op Appendix D).
39
Figure 3.2: Prospective study flow diagram
Testing:
The physical examination including the assessment of the PF muscle strength and endurance was conducted by the primary investigator. PF strength was assessed through rectal digital palpation. The patient was in the side lying position for ease of access and visualization of the perineum. The therapist inserted her index finger in the anal canal to the levator ani muscles and the patient was asked to contract the PF muscles by squeezing around the finger. The patient was asked to pull the finger up and in, as if to stop the urine flow . He was asked to squeeze the PF muscles as hard as possible for two seconds
40 while the therapist graded the PF strength. A grade between 0 and 5 was given where 0 = no discernible PFM contraction; 1 = flicker, or pulsing under the examining finger, a very weak contraction; 2 = a weak contraction, an increase in tension in the muscle without any discernible lift or squeeze; 3 = a moderate contraction characterized by a degree of lifting of the posterior pelvic wall and squeezing on the base of the finger with in- drawing of the perineum; 4 = a good PFM contraction producing elevation of the posterior pelvic wall against resistance and in-drawing of the perineum; 5 = a strong contraction of the PFM; strong resistance can be given against elevation of the posterior pelvic wall. Observation of a cranial movement of the perineum and scrotum as well as the digital palpation were also used to assure the patient s ability to correctly perform a
PFM contraction without the use of accessory muscles. Next, the PFM endurance was measured with the aid of the sEMG biofeedback. After the skin was prepped with an alcohol pad, the self-adherent electrode was placed on the perineal region between the anus and the scrotum. For the first measure of endurance, the patient was asked to contract the PF muscles as hard as possible and to sustain the contraction for up to 10 seconds. The time when the peak is no longer sustained was recorded. After a 60 seconds rest period, the second measure of endurance was taken. The patient was asked to repeat as many strong contractions as possible by contracting the PF muscles for 2 seconds and resting for 4 seconds up to 10 contractions. The number of the repetition when the maximum peak is no longer reached is recorded. Thereby, PF strength and endurance was quantified using the modified Oxford and PERFECT scales with one grade (0-5) for strength, and two grades for endurance (1-10 seconds sustained contraction, and 1-10 repetitions).
41
Intervention:
The intervention group received an approximately 30 minutes training session from the investigator 2 weeks prior to surgery. Details were provided about the anatomy and physiology of the lower urinary tract and the PF muscles (hand-out Appendix E).
Biofeedback sEMG was used for the PF exercise education portion. Participants performed one set of quick contractions of 2 seconds hold with 4 seconds rest and one set of sustained contractions for 10 seconds with 10 seconds rest for 10 repetitions each.
They received oral and written instructions on PFM contraction and a structured exercise program (hand-outs Appendix F). Participants were asked to perform each set of the quick twitches and the slow twitches four times a day or for a total of 80 squeezes per day to be performed at home while lying, sitting, and/or standing. They were also instructed on behavioral training and the use of a pelvic brace technique which involves the repeated use of a voluntary PF muscle contraction in response to specific situations while carrying out common activities of daily living, such as lifting objects, squatting, or coughing (HEP log Appendix G). Participants started intervention from the day of the training session until the day of surgery and resumed immediately following catheter removal post-operatively until continence was returned.
The non-intervention group did not receive formal education of PFMT. These patients were only given oral instructions from the urologist and from the investigator on PFM anatomy and physiology without recommending a specific exercise regimen.
Outcome Measures
All patients were assessed by the physical therapist at the pre-operative session 2 weeks prior to surgery and at the 6 weeks and 3 months follow-up sessions. All patients
42 completed the self-administered condition-specific questionnaires IIQ-7 (Appendix H) and UCLA-PCI (Appendix I).
The primary outcome measures are degree of incontinence as defined by number of pad use per day (where 0 = return of continence, 1-2 = mild incontinence, 3-4 = moderate incontinence, and >5 = severe incontinence), IIQ-7, and UCLA-PCI scores (where 0 on the IIQ-7 and 100 on the UCLA-PCI indicate return of continence). The secondary outcome measures are that of PF strength (where a grade of 0-1=poor, 2-3=fair, 4-5= good strength) and endurance (where number of repetitions and seconds held 1-3=poor,
4-6=fair, 7-10= good endurance).
Data Analysis
Descriptive analyses including measures of central tendency and variability were used to describe all variables. The t-test for continuous data and Chi-square test for nominal data was used for comparisons between the two groups for the demographics as in the retrospective study (see Table 3.1) with the addition of the functional questionnaires and measures of PF function post-operatively (see Table 3.2). Each factor was evaluated using the Chi-square (categorical variables), t-test (normally distributed continuous variables), or Mann-Whitney (non-normally distributed continuous variables) test to assess its association with less incontinence post-operatively. The variables were further analyzed as a function of time post-op and PFMT condition in a 3X2 mixed-model
Analysis of Variance (ANOVA). For the variables without a pre-op value, a 2X2 mixed- model ANOVA was used.
43
The statistical analyses was conducted using the Statistical Package of Social Sciences software (IBM SPSS, version 18.0, Armonk, NY). The significance level was set at the
0.05 level using a two-tailed test for all hypotheses.
Table 3.2 Variables and type post-op
PF muscle strength(0-5/5) categorical (3 levels) Poor=0-1, Fair=2-3, Good= 4-5 PF muscle endurance(1-10 continuous, but will be interpreted on a categorical secs and 1-10 reps) scale (3levels) Poor=1-3, Fair=4-6, Good=7- 10 Post-op UI(Y/N) categorical (2 levels) Severity (#of pads/day) continuous, but will be interpreted on a categorical scale (4 levels) where 0= no UI, 1-2=mild UI, 3-4=moderate UI, 5=severe UI IIQ-7 (0-100) continuous, but will be interpreted on a categorical scale (4 levels) 0=full continence, 1-33=mild UI, 34-66=moderate UI, 67=severe UI UCLA-PI (0-100) continuous, but will be interpreted on a categorical scale (4 levels) 100=full continence,99-67=mild UI, 66-34=moderate, 33=severe UI Time intervals 6 weeks 3 months
44
CHAPTER 4: RESULTS
INTRODUCTION
The primary aim of this investigation was to identify the possible benefits of a one-time pre-operative PFMT session on patients undergoing a RARP. This study also attempted to explore whether; the PFMT aids in limiting the severity and duration of post-op urinary incontinence, and promoting the QoL. In addition, this research examined whether the pre-operative PF strength can predict urinary incontinence after surgery.
This chapter presents the results of the data analysis and the results corresponding to the specific research questions. The research consisted of a retrospective and a prospective cohort study and thus this chapter is divided into two sections accordingly. The baseline demographics and clinical variables are presented and the comparability of baseline characteristics between the men who received the PFMT and those who did not is examined. The second section addresses the specific research questions for each study.
The research questions for this study were as follows:
1. Do men who receive a one-time pre-op PFMT have less incontinence
following the robotic assisted daVinci prostatectomy than men who do not?
2. What are the differences in PF muscle strength and demographic variables
between patients with more vs. fewer incidence of urinary incontinence?
45
3. Do men who present with the predictive factors identified in the retrospective
study have less symptoms of incontinence following the robotic assisted
daVinci prostatectomy vs. those who do not?
4. Do men who have received the one-time pre-op PFMT session present with
improved PF strength, less incontinence, and better quality of life scores in the
early stages following the robotic assisted daVinci prostatectomy compared to
those who did not?
For the retrospective study, the Chi-square test was used to compare whether or not incontinence is present and the t-test was used to compare the severity of incontinence between the two groups. Logistic regression analysis was used to assess the factors that are predictors of less incontinence post-operatively. For the cohort study, logistic regression analysis was used to assess whether men who presented with the predictive factors have incontinence compared to those who do not. The Mann Whitney U was used to compare the two groups in regards to severity of incontinence, quality of life, and PF strength and Friedman s ANOVA or Wilcoxon Signed Rank was used to examine changes over time
RETROSPECTIVE STUDY
Participants
A total of 393 charts of men between the ages of 51 and 76 years old who had undergone
RARP between 1/1/2008 and 12/31/16 were reviewed for possible study eligibility.
Records were excluded if there was not sufficient information available, or if there were any intra-op or post-op complications. Data collection was performed until the minimal
46 number of subjects (70 in each group) was reached. One hundred and forty men with a mean age of 62.79 (standard deviation, 7.07) years (range, 51-76 years) satisfied the eligibility criteria with 70 men for inclusion in the PFMT group and 70 men in the control group. Descriptive characteristics for the groups are presented in Table 4.1. The mean
(or median), standard deviation (or interquartile range), 95% confidence intervals for the mean (95% CI) and range are provided for age (K-S = .090, p = .008), weight, height (K-
S = .092, p = .005) , BMI, ethnicity, clinical T-stage, Gleason score, PSA, NVB preservation and year of surgery. Comparison revealed no significant differences between the 2 groups for any of the variables.
Table 4.1 Characteristics of participants: retrospective study
47
Question 1: Do men who receive a one-time pre-op PFMT have less incontinence following the robotic assisted daVinci prostatectomy than men who do not?
Chi Square was used to compare the presence of incontinence between the two groups at the 6 weeks, 3 months and 12 months post-op times (Table 4.2, Figure 4.1). The effect was significant for all three time periods; 6 weeks, Fisher s Exact p = .001, (phi) = -
0.286; 3 months, 2 (1) = 42.73, p < .001, (phi) = -0.567; 12months, 2 (1) = 20.47, p
< .0001, (phi) = -0.398. The negative sign of the Phi coefficient indicates that presence of PFMT is associated with absence of incontinence.
Table 4.2.a Comparison of presence of incontinence at 6 weeks
Incontinence Incontinence at 6 weeks No Yes Total PFMT No 1 69 70 Yes 13 57 70 Total 14 126 140
Table 4.2.b Comparison of presence of incontinence at 3 months
Incontinence Incontinence at 3 months No Yes Total PFMT No 9 61 70 Yes 48 22 70 Total 57 83 140
Table 4.2.c Comparison of presence of incontinence at 12 months
48
Incontinence Incontinence at 12 months No Yes Total PFMT No 38 32 70 Yes 63 7 70 Total 101 39 140
Figure 4.1 Comparison in continence over time
Percent Continent over Time per Condition 100 90 80 70 60 50 Control 40 PFMT 30 20 10 0 6 Weeks 3 Months 12 Months
The Mann-Whitney U test was used to compare the severity of incontinence through the number of pads used per day between the two groups. At 6 weeks, the PFMT group
(median = 3.00) used significantly fewer pads per day than the non-PFMT group (median
= 1.00), U = -7.65, p < .001 (see Figure 4.1). At 3 months, the PFMT group (median = 0) also used significantly fewer pads per day than the non-PFMT group median = 2.00), U =
-7.72, p < .001 (see Figure 4.2). Even though both medians were zero, there also was a
49 significant difference in pad use at 12 months, U = -4.94, p < .001; the difference resulted from 7 PFMT patients using only 1 pad per day while the other 63 reported zero pads with only 38 non-PFMT patients reported zero pads while the other 32 reported a range from 1 to 6 pads.
Figure 4.2 Comparison number of pads per day at the 3 time points
Median Number of Pads per Day: All Participants 3.5
3
2.5
2 Control 1.5 PFMT 1
0.5
0 6 Weeks 3 Months 12 Months
Question 2: What are the differences in PF muscle strength and demographic variables between patients with more vs. fewer incidence of urinary incontinence?
Each factor was evaluated using the Chi Square (categorical variables), t-test (normally distributed continuous variables), or Mann-Whitney U (continuous non- normally distributed variables). Data analysis results are presented in Table 4.3
50
Age: There was no significant difference between patients with and without incidence of urinary incontinence at 6 weeks (U = -1.353, p = .176), 3 months (U = -0.357, p = .721), and at 12 months (U = 1.339, p = .181. Age is not related to incidence of incontinence.
Race: Comparisons were done between the white and non-white because there are too few nonwhites to analyze them in separate categories. There was no significant difference between patients with and without incidence of urinary incontinence at 6 weeks (Fisher s
Exact p = .363). Fisher s Exact test was used because at least one cell had an expected value less than five (5), which violates an assumption for Pearson (traditional) Chi
Square. At 3 months there was a significant difference between patients with and without incidence of urinary incontinence ( 2 (1) = 5.218, p = .022). Nonwhites (86.7%) were more likely to be incontinent at 3 months than Whites (59.3%). There was no significant difference between patients with and without incidence of urinary incontinence at 12
2 months ( LR (1) = 0.012, p = .913). Race was related to incontinence, but only at 3 months.
Weight: There was no significant difference between patients with and without incidence of urinary incontinence at 6 weeks (t (138) = 0.464, p = .644), 3 months (t (138) = 0.879, p = .381), and at 12 months (t (138) = -0.220, p = .826). Weight was not related to incidence of incontinence.
Height: There was no significant difference between patients with and without incidence of urinary incontinence at 6 weeks (U = -0.108, p = .914), 3 months (U = 1.391., p =
.164), and at 12 months (U = 1.487, p = .137). Height was not related to incidence of incontinence.
51
BMI: There was no significant difference between patients with and without incidence of urinary incontinence at 6 weeks (U = 0.27, p = .784), 3 months (U = -0.38, p = .703), and at 12 months (U = -0.77p = .444). BMI was not related to incidence of incontinence.
PSA: There was no significant difference between patients with and without incidence of urinary incontinence at 6 weeks (U = -0.003, p = .997), 3 months (U = -0.405, p =. 685), and at 12 months (U = 0.049, p = .961). PSA was not related to incidence of incontinence.
Gleason: There was no significant difference between patients with and without incidence of urinary incontinence at 6 weeks (U = 0.354, p = .723), 3 months (U = -
0.409, p = .683), and at 12 months (U = -0.497, p .619). Gleason score and incidence of incontinence are not related.
Clinical Stage: Clinical stage is being treated as a categorical variable. There was no significant difference between patients with and without incidence of urinary
2 2 incontinence at 6 weeks ( LR (2) = 0.328, p = .849), 3 months ( LR (2) = 2.434, p =
2 .296), and at 12 months ( LR (2) = 0.893, p = .640). Clinical stage and incidence of incontinence are not related.
Symptoms pre-op: There was no significant difference between patients with and without
2 2 incidence of urinary incontinence at 6 weeks ( LR (1) = 0.155, p = .694), 3 months ( LR
2 (1) = 2.887, p = .089), and at 12 months ( LR (1) = 1.590, p = .207). Symptoms pre-op and incidence of incontinence are not related.
PFM Strength: This analysis includes only the 70 patients who received PFM Therapy.
There was no significant difference between patients with and without incidence of
52
2 2 urinary incontinence at 6 weeks ( ML (2) = 0.098, p = .952), 3 months ( ML (2) = 2.390,
2 p = .303), and at 12 months ( ML (2) = 0.430, p = .806). PFM Strength and incidence of incontinence are not related.
PFM Endurance: This analysis includes only the 70 patients who received PFM Therapy.
There was no significant difference between patients with and without incidence of
2 2 urinary incontinence at 6 weeks ( ML (2) = 1.950, p = .377), 3 months ( ML (2) =
2 0.833, p = .659), and at 12 months ( ML (2) = 0.841, p = .657). PFM Endurance and incidence of incontinence are not related.
NVB Status: Because there were only 18 unilateral patients and only 5 no-preservation patients, NVB status was recoded as a dichotomous variable: Bilateral versus Other.
There was no significant difference between patients with and without incidence of urinary incontinence at 6 weeks (Fisher s Exact p = .466), 3 months ( 2 (1) = 2.44, p =
.118), and at 12 months ( 2 (1) = 0.091, p = .763). NVB Status and incidence of incontinence are not related.
PT post-operative: Post-operative physical therapy has a significant but relatively weak
2 relationship with incontinence at 6 weeks, LR (1) = 7.995, p = .005, = .185. Of the incontinent patients, 26.2% received post-op PT, while 0% of the continent patients received PT. At 3 months there was a moderate association between post-operative
2 physical therapy and incontinence, LR (1) = 32.162, p < .001, = .426. Among the incontinent patients 38.6% received PT, while 1.8% of the continent patients received PT at 3 months. The association between post-operative physical therapy and incontinence
2 remain moderate at 12 months, LR (1) = 40.240, p < .001, = .556. Among those who
53 were incontinent, 61.5% received PT, while only 8.9% of the continent patients received
PT at 12 months. Post-operative physical therapy and incidence of incontinence are related at all three time periods.
Intervention (additional surgery post-op): At 6 weeks, there was an association between
2 intervention and incidence of urinary incontinence ( LR (1) = 5.578, p = .018, = .152), however weak. Among incontinent patients, 19.0% received further intervention, while
0% of continent patients received an intervention at 6 weeks. At 3 months, there was a
2 stronger relationship between intervention and incidence of urinary incontinence ( LR
(1) = 28.449, p < .001, = .377). Among those who were incontinent 71.1% received further intervention, while 0.0% of the continent patients received intervention. At 12 months, there was also a strong relationship between intervention and incidence of
2 urinary incontinence ( LR (1) = 64.258, p < .001, = .690). Among incontinent patients,
59.0% received Intervention, while only 1.0% of continent patients received an intervention. Intervention post-op and incidence of incontinence are strongly related and the relationship gets stronger the longer the patient is post-operative.
Of all of the demographic and pre-surgical variables, only race is related to incontinence, and that is only at 3 months. To see if race affects the relationship between PFMT and incontinence, a logistic regression was run on incontinence in which PFMT and race were entered as predictors. For each analysis, race was entered into the prediction first, which statistically controlled for any relationship race might have with incontinence when testing the relationship for PFMT. At 6 weeks, PFMT was a significant predictor (p =
.009), but race was not (p = .998). At 3 months, race was a significant predictor (p =
.016) as expected, but its presence in the prediction equation did not eliminate the PFMT
54
as a predictor (p < .001). At 12 months, race was not a significant predictor (p = .913)
while PFMT was (p < .001).
Table 4.3.a Incontinence factors: retrospective study at 6 weeks
SD 95% Variable Incontinence % Mean Median or Confidence Range p IQR Interval Age No 66.0 7.5 45-73 .176 (years) Yes 63.5 7.3 44-76 Race No 100.0 .067 (% white) Yes 88.1 Weight No 195.2 23.1 181.9-208.6 155-228 .644 (lbs) Yes 198.9 29.1 193.8-204.1 150-306 Height No 5.8 0.25 5.6-6.2 .914 (feet) Yes 5.9 0.33 5.1-6.4 No 27.7 3.24 25.9-29.6 21.6-33.5 BMI .575 Yes 28.3 3.84 27.6-29.0 20.5-40.1 No 5.92 2.33 3.28-8.30 PSA .997 Yes 5.60 3.24 1.55-28.14 Gleason (% No 64.3 .165 Score = 6) Yes 53.2 Clinical No 50.0 Stage (% Yes 43.7 .849 Stage = I) Symptoms No 78.6 .694 (% none) Yes 73.8 PFM No 30.8 Strength Yes 33.3 .952 (% Good) PFM No 7.7 Endurance Yes 14.0 .377 (% Good) NVB Status No 92.9 (% Yes 82.5 .279 preserved)
55
PT post-op No 0.0 .005 (% Yes) Yes 26.2 Intervention No 0.0 post-op Yes 19.0 .018 (% Yes)
Table 4.3.b Incontinence factors: retrospective study at 3 months
SD 95% Variable Incontinence % Mean Median or Confidence Range p IQR Interval Age No 64.0 10.0 44-76 .721 (years) Yes 62.0 8.0 44-76 Race No 96.5 .015 (% white) Yes 84.3 Weight No 196.0 24.4 189.5-202.5 150-250 .381 (lbs) Yes 200.3 30.9 193.6-207.1 150-306 Height No 5.8 0.33 5.4-6.2 .164 (feet) Yes 5.9 0.42 5.1-6.4 No 28.2 3.19 27.3-29.0 21.6-37.0 BMI .796 Yes 28.3 4.15 27.4-29.2 20.5-40.1 No 5.92 3.12 1.72-28.14 PSA .685 Yes 5.60 2.90 1.55-15.10 Gleason (% No 54.4 .363 Score=6) Yes 54.2 Clinical No 50.9 Stage (% Yes 39.8 .396 Stage=I) Symptoms No 66.7 .089 (% none) Yes 79.5 PFM No 29.2 Strength Yes 40.9 .303 (% Good) PFM No 14.6 Endurance Yes 9.1 .659 (% Good) NVB Status No 89.5 (% Yes 79.5 .110 preserved)
56
PT post-op No 1.8 .001 (% Yes) Yes 38.6 Intervention No 0.0 post-op Yes 28.9 .001 (% Yes)
Table 4.3.c Incontinence factors: retrospective study at 12 months
SD 95% Variable Incontinence % Mean Median or Confidence Range p IQR Interval Age No 64.0 8.5 44-76 .181 (years) Yes 65.0 7.0 49-76 Race No 89.1 .913 (% white) Yes 89.7 Weight No 198.9 29.9 192.9-204.8 150-306 .826 (lbs) Yes 197.7 24.6 189.7-205.7 150-240 Height No 5.8 0.33 5.4-6.4 .137 (feet) Yes 5.9 0.42 5.1-6.4 No 28.4 3.88 27.7-29.2 21.6-38.7 BMI Yes 27.9 3.54 26.7-29.0 20.5-40.1 .452 No 5.75 2.95 1.55-28.14 PSA .961 Yes 5.90 3.90 3.60-15.10 Gleason (% No 53.5 .649 Score = 6) Yes 56.4 Clinical No 46.5 Stage (% Yes 38.5 .640 Stage = I) Symptoms No 77.2 .207 (% none) Yes 66.7 PFM No 31.7 Strength Yes 42.9 .806 (% Good) PFM No 12.7 Endurance Yes 14.3 .657 (% Good) NVB Status No 84.2 (% Yes 82.1 .765 preserved)
57
PT post-op No 8.9 .001 (% Yes) Yes 61.5 Intervention No 1.0 .001 (% Yes) Yes 59.0
PROSPECTIVE STUDY
Participants
A total of 49 men between the ages of 53 and 72 years old who underwent RARP
between November 2017 and November 2018 were screened for possible study
eligibility. Men were excluded if their surgery was scheduled less than 2 weeks from the
interview, if there was a language barrier, presence of co-morbidities (DM, neurological
conditions, cognitive impairment, or prior pelvic surgeries), sexual dysfunction, or
urinary leaking pre-op, or if there were post-op complications. Screening was performed
until 20 men who met the inclusion criteria accepted to participate in the study. Of the 29
men who did not participate, 6 declined, 14 had co-morbidities, 1 had urinary leaking
pre-op, 7 had their surgery scheduled within a week of the screening date, and 1 had post-
op complications. The 20 participants chose to be seen at the physical therapy clinic.
They signed the informed consent form and 10 each were randomized in either the PFMT
group or the control group through computer generated simple randomization. Men who
were assigned an odd number were placed in the control group, while those who received
an even number were placed in the intervention group. Data collection was performed 2
weeks prior to surgery and at the 6 weeks and 3 months post-op times. Demographic and
clinical data for the groups are summarized and presented in Table 4.4. The mean (or
58 median), standard deviation (or interquartile range), 95% confidence intervals for the mean (95% CI) and range are provided for age, weight, height, BMI, ethnicity, clinical T- stage, Gleason score, PSA, NVB preservation, PFM strength and endurance, and level of education. All continuous variables were tested for normality using the Kolmogorov-
Smirnov test. Because of small sample sizes all group comparisons were accomplished with Mann-Whitney U or Chi Square. Changes over time (repeated measures) were assessed via Friedman s ANOVA or Wilcoxon Signed Rank. There are no differences between the groups.
Table 4.4 Characteristics of participants: prospective study
59
Question 3: Do men who present with the predictive factors identified in the retrospective study have less symptoms of incontinence following the robotic assisted daVinci prostatectomy vs. those who do not?
As is noted in Table 4.4, there was no demographic differences between the PFMT and control groups. Race was the only demographic variable related to incontinence in the retrospective study and, in this study small numbers required it be reduced to categories of white and non-white.
Chi Square with Fisher s Exact test was used to assess the correlation between race and incontinence. Correlation was not found at 6 weeks (p = .495; with 10 whites and 2 non- whites incontinent, 8 whites and 0 non-whites continent), or at 3 months (p = .479; with 9 whites and 2 non-whites incontinent, 9 whites and 0 non-whites continent).
Question 4: Do men who have received the one-time pre-op PFMT session present with improved PF strength, less incontinence, and better quality of life scores in the early stages following the robotic assisted daVinci prostatectomy compared to those who did not?
60
Variables were analyzed as a function of time and PFMT condition in a 3 (Time: pre-op,
6 weeks, 3 months) X 2 (Condition: PFMT vs. Control) mixed-model Analysis of
Variance; Time is a repeated-measures variable and Condition is a between-subjects variable. For variables without a pre-op value, a 2 (Time) X 2 (Condition) mixed-model
ANOVA was used.
PFM Strength: There is a significant main effect for time, F(2,36) = 4.415, p = .038, partial 2 = .197. PFM Strength increased over time. Neither the main effect for
Condition, F(1, 18) = 0.917, p = .351, partial 2 = .048, nor the Time X Condition interaction, F(2, 36) = 1.358, p = .266, partial 2 = .070, were significant. The PFM strength seemed to increase more in the PFMT group comparing to the control condition
(Figure 4.3) but the difference was not statistically significant.
Figure 4.3 PFM Strength as a Function of Condition and Time
61
PFM Endurance: The results for PFM Endurance display a pattern similar to that for PFM
Strength. There is a significant main effect for Time, F(2,36) = 20.027, p < .001, partial
2 = .527. PFM Endurance increased over time, and the effect size is quite large. Neither the main effect for Condition, F(1, 18) = 0.100, p = .755, partial 2 = .006, nor the Time
X Condition interaction, F(2, 36) = 2.514, p = .095, partial 2 = .123, were significant.
The PFM endurance seemed to increase more in the PFMT group comparing to the control condition (Figure 4.4) but the difference was not statistically significant.
Figure 4.4 PFM Endurance as a Function of Condition and Time
Urinary Incontinence: Changes in the rate of urinary incontinence between conditions were assessed via Fisher s Exact Chi Square separately for occurrences at 6 weeks and at
3 months. As is evident in Table 4.8 below, incontinence was significantly more likely in the Control condition than in the PFMT condition at both 6 weeks and 3 months after the surgery.
62
Table 4.5 Urinary Incontinence as a Function of Condition and Time Condition Time Post-op Incontinence Control PFMT N 0 8 6 Weeks p < .001 Y 10 2 N 1 8 3 Months p < .006 Y 9 2
Pads per Day: Wilcoxon Signed Rank nonparametric test was used to compare number of pads at 6 weeks versus 3 months; there is a significant difference, W = -2.81, p = .005, 6-
Week Median = 1, Interquartile range = 3; 3-Month Median = 0, Interquartile range = 2.
Fewer pads per day were used at 3 months than at 6 weeks. Mann-Whitney U test was intended to be used to test for differences between conditions (PFMT versus Control).
For 6 weeks, it was not possible to conduct an analysis because there was too little variability in the PFMT group. As is evident in Figure 4.8 below, only two participants
(#1 and #12) in the PFMT group reported using any pads at 6 weeks.
63
Figure 4.5 Pads per Day as a Function of Condition at 6 Weeks
The same issue with variability occurred at 3 months post-operative. Only one participant
(#12) in the PFMT conditions was still using a pad at 3 months (Figure 4.6). There was a distribution of pads used in the control condition, with a median value of 1.5 pads per day. Thus, despite the lack of a statistical test, it is obvious that fewer pads per day were used in the PFMT condition than in the control condition.
64
Figure 4.6 Pads per Day as a Function of Condition at 3 Months
IIQ7: IIQ7 scores at 6 Weeks and at 3 Months are normally distributed, so a 2 (Time) X 2
(Condition) ANOVA was used to examine mean differences. Both main effects were significant, but not the interaction. IIQ7 for the PFMT group (M = 20.45, SE = 5.74) was significantly lower, F (1,18) = 8.77, p = .008, partial 2 = .328, than the mean for the control group (M = 45.50, SE = 5.74). Also, IIQ7 at 6 weeks (M = 40.70, SE = 4.74) was significantly higher, F (1, 18) = 15.98, p = .001, partial 2 = .470, than the mean IIQ7 at 3 months (M = 24.25, SE = 4.36). As is evident in Figure 4.7, the advantage for the PFMT was consistent at both times; the interaction was not significant, F(1, 18) = 0.83, p = .374, partial 2 = .044. It is worth noting that the mean score for the control group at 3 months is still higher than the mean score for the PFMT group at 6 weeks.
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Figure 4.7 IIQ-7 Scores as a Function of Condition and Time
UCLA-PCI Function: Scores on the UCLA Function measure are normally distributed, so a 2 (Time) X 2 (Condition) ANOVA was used to examine mean differences. Both main effects were significant, but the interaction was not, F (1,18) = 0.54, p = .470, partial 2 =
.029. Those who received PFMT (M = 69.42, SE = 5.60) scored significantly higher, F
(1,18) = 21.82, p < .001, partial 2 = .548, than those in the control group (M = 32.46, SE
= 5.60). Function score was higher at 3 months (M = 56.61, SE = 4.32) than at 6 weeks
(M = 42.28, SE = 4.33), F (1,18) = 12.01, p = .003, partial 2 = .400. The pattern is displayed in Figure 4.8.
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Figure 4.8 UCLA-PCI Function Scores as a Function of Condition and Time
UCLA-PCI Bother: The UCLA-PCI Bother scores were not normally distributed, K-S6 weeks = .258, p = .001, K-S3 months = .216, p = .016, so Mann-Whitney U tests were performed to test for differences over time as well as differences between groups. In
Figure 4.9 it is apparent that the PFMT group scored significantly higher at 6 weeks (U =
3.10, p = .002), and at 3 months (U = 2.84, p = .005), than the control group. Both groups improved over time, however the change did not yield statistical significance, PFMT W =
1.26, p = .206, and Control W = 1.32, p = .187.
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Figure 4.9 UCLA-PCI Bother Scores as a Function of Condition and Time
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CHAPTER 5: DISCUSSION
INTRODUCTION
The primary purpose of this research was to explore the benefit of receiving a one-time pre-operative PFMT in men following a da Vinci robotic-assisted radical prostatectomy
(RARP). Despite advancing technology and the use of techniques geared to preserve or reconstruct the surrounding peritoneal fascia, bladder neck, and neurovascular bundle
(NVB) the most common side effects remain impotence and urinary incontinence. As many as 87% of men may experience incontinence immediately following prostatectomy1,2,18 thus impacting one s quality of life.
Four specific questions were developed in order to test the relationship between a one- time pre-op PMFT session and urinary incontinence post-op. The first two questions, which were explored through a retrospective study, were on whether the individuals who received the pre-op PFMT had less incontinence than those who did not, as well as identifying factors that are associated with less incidence of urinary incontinence post- operatively. The last two questions, through a prospective cohort study, were on whether the men who presented with the predictive factors identified in the retrospective study had less incontinence than those who did not, and whether men who have received the one-time pre-op PFMT session present with improved PF strength, less incontinence, and better quality of life scores following the robotic assisted daVinci prostatectomy compared to those who did not.
This chapter discusses the findings and compares the results to previous work in the literature, and the contribution of this study to the clinical management of men who will
69 be undergoing RARP. The limitations and recommendations for future research and a summary of conclusions were also provided.
INCIDENCE OF UI POST-OP
Research questions 1 and 4 addressed whether men who received the pre-op PFMT have less incontinence following the RARP than the men who did not. There was a significant difference between the 2 groups at the 3 points in time such that the men who received the pre-op PFMT were more likely to be continent and also to a lesser degree even if they were still incontinent than the men who did not receive the pre-op PFMT, with the strongest effect at 6 weeks in both the retrospective and prospective studies.
The results agree with previous studies43,55,56,110,111 where it was also found that decreased time to continence and severity of incontinence was present when a PMFT program was offered pre-operatively. However, these studies provided one or more pre-op PFMT sessions, as well as post-op PFMT. The current study provided only one pre-op session and no post-op PFMT with the noted improvements. Therefore it results in potential cost saving for the patients and the healthcare system by reducing the total number of visits required. It was not the intent of this study to provide evidence on the ultimate number of visits in order to maximize the effect. The ideal number of visits that can maximize the benefits of PFMT still warrant further investigation.
The result is consistent with studies in which the advantage provided by a PMFT program decreases over time. The results of this study generally show a stronger effect at 6 weeks post-op. Parekh et al43 also found a PFMT advantage for early return of continence at 6 weeks and up to 3 months, but that advantage was no longer significant at 12 months.
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Centemero et al110 investigated the effect of a PFMT initiated 30 days prior to prostatectomy. They found that pre-operative PFMT improved early with the rates of continence of 59.3% at 3 months in the treatment group comparing to only 37.3% in the control group. In the current study, the rate of continence at the same 3 months post-op timeframe were a little higher in the PFMT group (68.6%) but lower in the control group
(12.9%). Two other studies54,55 have shown the most advantages of pre-op PFMT at the early stages of 6 weeks post-op. Patel et al54 conducted a retrospective study on the effect of 4 weeks of pre-op PFMT and also post-op PFMT and concluded the most significant difference occurs at 6 weeks. A study by Sueppel et al, though with only 8 men, also demonstrates the strongest results at 6 weeks post-op with only one session of pre-op PFMT.55
From the data collected for the retrospective study, the single PFMT session was provided between 3 weeks to one day pre-op while the pre-op PFMT session was generally provided 2 weeks pre-op for the prospective study. Studies have shown benefits to pre-op PFMT sessions whether provided as several weekly sessions or as ours as a single session and up to one month pre-op. Burgio et al111 provided a single biofeedback PFMT session 2-4 weeks prior to surgery and in a similar study, Tienforti et al56 provided the PFMT session only one day prior to surgery. Both studies also provided post-op PFMT and found that their pre-operative PFMT hasten the recovery of urinary control, with decreased incidence, duration, and severity of urinary incontinence lasting until the 6 months follow-up.
Conversely, the study by Geraerts et al106 shows no benefit from pre-op PFMT compared to post-op PFMT sessions. They found that both groups recovered continence to the
71 same extent and that there was no difference in the time to continence when assessed at the 1, 3, 6 and 12 month time points. In this retrospective investigation, among those who received pre-op PFMT only 3 men required post-op PFMT and 2 required further surgical interventions vs. 30 men in the control group required post-op PFMT and 23 required surgery. Only one in ten men in the control group of the prospective study required post-op PT once the study was completed. With the similar results as having several post-op sessions, one could argue that one pre-op session has more value, is more cost effective and less bothersome to men undergoing RARP comparing to post-op training.
While studies have found no benefit of biofeedback vs. verbal instructions58,104 or the use of E-stim vs. PMFT alone105, our pre-op PFMT consisted of verbal instructions in combination with biofeedback. This was chosen in order to assure that a correct PF contraction was performed in isolation and also as a means to measure PF endurance.
The men who did not receive the pre-op PFMT session only received verbal instructions from the surgeon or they found information on the internet without specific protocol and guided instruction. One observational study55 compared the effects of the pre-operative physiotherapist guided PFMT versus verbal instructions by the surgeon provided 4 or more weeks prior to the surgical intervention. The study found that at 6 weeks the physiotherapist guided PFMT participants were drier compared to those receiving instructions by the surgeon, but the effect disappeared by 3 months. In this study, additional written instructions regarding exercise regimen and behavioral strategies to prevent leaking during functional activities were also provided by the therapist. This
72 additional education/information may account for the improvements noted compared to
PF exercises alone when provided through written or verbal instructions.
In conclusion, the response to the question whether men who received the pre-op PFMT have less incontinence following RARP than the men who did not is a resounding yes.
The key difference between this study and other studies is that this study showed the benefit of one single session pre-op in reducing the severity of incontinence post-op at the very early stages at 6 weeks post-op.
ASSOCIATED FACTORS
Research questions 2 and 3 addressed whether any factors, such as PF muscle strength and demographic variables, are associated with less incidence of urinary incontinence.
The factors included age, race, height, weight, BMI, PSA, Gleason score, clinical T- stage, symptoms, PF strength, PF endurance, and NVB status.
In our study none of the pre-op demographics were shown to be related to incontinence post-op including PF strength and endurance. Of all the demographics and pre- and peri- surgical variables, only race was related to incontinence in the retrospective study and that only at the 3 months mark. No other studies have looked at race as a predictor of UI post prostatectomy. However, further analysis revealed that its presence did not affect the relationship between PFMT and incontinence.
Two small scale studies7,72 found that lower BMI correlated with a faster return of continence at 12 months post-op. However, other studies support our findings. The study by Novara et al74 found that no variables related to prostate CA correlated with UI post- op. A large study by Nilsson et al73 did not find that BMI had an effect on the prevalence
73 of UI at a 2 year follow-up. Lavigueur-Blouin et al22 also found that BMI and PSA were not statistically significant predictors of very early continence.
All previous studies5,7,20-23,71,72,74,76 that have looked at age as a predictor of risk of UI post-prostatectomy have found that younger age (<70 years old) correlates with faster return of continence. Only 19 patients out of 140 men in the retrospective study were over the age of 70 years old with a median of 62.5 years old for the control group and 65 years old for the PFMT group. Only 2 out of 20 men in the prospective study were over the age of 70 years old with a median of 62 years old for both the control and the PFMT groups. This renders our population in the younger age range and thus may be attributed to the lack of relationship found.
Studies generally agree that a nerve sparing technique is superior to a non-sparing technique and is associated with recovery of continence at one year post-op5,7,20 and as early as 3 months post-op.9,21,75,77,78 The surgeons participating in this study commonly use a nerve sparing technique in which 84% of men received the bilateral nerve sparing and 13% the unilateral nerve sparing technique in the retrospective study. Five out of 20 men in the prospective study received the unilateral nerve sparing technique. The study by Kaye et al7 reported similar recovery with either technique and thus this may also be the reason for lack of relationship in our research as only 5 men underwent a non-sparing procedure in the retrospective study.
A few studies76,77 have also reported on improved continence within 3 months post-op with a lower T-stage and Gleason score. A higher stage or Gleason score of 7 or more indicates a more aggressive CA. Ninety-four percent in the retrospective study and 100%
74 in the prospective study of our population was categorized in the grades I or II T-stages and at a median of 6 on the Gleason score. Most likely early diagnostic screening accounts for the early detection of prostate CA before the CA has had a chance to grow outside the prostate and become more aggressive. Surgical procedures therefore do not need to be as invasive and do not cause as much damage to the surrounding tissues when the CA is better contained and thus possibly accounts for the lack of correlation noted in our research.
In conclusion, this study did not identify any factors, including PF strength and demographic variables that were associated with incidence of urinary incontinence post- op. In such, this study shows that regardless of pre-op variables, it was the PFMT session pre-op that aided in reducing the severity of incontinence post-op.
PF STRENGTH/ENDURANCE
The relationship between PF strength/endurance and incontinence is further explored in questions 3 and 4.
This study used rectal digital palpation and the Oxford scale to grade PF strength and did not show that PF strength pre-op was a predictor of continence post-op. Even men with good strength have some chance of developing urinary incontinence. However, the prospective study shows that there is an inverse relationship between urinary incontinence and PF strength/endurance in that men with good PF strength/endurance are less likely to experience urinary incontinence and those with poor PF strength/endurance are almost certain to have urinary incontinence at both 6 weeks and 3 months post-op.
This relationship between PF strength/endurance and urinary incontinence gets stronger
75 over time. There are a few studies correlate PF muscle weakness to incidence of urinary incontinence following radical prostatectomy, but only one other also notes the relationship getting stronger over time. The pilot study by Rigatti et al51 used perineometric measures pre-op and post-op to assess PF tone and found a significant difference between pre-op pressures in continent vs. incontinent men post-op at 1 and at 3 months when all men received PFMT pre-op and post-op.
Song et al52 used MRI as a means to measure the thickness of the PF muscles and established that continence was related with increased thickness at 3 and 6 months post- op, but PFMT was not provided in their study. The study by Ocampo-Trujillo et al53 shows histologic PF muscle changes through an increase in cross-sectional area of the muscle fibers of the external urethral sphincter which correlated with higher pressures of
PF contraction and improved continence. However, the pre-op PFMT consisted of a 30 days intense training prior to surgery. In this study the one pre-op session occurred less than 3 weeks prior to surgery and thus morphological changes most likely did not occur yet.
The study by Ribiero et al99 also used the Oxford scale to quantify PF strength but examined the effects of early post-op PFMT. They found that improved PF strength hasten the recovery of continence in the PFMT group up to 12 months post-op.
The prospective study we conducted shows that PF strength and endurance improve significantly over time in both groups but more rapidly in the PFMT group, though not statistically significant. Incontinence, however, is significantly more likely in the control group at 6 weeks and 3 months, with noted fewer pads/day used in the PFMT group.
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The lack of significance in this prospective study in regards to improvements in PF strength/endurance may be due to the small sample size, but also because of subjects in our control group were doing some type of Kegel exercises either found on the internet or as recommended by the surgeon. The improvements seen in the severity of incontinence post-op in the PFMT group may therefore align with the rationale originally suggested by
B∅ et al84 that an intentional PF contraction clamps the urethra, thereby increasing the urethral pressure, and that a stronger PF tone provided improved bladder neck support, thereby limiting its downward movement during an increase in intra-abdominal pressure which in turn prevents urine leakage. The men in the PFMT group were taught how to perform a correct and isolated PF contraction with additional instructions in what is commonly called a Knack maneuver. This consists of a pelvic bracing technique to be used during such activities that may be causing an increase in intra-abdominal pressure that may result in a leak, such as while coughing/sneezing, lifting or during changes of position. The study by Rajkowska-Labon et al46 used sEMG to record PF muscle activity and assess post-op improvements in continence through PFMT and found a statistically significant difference in response time, indicating improved neuromuscular coordination.
This could further explain our findings of improved continence in the intervention group.
QUALITY OF LIFE
The effect of pre-op PFMT on the QoL scores was explored in research question 4. The
IIQ-7 and UCLA-PCI urinary domains were used to assess the impact of incontinence on quality of life.
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This prospective study where men received only one pre-op PFMT session found the functional impact of UI to be getting smaller over time in both groups, but with a significant lesser impact on QoL in the PFMT group. Furthermore, the impact at 3 months in the control group was still higher than the impact to the PFMT group at 6 weeks. No other study has previously noted this finding. The measure of the impact of
UI on QoL relies on self-reporting measures. Possibly the men in this study were aware that the measure of the severity of UI was the primary purpose of this investigation and wanted to show good results. A two year follow-up study by Sacco et al18 showed that
QoL is not impacted in men using <1pad/day, but is impacted in men using > 2 pads/day.
In our study, men who received the PFMT session all used 0 or 1 pad/day by 6 weeks and thus may attest for the significantly improved QoL scores at this point in time.
Studies further show that self-esteem and health locus of control influence QoL.138 A recent large-sized prospective trial found that preparedness before surgery for urinary problems decreases the impact of UI up to one year post-op.139 The pre-op PFMT and education in behavioral strategies provided in this study possibly result in reassurance for the patients and improve their confidence that urine can be controlled or stopped in situations where leaking could occur. Therefore helping to overcome the physical, psychosocial, and emotional problems derived from the loss of bladder control in the first few months following surgery.
In conclusion, the functional impact of incontinence gets smaller over time in both groups, but with a significant lesser impact on QoL in the PFMT group. The impact at 3 months in the control group was still higher than the impact to the PFMT group at 6 weeks.
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IMPLICATIONS AND RECOMMENDATIONS
PF Strength and Endurance
The primary finding of this investigation is the strong association between PFMT pre-op and the reduced incidence of UI post-op at all points in time, with the strongest effect being at 6 weeks post-op with only one pre-op PFMT session. Furthermore, PF strength/endurance improved more rapidly in the PFMT group with the resulting impact of UI on QoL less bothersome in the PFMT group. This effect was also strongest at the
6 weeks post-op point. Further larger studies are needed to corroborate the findings of this study and to determine whether 1 session only pre-op is beneficial. However, this preliminary research appears to support the benefits of a pre-op PFMT program. Based on these findings, prophylactic PFMT could be recommended for patients undergoing
RARP and could be part of the guidelines for management of UI as a routine pre-op preparation prior to RARP in urology practice.
Even though the study failed to identify PF strength and endurance as predictors of UI post-op, the relationship between PF strength/endurance and UI post-op was shown to be getting stronger over time. The one-time session of PFMT was provided anywhere between 1 day to 3 weeks pre-op. Possibly initiating PFMT at least four weeks prior to surgery would allow for muscle bulk/tone51,52 and improved strength50,99 to occur prior to surgery, thereby improving urinary control sooner post-op. Recommendations in behavioral strategies should be provided as well, including the use of a pelvic bracing technique during functional activities that may cause UI post-op. This would allow for the practice of this essential skill pre-op when the perineum is still intact. Patients would be able to stop urine flow in situations of an increase in intra-abdominal pressures or with
79 urgency. Giving patients reassurance and improved confidence that urine can be controlled would help overcome the physical, psychosocial, and emotional problems derived from loss of bladder control.
PFMT programs
In most clinical practice a post-op PFMT program would typically be initiated once the severity of UI has been established on follow-up with the surgeon, generally 4-6 weeks post-op. This study shows improvements of UI and less bother from UI by 6 weeks. Of all the patients who received the pre-op PFMT none required post-op PFMT in the prospective study and only 3 out of 70 men in the retrospective study. Most pre-op
PFMT programs including this one consist of 1 to 4 sessions. By contrast there is high variability in terms of duration of programs (3 to 12 months) and number of visits
(ranging between 9 to 48 sessions) in studies that offered post-op PFMT28,39. Therefore, initiating PT interventions pre-op translates to a potential cost saving for patients and the healthcare system by reducing the total number of visits required for successful motor learning to occur.
Future research
Both the retrospective and prospective studies were conducted based on patients coming from one surgical clinic. The data was collected by one physical therapist and therefore the results are biased and not generalizable to the larger population and geography. A study which would include several clinical sites and in various States, provided that there is standardization between surgeons and therapists, would allow for better generalizability.
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Furthermore, this was a pilot study and the sample only included 20 men. A similar study with a larger sample size needs to be conducted to verify the results found in this pilot study. A larger sample size would thereby allow for greater statistical power.
In this study, the pre-op session was performed less than 3 weeks prior to surgery and did not identify PF strength pre-op as a predictor of UI post-op. However, our results did show a relationship between PF strength and UI which was getting stronger over time.
Men who had good PF strength were less likely to experience UI. Therefore, a study where the pre-op session is performed a month prior to surgery may allow sufficient time for improved PF bulk to occur and possibly then render PF strength to have an effect on
UI post-op.
Of all potential associated factors analyzed only race was found to be significant. Non- whites were experiencing more UI than whites, however only at the 3 months post-op time point in the retrospective study. It would be interesting to study a larger sample with non-whites to see whether this was an aberrant finding or not.
Finally, the portion of our study that investigated the impact of UI on QoL noted significantly less impact in the PFMT group at 6 weeks. QoL scores were even better than the control group at 3 months post-op. A study that would look at QoL at 6 weeks post-op comparing men who received a pre-op PFMT to men who received immediate post-op PFMT would further corroborate the importance and advantages of a pre-op session if similar findings were noted.
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LIMITATIONS AND DELIMITATIONS
The primary limitations of this research pertains to its generalizability. The small sample size of the pilot study as discussed previously is a limitation. Also, the research was limited to one clinic and surgical site, thereby limiting the selection of men who underwent RARP to local and primarily white men. In 2018, the census bureau140 notes a population consisting of 60.7% Whites, 13.4% Blacks, 5.8% Asians, and 18.1%
Hispanics. The retrospective study consisted of 89.3% Whites, and only 8.6% Blacks and 2% Hispanics, and the prospective study has 90% Whites and 5% each of Blacks and
Asians, and thus not representative of the general population. Furthermore, delimitations in the prospective study are associated with the inclusion criteria which influence the generalizability of the findings further. The inclusion criteria were chosen to assure a more homogenous group for comparison purposes. However, in this age group it is not uncommon to have co-morbidities and thus this sample is not representative of the general population and findings cannot be generalized.
Another limitation in the retrospective study stems from the nature of such analysis. This type of research does not allow for experimental control over the original data collection process. Demographics and clinical data was extrapolated from the medical records of consecutive men who received RARP between the years of 2008 and 2016. Because of missing data, in order to reach the required sample size, the year of surgery was extended to prior to this therapist s collaboration with the surgeons and thus original data was also gathered by two other therapists. Standardization of protocol between the therapists could not be established. However, these other therapists are known to this investigator
82 and have completed similar training in the assessment of male PF strength. Therefore, data was deemed to be included and supports the validity of the findings.
In the prospective study all the measurements were performed by the same examiner and therefore the examiner was not blinded to group assignment. Also all RARP were performed by the same surgeon. This represents examiner and surgeon bias, however it improved the reliability of the measurements and procedure.
The benefits and results of a PFMT to improve PF strength and improve the symptoms of urinary incontinence are contingent to patient compliance and motivation. The measure of the severity of UI relied on the number of pads used per day, which represents a semi- quantitative and subjective measure. It also relied on functional questionnaires which are self-reporting measures. Men who participated in the prospective study were aware that the measure of severity of UI was the primary purpose of the research and possibly wanted to show good results and thus may affect our findings.
Due to the variability of the definition of continence and measure used in other studies, as well as the lack of a standard protocol for the PFMT session between studies, the results of our study cannot accurately be compared to previous studies.
Finally, the lack of normality and homogeneity of group variances and linearity among the predictors, as well as the small sample size of the prospective study which required the use of non-parametric statistics decrease the statistical power of the analyses.
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SUMMARY
The primary aim of this research was to explore the relationship between receiving a one- time pre-operative PFMT and the occurrence of post-operative urinary incontinence and the impact on quality of life in men following a da Vinci robotic-assisted radical prostatectomy (RARP). Four questions were developed in order to examine this relationship. The first two questions were explored through a retrospective study and included whether the men who received the pre-op PFMT had less incontinence than those who did not, as well as the factors that may be associated with less incidence of urinary incontinence post-op. The next two questions were explored through a cohort prospective study and included whether the men who presented with the predictive factors identified in the retrospective study had less incontinence than those who did not, and whether men who have received the one-time pre-op PFMT session present with improved PF strength, less incontinence, and better quality of life scores immediately following the robotic assisted daVinci prostatectomy compared to those who did not.
The analysis conducted to answer the first question shows a strong association between
PFMT pre-op and decreased incidence of UI post-op at 6 weeks, 3 months and 12 months post-op with the strongest effect being at 6 weeks. Furthermore, the one single session pre-op provided by a physical therapist was sufficient based on the results.
The analysis conducted to answer the second question failed to identify any factors, including PF strength and demographic variables that were associated with less incidence of urinary incontinence post-op except for race at 3 months, in that non-whites were more
84 likely to have UI, however this did not affect the relationship between PFMT and incontinence.
The analysis conducted to answer the third question also showed that none of the demographics pre-op were related to incontinence post-op, but it did show a trend towards a likelihood of not experiencing UI post-op with good PF strength/endurance, less likelihood of UI with fair PF strength/endurance, and almost certain UI with
poor PF strength/endurance at both 6 weeks and 3 months post-op with the relationship between PF strength/endurance and incontinence getting stronger over time.
Finally, the analysis conducted to answer the fourth question show that PF strength and endurance improve significantly over time for all men, however more rapidly in those who have received the pre-op PFMT. Incontinence is significantly more likely in men who did not receive PFMT at 6 weeks and 3 months with the strongest effect at 6 weeks.
The functional impact of incontinence also gets smaller over time in both groups, but with a significant lesser impact on QoL in the PFMT group. The impact at 3 months is higher in the control group than at 6 weeks in the PFMT group.
Conclusion
Therefore, based on the findings of the study and evidence presented this study supports the benefits of a pre-op PFMT program. Prophylactic PFMT could be recommended for all patients undergoing RARP and could be part of the guidelines for management of UI as a routine pre-op preparation prior to RARP in urology practice. Giving men who will be undergoing RARP confidence pre-op that urine can be controlled post-op would help overcome the physical, psychosocial, and emotional problems derived from loss of
85 bladder control. It would further translate to cost savings for the patients and the healthcare system by reducing the total number of PT visits required to achieve continence post-op, by reducing the cost of purchase of incontinence products, and/or by reducing the cost induced by additional surgical intervention.
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APPENDICES Appendix A: Letter of Support
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Appendix B: Data Collection Form Retrospective
Data Collection Form Retrospective Study - Subject # ______- Date of surgery ______- Group Assignment: PFMT Control Excluded Pre-op
Age (years) Hispani Race/Ethnicity White Black Other c High- Post- Elementar Level of Education schoo College graduat y l e
Weight (kg)
Height (m)
BMI (kg/m²
PSA (ng/ml)
Symptoms Yes No
Gleason Score (2-10) Clinical T-stage (I- IV)
PFM Strength (1-5/5) PFM Endurance (1- secs reps 10)
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Intra-op
Bladder neck preserved Yes No
NVB preserved Yes No
Post-op 6 weeks
UI Yes No
Number of pads/day
Post-op 3 months
UI Yes No
Number of pads/day
Post-op 12 months
UI Yes No
Number of pads/day
Other post-op
Complications Yes No
PT Yes No
Intervention Yes No
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Appendix C: Informed Consent
INFORMED CONSENT
Consent Form for Participation in the Research Study entitled: Does one Session of Pre- operative Pelvic Floor Muscle Training aid in improving Urinary Incontinence immediately following Robotic Assisted Radical Prostatectomy: A Retrospective and Pilot Study Primary Investigator: Francine Noel-Ford, PT, DPT, OCS 7768 Williamson Rd Roanoke, VA 24019 (540)985-0500 [email protected] Co- Investigators: Shari Rone-Adams, PT, MHSA, DBA M. Samuel Cheng, PT, MS,ScD 3200 South University Drive 3200 South University Drive Ft. Lauderdale, FL 33328 Ft. Lauderdale, FL 33328 (954) 262-1740 (954)262-1273 [email protected] [email protected]
Data Collection Sites: Back to Basics Family Physical Therapy Jefferson Surgical Clinic 7768 Williamson Rd 1234 Franklin Rd, SW Roanoke, VA 24019 Roanoke, VA 24016 (540)985-0500 (540)283-6000
What is the purpose of this study? You are invited to be in a research study. The purpose of this research study is to determine whether one session of pre-operative pelvic floor muscle training aids in improving the symptoms of urinary incontinence immediately following a robotic assisted radical prostatectomy. We will be comparing the results with men who did not receive the pre-operative session. Research studies are designed to gain scientific knowledge that may help other people in the future. Your participation is voluntary. Please take your time to make your decision, and ask the investigator to explain any words or information that you do not understand. You may also discuss the study with your physician, friends and family.
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Why are you asking me? You are being asked to participate in this study because you are a male who will be undergoing the robotic assisted radical prostatectomy. You will be randomly assigned to either receive the pre-operative training or not receive the pre-operative training session. Men who will not receive the one session training are being asked to participate to be part of a control group so we can compare differences in urinary incontinence following the surgical intervention between the two groups.
What procedures are involved if I agree to be in the study? First, a licensed physical therapist will perform a brief interview to determine if you fit the criterion for inclusion in the study. If you meet the study criteria you will then be asked to fill out a questionnaire. You will be asked to answer questions about your age, occupation, personal health history and some urinary and bladder function specific questions. This part of the study will take approximately 15 minutes. Next, the physical therapist will conduct a physical examination which consists of assessing your pelvic floor muscle strength and endurance. The tests that will be used in this examination are tests which are routinely used by physical therapists in evaluating the pelvic floor muscle. You will be instructed specifically on what you need to do throughout the testing session. You will be placed in the side lying position for ease of access and visualization of the perineum. The strength will be assessed through rectal digital palpation. You will be asked to squee e your pelvic floor muscles around the therapist s finger as hard as you can by pulling the finger up and in. Endurance will be tested through the use of a self- adherent electrode placed on the perineal region between the anus and the scrotum. The electrode is connected to a biofeedback unit which records the activity of the muscle. For the first measure of endurance, you will be asked to contract the pelvic floor muscles as hard as possible and to sustain the contraction for up to 10 seconds. After a 60 seconds rest period, the second measure of endurance will be taken. You will be asked to repeat as many strong contractions as possible by contracting the pelvic floor muscles for 2 seconds and resting for 4 seconds up to 10 contractions. These measures will take approximately 15 min and will allow the therapist to grade your pelvic floor muscle strength and endurance.
What are the potential risks and discomfort? The risk of harm or discomfort that may happen as a result of taking part in this research study is not expected to be more than in daily life or from routine physical or psychological examinations or tests. In healthy adults the risks from performing the anticipated tests are remote. The only foreseeable discomfort would be limited to a muscle soreness following the rectal digital examination. This risk will be reduced by appropriate handling and detailed instructions to ensure that the test is performed correctly. If you have any concerns about the risks or benefits of participating in this study, you can contact Francine Noel-Ford, PT, DPT, OCS, Shari Rone-Adams, PT, MHSA, DBA, M. Samuel Cheng, PT, MS, ScD, or the IRB office at the numbers indicated above.
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Are there any benefits to me for taking part in this research study? You are not expected to receive any direct benefit from taking part in this research study. However, we hope that this research will eventually lead to strategies for preventing the severity of urinary incontinence following prostatectomy and that the information learned from this study will benefit other people in the future.
What are the costs for participating in this research? There are no costs to you if you choose to participate in this research, except for your time.
How will you keep my information confidential and private? Taking part in this research study may involve providing information that you consider confidential or private. Efforts, such as coding research records, keeping research records secure and allowing only the authorized researcher to have access to research records, will be made to keep your information safe. To ensure the privacy and confidentiality of your personal health information, as well as information that directly identifies you, the investigator will employ a sequential numeric coding system that eliminates the ability to identify you directly from the research records. Access to the computer dataset will be password protected and limited to the primary investigator. All data and reports created as a result of your participation in the research study will be entered into the secured computer systems of Back to Basics Family Physical Therapy. These will be kept secure, with access to this information limited to individuals with proper authority. All information obtained from this study will be stored in a locked cabinet in the principle investigators office. All information obtained from this study is strictly confidential unless disclosure is required by law.
Use of Protected Health Information (PHI): As part of this study, you are asked to authorize Francine Noel-Ford, PT, DPT, OCS, Shari Rone-Adams, PT, MHSA, DBA, M. Samuel Cheng, PT, MS, ScD access to your personal health information that is related to this study. Examples of your personal health information include your health history, how you respond to study test procedures, and physical examinations. Your personal health information and information that identifies you will not be given to others during or after the study. The purpose of this authorization is to allow the researcher to obtain the following specific information to be used as part of this research study, to determine the results of the study, to make sure the study is being done correctly and to provide required reports. Any information given would be de- identified.
You may change your mind and revoke (take back) this authorization at any time, except to the extent that the researchers have already acted based on this authorization. To revoke this authorization you must write to: Francine Noel-Ford, PT, DPT, OCS Shari Rone-Adams, PT, MHSA, DBA 7768 Williamson Rd or 3200 South University Drive Roanoke, VA 24019 Ft. Lauderdale, FL 33328
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Refusing to participate or leaving the study will not result in any penalty. If you decide to stop participating in the study there are no potential health or safety consequences. The investigators also have the right to stop your participation in the study at any time. This could be because it is in your best medical interest, your condition worsened, new information becomes available, you had an unexpected reaction, or you failed to follow instructions. If significant new information relating to the study becomes available which may relate to your willingness to continue to participate, this information will be provided to you by the investigators. You have the right to refuse to sign this authorization and informed consent. This will not result in any penalty but you will be unable to participate in the procedures associated with this research study. You have the right to inspect or copy your Protected Health Information to be used or disclosed as permitted under federal and state law (whichever gives you greater access rights). Participating in this study does not affect your rights to inspect or copy your Protected Health Information.
Can I withdraw or be removed from the study? You have the right to refuse to participate or to withdraw at any time, without penalty. If you choose to withdraw, your data will not be destroyed and will be kept for the length of this study plus three years. Your health information that has already been gathered may still be used and disclosed to others. This would be done if it were necessary for the research to be reliable.
Voluntary Consent by Participant: By signing below, you indicate that this study has been explained to you you have read this document or it has been read to you your questions about this research study have been answered you have been told that you may ask the researchers any study related questions in the future or contact them in the event of a research-related injury you have been told that you may ask Institutional Review Board (IRB) personnel questions about your study rights you are entitled to a copy of this form after you have read and signed it you voluntarily agree to participate in the study entitled Does one Session of Pre-operative Pelvic Floor Muscle Training aid in improving Urinary Incontinence immediately following Robotic Assisted Radical Prostatectomy: A Retrospective and Pilot Study.
Participant's Signature: ______Date: ______
Witness's Signature: ______Date: ______
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Appendix D: Data Collection Form Prospective Data Collection Form Prospective Study - Subject # ______- Date to test ______- Date of surgery ______Group Assignment: PFMT Control Excluded Pre-op
Age (years) Hispani Race/Ethnicity White Black Other c High- Post- Elementar Level of Education schoo College graduat y l e
Weight (kg)
Height (m)
BMI (kg/m²
PSA (ng/ml)
Symptoms Yes No
Gleason Score (2-10) Clinical T-stage (I- IV)
PFM Strength (1-5/5) PFM Endurance (1- secs reps 10)
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Intra-op
Bladder neck preserved Yes No
NVB preserved Yes No
Post-op 6 weeks
UI Yes No
Number of pads/day
IIQ-7
UCLA-PI
PFM Strength (1-5/5)
PFM Endurance (1-10) secs reps
Post-op 3 months
UI Yes No
Number of pads/day
IIQ-7
UCLA-PI
PFM Strength (1-5/5)
PFM Endurance (1-10) secs reps
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Appendix E: Hand-outs anatomy/physiology (©2000, Progressive Therapeutics, PC)
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Appendix F: Hand-outs HEP/Bladder Diary (©2000, Progressive Therapeutics, PC)
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Keeping a Record of Bladder Function
The main purpose of a bladder diary is to document how your bladder functions. A diary can give your health care provider an excellent picture of your bladder functions, habits, and patterns. At first, the diary is used as an evaluation tool. Later, it will be used to measure your progress on bladder retraining. Please complete a bladder diary and bring it with you to your appointment. Your diary will be more accurate if you fill it out as you go through the day. It can be very difficult to remember at the end of the day exactly what happened in the morning. Instructions Column 1 Time of Day The log begins with midnight and covers a 24 hour period. Afternoon times are bold. Select the hour block that corresponds with the time of day you are recording.
Column 2 Type and Amount of Fluid and Food Intake Record the type and amount of fluid you drank Record the type and amount of food you ate Record when you woke up for the day and the hour you went to sleep
Column 3 Amount Voided Record the time of day and amount of urine emptied by writing the number of ounces voided, marking S for Small amount, M for Medium amount, L for Large amount, or the number of seconds taken to void.
Column 4 Amount of leakage Record the amount of urine loss at the time it occurred S Small = drop or two of urine M- Medium = wet underwear L- Large = wet outwear or floor
Column 5 Was Urge Present? Describe the urge sensation you had as: 1- MILD = first sensation of need to go 2- MODERATE = stronger sensation or need 3- STRONG = need to get to toilet, move aside!
Column 6 Activity with Leakage/Notes Describe the activity associated with the leakage, i.e., coughed, heard running water, sneezed, bent over, lifted something, or had a strong urge.
Comments Special problems and new or changed medications go here. If a pad change was needed, record the number used during the day at the bottom of the page
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Appendix G: HEP log HOME EXERCISE PROGRAM LOG Please complete log daily Mark on X in each box as you have completed a set of pelvic floor exercises Also mark whether you have completed a pelvic brace and the activity/ies performed
Fast Slow Week # Pelvic Brace Twitches Twitches
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
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Appendix H: IIQ-7 Incontinence Impact Questionnaire, Short Form (IIQ-7)
Incontinence Impact Questionnaire, Short Form (IIQ-7)
Has urine leakage affected your:
Not at Patient Slightly Moderately Greatly all Score 1. Ability to do household chores 0 1 2 3 __ (cooking, housecleaning, laundry)? 2. Physical recreation such as walking, swimming, 0 1 2 3 __ or other exercise? 3. Entertainment activities (movies, 0 1 2 3 __ concerts, etc)? 4. Ability to travel by car or bus more than 30 0 1 2 3 __ minutes from home? 5. Participation in social activities outside your 0 1 2 3 __ home? 6. Emotional health (nervousness, depression, 0 1 2 3 __ etc)? 7. Feeling frustrated? 0 1 2 3 __ TOTAL __
Scoring.The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.
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Appendix I: UCLA-PCI
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Appendix J: Copyright permissions
Dear Francine Noel-Ford
We hereby grant you permission to reprint the material detailed below at no charge in your thesis subject to the following conditions:
1. If any part of the material to be used (for example, figures) has appeared in our publication with credit or acknowledgement to another source, permission must also be sought from that source. If such permission is not obtained then that material may not be included in your publication/copies.
2. Suitable acknowledgment to the source must be made, either as a footnote or in a reference list at the end of your publication, as follows:
This article was published in Publication title, Vol number, Author(s), Title of article, Page Nos, Copyright Elsevier (or appropriate Society name) (Year).
3. Your thesis may be submitted to your institution in either print or electronic form.
4. Reproduction of this material is confined to the purpose for which permission is hereby given.
5. This permission is granted for non-exclusive world English rights only. For other languages please reapply separately for each one required. Permission excludes use in an electronic form other than submission. Should you have a specific electronic project in mind please reapply for permission
6. This includes permission for UMI to supply single copies, on demand, of the complete thesis. Should your thesis be published commercially, please reapply for permission. Yours sincerely
Jennifer Jones Permissions Specialist
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