The Surgical Management of Female Stress Urinary Incontinence Was Extensively Reviewed by Over 50 Physicians Throughout the Country in November 1996

The American Urological Association Female Stress Urinary Incontinence Clinical Guidelines Panel

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Clinical Practice Guidelines Female Stress Urinary Incontinence Clinical Guidelines Panel Members and Consultants

Members Consultants

Gary E. Leach, M.D. H. Roger Hadley, M.D. Claus G. Roehrborn, M.D. (Panel Chairman) Professor and Chairman, (Facilitator/Coordinator) Director, Tower Urology Institute for Urology Department Assistant Professor of Urology Continence Loma Linda University Medical Center Department of Urology Associate Clinical Professor of Urology Loma Linda, California The University of Texas University of California, Los Angeles Southwestern Medical Center Los Angeles, California Karl M. Luber, M.D. Dallas, Texas Director of Section of Urogynecology Roger R. Dmochowski, M.D., Southern California Permanente Hanan S. Bell, PhD (Panel Facilitator) Medical Group (Consultant in Methodology) Associate Professor San Diego, California Seattle, Washington Department of Urology University of Tennessee Medical Center Jacek L. Mostwin, M.D. Patrick M. Florer Memphis, Tennessee Associate Professor (Database Design and Coordination) Brady Urological Institute Dallas, Texas Rodney A. Appell, M.D. Johns Hopkins Hospital Head, Section of Voiding Dysfunction Baltimore, Maryland Curtis Colby and Female Urology (Editor) Department of Urology Pat D. O’Donnell, M.D. Washington, D.C. Cleveland Clinic Foundation Clinical Professor of Urology Cleveland, Ohio University of Arkansas Residents (Data Extraction) Fayetteville, Arkansas Jerry G. Blaivas, M.D. Jeffrey Csiszar, M.D. Clinical Professor of Urology and Jill Gerspach, M.D. Attending Surgeon Steven Kurtz, M.D. New York Hospital/Cornell Medical Center Susan Martins-Levy, M.D. New York, New York Hetal Patel, M.D. Lisa Stout, M.D.

The Female Stress Urinary Incontinence Clinical Guidelines Panel consists of board-certiﬁed urologists and a urogynecologist who are experts in female stress urinary incontinence. This Report on the Surgical Management of Female Stress Urinary Incontinence was extensively reviewed by over 50 physicians throughout the country in November 1996. The Panel ﬁnalized its recommendations for the American Urological Association (AUA) Practice Parameters, Guidelines and Standards Committee, chaired by Joseph W. Segura, MD, in March 1997. The AUA Board of Directors approved these practice guidelines in April 1997. The Summary Report also underwent independent scrutiny by the Editorial Board of the Journal of Urology, was accepted for publication in March 1997, and appeared in its September 1997 issue. A Doctor’s Guide for Patients and Evidence Working Papers have also been developed; both are available from the AUA. The AUA expresses its gratitude for the dedication and leadership demonstrated by the members of the Female Stress Urinary Incontinence Clinical Guidelines Panel in producing this guideline.

ISBN 0-9649702-3-6 Introduction

For women with stress urinary incontinence (SUI)—characterized symptomati- cally by the involuntary loss of urine during activities such as coughing, laughing and positional changes—a number of treatments are available. Patient options include both surgical and nonsurgical therapies. However, a detailed analysis of surgical procedures is missing from previously published clinical practice guidelines such as the one developed by the Agency for Health Care Policy and Research (AHCPR) (Fantl, Newman, Colling, et al., 1996). Guidelines like the AHCPR guideline are directed mainly toward primary care providers and take a broad-based approach covering a range of different types of urinary incontinence in both men and women as well as a wide range of different treatment methods. To provide more detailed information specifically regarding the surgical treatment of SUI in women, the American Urological Association (AUA) convened the Female Stress Urinary Incontinence Clinical Guidelines Panel. The panel conducted a comprehensive review and in-depth analysis of published outcomes data pertaining solely to surgical procedures for treating female stress urinary incontinence. This report is the result of that effort. The focus of the report is relatively narrow. The target patient, termed the index patient, is defined as an otherwise healthy woman with stress urinary incontinence, either untreated or previously treated (surgically or nonsurgically), without significant pelvic organ prolapse, who has decided to seek surgical treatment. The index patient may have either urethral hypermobility or intrinsic sphincteric deficiency or a combination of both. The report provides the following: • A descriptive discussion of incontinence diagnostic procedures (without formal data review and analysis); • Descriptions of surgical procedures for treating SUI; • A summary discussion of the methodology employed by the panel in develop- ing recommendations for choosing a surgical procedure; • Displays of evidence extracted from published outcomes data; and • Recommendations, insofar as the evidence permits, of practice policies for surgical management of SUI in the index patient. As noted above, the panel did not formally review and analyze data on diagnostic procedures since diagnostic evaluation is not the focus of this report; but because a preoperative evaluation is crucial for selection of a treatment option, the panel did make recommendations based on expert opinion regarding the components of a preoperative evaluation. Also included in the report are: (1) discussion of limitations in the literature hin- dering the development of evidence-based recommendations; (2) detailed suggestions for minimal standards to be used in clinical trials for assessing the efficacy of urinary incontinence therapies; and (3) recommendations for future research. A Doctor’s Guide for Patients is available from the AUA upon request. Also available is a technical supplement, Evidence Working Papers.

Introduction ...... i Executive Summary – Report on the surgical management of female stress urinary incontinence ...... 1 Methodology ...... 1 Overview ...... 1 Diagnostic evaluation ...... 1 Nonsurgical therapies for stress incontinence ...... 2 Surgical treatment ...... 2 Treatment outcomes analysis ...... 2 Treatment recommendations ...... 4 Recommendations ...... 6 Research recommendations ...... 7 Chapter 1 – Methodology ...... 8 Literature search ...... 9 Article review and data extraction ...... 9 Data combination ...... 10 Limitations ...... 11 Chapter 2 – Female stress urinary incontinence and its management ...... 13 Overview ...... 13 Diagnostic evaluation ...... 13 Therapy for stress incontinence ...... 15 Chapter 3 – Outcomes analysis: Surgical alternatives for treating female stress urinary incontinence ...... 18 The outcomes tables ...... 18 Analysis of outcomes categories ...... 22 Chapter 4 – Treatment recommendations ...... 26 Overview ...... 26 Flexibility of panel recommendations ...... 26 The index patient ...... 27 Recommendations: Standards ...... 27 Recommendation : Option ...... 28 Chapter 5 – Literature limitations, recommended standards of efficacy for evaluation of treatment outcomes and recommendations for future research . . . .29 Limitations in the literature ...... 29 Standards of efficacy for clinical trials ...... 30 Posttreatment evaluation ...... 31 Research recommendations ...... 31 References ...... 32 Appendix A – Data presentation ...... 40 Appendix B – Comparative outcomes tables ...... 61 Appendix C – Descriptive analysis of urodynamic testing ...... 68 Appendix D – Data extraction form ...... 69 Index ...... 71

SUI may coexist with urgency and/or urge Methodology incontinence. Urgency is characterized by a strong, sudden, uncomfortable need to void. Urge incontinence is characterized by the precipitate loss of To develop recommendations for surgical treat- urine accompanied by urgency. Stress incontinence ment of female stress urinary incontinence (SUI), accompanied by urge incontinence is termed mixed the Female Stress Urinary Incontinence Clinical incontinence. Guidelines Panel reviewed the SUI surgical treatment literature to January 1994 and extracted and An estimated 30-65 percent of women with SUI meta-analyzed all relevant data to estimate as accu- present with mixed incontinence (McGuire and rately as possible both desirable and undesirable Savastano, 1985). The components vary in their outcomes of the various surgical procedures. The contribution to the presenting symptom complex. panel followed an explicit approach to the develop- In some cases, urgency or urge-related incontinence ment of practice policy recommendations (Eddy, may be the predominant symptom. When urgency 1992). This approach emphasizes the use of scien- and/or urge incontinence is a symptom, coexistent tiﬁc evidence in estimating outcomes. If the evi- infection, bladder stones, cancer, obstruction and dence has limitations, the limitations are clearly neurologic disease are excluded during the diag- stated. When panel opinion is necessary, the expli- nostic evaluation. cit approach calls for an explanation of why it is necessary and/or discussion of the factors considered. For a full description of the methodology, see Chapter 1. Diagnostic evaluation

Essential to the management of SUI is an accu- Overview rate diagnosis. The diagnostic evaluation includes a thorough history and physical examination supplemented by urinalysis and other appropriate labora- This Report on the Surgical Management of tory studies. Female Stress Urinary Incontinence focuses on surgical treatment of stress urinary incontinence in the There are two basic factors to be evaluated: ure- otherwise healthy female. The panel did not con- thral hypermobility and/or intrinsic sphincteric sider for analysis either incontinence associated deficiency (ISD). The two may coexist. with neurologic disease or incontinence associated Hypermobility, present in the majority of women with significant pelvic organ prolapse (large cysto- with SUI, is the rotational descent of the proximal cele, enterocele, rectocele, uterine or vault pro- urethra and bladder neck into the vagina, associated lapse). with increases in abdominal pressure that occur SUI is the involuntary loss of urine related to with such activities as coughing. Hypermobility increases in abdominal pressure resulting from can be observed visually or radiographically. Its activities such as coughing, laughing, lifting and presence, however, does not necessarily indicate positional changes. Spontaneous urinary inconti- SUI; many women have urethral hypermobility nence may also occur when a woman is either without SUI. If incontinence does occur, an ele- seated or standing. Gravitational loss of urine (loss ment of sphincteric weakness is present. of urine with postural change) occurs in the most The second factor, ISD, also represents a signifi- severe cases. cant component of incontinence in women. The prevalence of ISD is not fully known, but in the

Copyright © 1997 American Urological Association, Inc. Executive Summary Page 1 panel’s expert opinion it is present in a significant The goal of surgery for ISD is recreation of ure- percentage of women with stress incontinence. ISD thral coaptation, either by external bolstering (sling refers to a deficiency in the urethral sphincter func- or artificial sphincter) or by internal bulking tion, which is unrelated to urethral support. The (injectable agents). most common reasons for loss of this urethral func- All four of the major procedure categories tion are prior incontinence surgery, prior pelvic reviewed—retropubic suspensions, transvaginal surgery (radical hysterectomy, abdominoperineal suspensions, anterior repairs and sling proce- resection of rectum), neurologic disorders (spina dures—may be considered for demonstrable proxi- bifida), urethral mucosal atrophy and, in rare cases, mal urethral hypermobility in the presence of intact radiation exposure. The result is poor urethral sphincteric function. However, when sphincteric mucosal coaptation and incontinence with minimal function is poor, a procedure such as a sling, an stress activities. injectable agent or an artificial urinary sphincter The selection of a surgical procedure should should be considered. Pubovaginal slings are also reflect the relative contributions of these two condi- an option in those patients with SUI due to com- tions, which as noted previously may coexist. bined hypermobility and poor urethral coaptation.

Nonsurgical therapies Treatment outcomes for stress incontinence analysis

Management of SUI includes the option of non- The comparative outcomes tables on pages 19 surgical therapies. Chief among them are behav- and 20 (Tables 1 and 2) display probability esti- ioral management techniques such as timed void- mates for the four major procedure categories: ing, pelvic floor exercises, biofeedback, insert retropubic suspensions, transvaginal suspensions, devices, functional electrical stimulation and phar- anterior repairs and pubovaginal sling procedures. macologic therapy. The panel did not review non- All outcome probability estimates were developed surgical therapies because they are outside the by combining outcomes data for the various indi- scope of this report. vidual procedures that make up each of the four major procedure categories. For example, in the first cell of Table 1, under the “Retropubic Suspen- sions” heading, the median probability estimate for Surgical treatment cure/dry at 12-23 months is 84 percent. This estimate was derived from combined cure/dry data for Surgical approaches to SUI are diverse. Grouped Burch, Marshall-Marchetti-Krantz and various within four major categories of procedures are other individual retropubic suspension procedures. many individual procedures and modifications of The other probability estimates in the “Retropubic procedures. The four major groupings are retropu- Suspensions” column, including estimates of poten- bic suspensions, transvaginal suspensions, anterior tial complications, were also derived from com- repairs and sling procedures. Insufficient data pre- bined outcomes data for the various individual pro- cluded panel analysis of artificial sphincters and cedures that make up the retropubic suspension injectable agents. grouping. Similarly, the estimates in the “Trans- Historically, surgical procedures to treat SUI vaginal Suspensions” column were derived from were designed to elevate/suspend and reposition combined outcomes data for Pereyra/modified the urethra. The current goal, in the panel’s opin- Pereyra, Stamey, Gittes and other types of individ- ion, is to stabilize the proximal urethra and bladder ual transvaginal suspension procedures. The panel neck (i.e., prevent their descent). Suspension proce- found no significant differences between individual dures and pubovaginal slings may be used for procedures within each of the four major categor- demonstrable proximal urethral hypermobility in ies. the presence of intact sphincteric function. After analyzing cure/dry data variously reported in the literature at time points 12-120 months, the panel defined the three discrete time frames in

Page 2 Executive Summary Copyright © 1997 American Urological Association, Inc. Table 1: 12-23 months follow-up (short term), 24- For these reports, the panel inferred an “improved” 47 months follow-up (intermediate) and follow-up rate of 0 percent. of 48 months and longer (long term). Probability estimates for treatment complications The rates indicate that after 48 months, retropu- are displayed in Tables 1 and 2 beginning with esti- bic suspensions and slings appear to be more effi- mates of postoperative urgency, which are dis- cacious than transvaginal suspensions and anterior played in Table 1 relative to patients’ preoperative repairs. For anterior repairs, however, the rates status. Analysis of the four patient subgroups listed after 24 months are anomalous—with a sharp under the “Postoperative Urgency” heading reveal- increase in cure/dry status at 24-47 months (from ed no major statistical differences between trans- 68% to 85%), then a sharp decline after 48 months vaginal suspensions, sling procedures and retropu- (to 61%). These rates are believed by the panel to bic suspensions with regard to postoperative represent an aberrancy of data reporting rather than urgency. Insufficient data exist to evaluate anterior true outcomes. Such results occur because not all repairs for this outcome. In general, if urgency and studies report outcomes at all time points. DI are present preoperatively, there is significant For ISD therapy, cure/dry results are incom- risk of these symptoms persisting postoperatively. pletely reported in the literature because recogni- If either is absent, the risk of postoperative urgency tion of ISD as a diagnostic entity is relatively new. is reduced. However, no accurate statistical state- In the panel’s opinion, sling procedures are the ments can be made regarding these tendencies most effective type of treatment for ISD patients. because of small total sample sizes. However, the available data are insufficient to The panel determined that two time periods determine whether other types of procedures might should be reported for urinary retention: (1) reten- be equally effective. tion greater than four weeks and (2) permanent The panel also attempted to determine from the retention. For temporary retention, the panel recog- literature the degree to which factors such as nized that the data for less than four weeks reflect patient age and prior surgery have an impact on varying practice patterns and changes in hospital- cure/dry outcomes. Factors the panel evaluated ization practices and medical management over the include the following: prior incontinence surgery, time frame of the literature reviewed. The data can- subjective urgency, urodynamically proven detrusor not be meaningfully combined because of differing instability (DI), menopausal status, parity, prior lengths of hospital stay and different studies mea- hysterectomy and age. Because of incomplete data suring retention at different points in time. and varying definitions within the data, the panel The estimated probability of temporary urinary could make no determinations regarding the effects retention lasting longer than four weeks is 5 per- of these variables on cure/dry rates. cent for both retropubic and transvaginal suspen- Cure/dry rates alone do not fully represent all sions and 8 percent for sling procedures. For ante- potential treatment benefits. Many patients, even if rior repairs, the retention data were insufficient to not completely cured of their SUI problem, report generate a probability estimate. very substantial improvement and consider the For permanent retention, there are no accurate surgery successful. For this reason, the panel data to date. In the panel’s opinion, the risk is included a “Cure/Dry/Improved” category in Table somewhat higher for sling procedures than for 1 (cure/dry plus improved). As would be expected, other procedures. However, for all procedures, cure/dry/improved rates are higher than cure/dry panel opinion is that the risk of permanent reten- rates alone for all treatment types across all three tion generally does not exceed 5 percent. time frames. Both cure/dry rates and cure/dry/im- Days in the hospital, as reported in the literature, proved rates are displayed graphically on page 21 again reflect practice patterns that in the panel’s as well as in Table 1 on page 19. opinion are no longer current. Assuming an uncom- Cure/dry/improved data are variously reported in plicated stay, based on current practice, the panel the literature. Some reports clearly specify an determined that length of hospital stay for each “improved” rate as well as a “cure/dry” rate. Other treatment type ranges from 0 to 5 days, with the reports do not specify a “cure/dry” rate, but classify shortest length of stay for transvaginal suspensions patients as “cured/improved,” “improved” or and anterior repairs. “failed.” Still other reports omit “improved” and The panel attempted to analyze obstruction diag- classify patients as either “cure/dry” or “failed.” nosed by urodynamics and pelvic prolapse as well

Copyright © 1997 American Urological Association, Inc. Executive Summary Page 3 as urinary retention and other possible complications of surgery. However, the obstruction data Treatment recommendations were variable and incomplete, with differing definitions and a lack of objective data. The panel generated treatment recommendations Also, there was insufficient information to esti- based on outcomes estimates derived from data mate incidence for the following complications: reported in the literature, to the extent the data per- large bowel injury, peripheral nerve injury and vas- mitted. Where reported data were insufficient, the cular injury. For UTI, the diagnoses were variable panel added its expert opinion in making recom- and reflected different definitions and reporting mendations. The methodology is described in biases in the urologic as contrasted to the gyneco- Chapter 1. logic literature. In general, UTI was more com- Overall, after a thorough review of the literature monly reported in the gynecologic literature. and rigorous analysis of the reported data, the panel Death rate as an outcome was a difficult variable found sufficient acceptable long-term outcomes to assess based on explicit evaluation of the avail- data (48 months and longer) to conclude that surgi- able literature. Because death as a complication of cal treatment of female stress urinary incontinence surgery for SUI is so rare, it is seldom mentioned. is effective, offering a long-term cure in a signifi- Therefore, when considering death rate values, the cant percentage of women. The evidence supports panel attempted to estimate a reasonable rate for all surgery as an initial therapy and as a secondary procedures and agreed upon a death rate of approx- form of therapy after failure of other treatments for imately 5 per 10,000 procedures. This is consistent SUI. with rates for hysterectomy, a pelvic procedure for As explained in Chapter 1 (Methodology), panel which defined mortality rates are available (Wingo, recommendations were graded according to three Huezo, Rubin, et al., 1985). levels of flexibility based on strength of evidence For considering other complications, six general and the panel’s assessment of patient needs and categories were developed. The six categories are: preferences. These three levels—standards, guide- transfusions, general medical complications, intra- lines and options—are defined on pages 9-10 in operative complications, perioperative complica- Chapter 1. Standards have the least flexibility. tions, subjective complications and those complica- Guidelines have considerably more flexibility, and tions requiring surgery. Table 1 displays summary options are the most flexible. probability estimates for these categories, and In this report, none of the panel’s recommenda- Table 2 displays subcategories by type of reported tions fits the definition of a guideline on page 10. complications. The significant and nonsignificant Two recommendations are labeled standards and complications in three of the categories in Table 1 one an option. The labels indicate the strength of were determined for summary purposes by panel the recommendations. Recommendations were opinion. labeled standards if the panel concluded that they In evaluating the complications in each of the should be followed by virtually all health care six categories in Table 1, the panel noted no major providers for virtually all patients. The recommen- differences in complication rates across the four dation labeled an option was given this label, indi- procedure types (retropubic suspensions, transvagi- cating considerable implementation flexibility, nal suspensions, anterior repairs and sling proce- because outcomes evidence in the literature was dures). Transfusion rates range only from 3 to 5 insufficient for a stronger recommendation and percent (median values) across all four procedure because of significant trade-offs (such as a higher types. No complication rate in any of the six cate- long-term cure/dry rate but also higher complica- gories exceeds 16 percent, and most rates are under tion rates for a particular procedure) that could 10 percent. result in divided patient preferences. With regard to synthetic materials used for The type of patient to whom the panel’s recom- slings, the literature suggests higher complication mendations apply is termed the index patient. This rates when using such materials—as shown in patient is defined as an otherwise healthy woman Table 3 on page 25, which compares synthetic with with stress urinary incontinence, either untreated or autologous and homologous materials for specific previously treated (surgically or nonsurgically), complications. without significant pelvic organ prolapse, who has decided to seek surgical treatment. The index (Continued on page 6)

Standard Based on the panel’s expert opinion, the preoperative evaluation of women with symptoms of stress urinary incontinence should comprise the following components: ● History, including impact of symptoms on lifestyle; ● Physical examination: objective demonstration of stress incontinence; ● Urinalysis; ● Other appropriate diagnostic studies designed to assess the following: ◆ Symptom causes—in particular, consideration of the relative contributions of urethral hypermobility, intrinsic sphincteric deﬁ- ciency and detrusor dysfunction; ◆ Frequency and severity of incontinent episodes; ◆ Patient’s expectations from treatment.

Standard ● The index patient should be informed of the available surgical alternatives. Patients should also be informed, for each procedure, of estimated beneﬁts and risks. The choice of treatment should be made between the surgeon and patient, taking into consideration patient preferences and the experience and judgment of the surgeon.

Option ● Although the four major types of procedure groupings—retropubic suspensions, transvaginal suspensions, anterior repairs and sling procedures—have important differences in their outcomes, all four are options for the index patient.

Copyright © 1997 American Urological Association, Inc. Executive Summary Page 5 patient may have urethral hypermobility, ISD or a In particular, on the basis of the preoperative combination of both. evaluation, the surgeon should understand the rela- The panel’s recommendations assume that the tive contributions and underlying causes of urethral surgeon is proficient in diagnostic and therapeutic hypermobility, intrinsic sphincteric deficiency and techniques including the broad categories of surgi- detrusor dysfunction. Although urethral hypermo- cal procedures described in Chapter 2 of this bility is associated with stress urinary incontinence report. in the majority of women, hypermobility often It is assumed also that the index patient has been coexists with ISD. The panel believes that recogni- counseled regarding nonsurgical treatment alterna- tion of this coexistence is crucial to the success of tives. The surgeon may review these alternatives as subsequent surgical intervention. Also, in the part of informed consent. panel’s opinion, the presence of detrusor dysfunction (urgency/urge incontinence, detrusor instability, impaired detrusor contractility, poor bladder Recommendations compliance) can have a deleterious effect on procedure outcomes. A thorough history and physical examination Recommendations: Standards may be sufficient to achieve the goals stated above. However, as noted in Chapter 2 (page 15), further Based on the panel’s expert opinion, the preop- evaluation may be necessary—including, for exam- erative evaluation of women with symptoms of ple, a voiding diary, pad tests and urodynamic test- stress urinary incontinence should comprise the fol- ing. Urinalysis, of course, is necessary to exclude lowing components: urinary tract infection and hematuria. With regard to patient expectations from treat- ● History, including impact of symptoms on ment, she should be accurately informed about the lifestyle; significant risks of either continued or de novo ● Physical examination: objective demonstra- urgency after any operation for stress incontinence, tion of stress incontinence; and that these symptoms tend to persist for a longer ● Urinalysis; time after a sling procedure. Continued or de novo urgency is a major cause for patient dissatisfaction ● Other appropriate diagnostic studies following surgery. designed to assess the following: ◆ Symptom causes—in particular, consideration of the relative contributions of urethral hypermobility, intrinsic sphinc- ● The index patient should be informed of the teric deficiency and detrusor dysfunction; available surgical alternatives. Patients ◆ Frequency and severity of incontinent should also be informed, for each procedure, episodes; of estimated benefits and risks. The choice ◆ Patient’s expectations from treatment. of treatment should be made between the surgeon and patient, taking into consideration patient preferences and the experience and judgment of the surgeon. Although components of diagnostic evaluation are not the main focus of this document, the panel created the above standard because an accurate preoperative evaluation is obviously indispensable for In weighing the potential benefits and harms of selection of a treatment option. As indicated in the each surgical alternative, the surgeon and patient list of recommended evaluation components, the should discuss not only cure/dry and cure/dry/im- essential goals are: (1) to ascertain the impact of a proved rates, but such issues as length of operation, patient’s incontinence on her quality of life; (2) to length of hospital stay and possible complications. objectively demonstrate stress urinary inconti- Patients should be informed especially of the possi- nence; (3) to identify the etiologic factors con- ble occurrence of common complications, with tributing to incontinence; and (4) to identify prog- information on how they would be treated if they nostic indicators. occur.

Page 6 Executive Summary Copyright © 1997 American Urological Association, Inc. If a surgical treatment is a relatively short proce- decreased hospital stay, less likelihood of morbidity dure, with low risk of short-term morbidity, a and/or earlier return to work are paramount, trans- patient may choose this treatment even though it vaginal suspensions are appropriate procedures. has a lower estimated long-term cure/dry rate than Anterior repairs, in the panel’s opinion, are the an alternative treatment that requires more time and least likely of the four major procedure categories poses a higher risk of complications. On the other to be efficacious in the long term. hand, a patient may be willing to accept a longer Among the various transvaginal suspension pro- operation, with greater likelihood of complications cedures, cure/dry rates are similar but complication and short-term morbidity, if there is also greater rates are higher with the Stamey procedure. likelihood of long-term success. Cure/dry and complication rates do not appear sig- The estimates displayed in the comparative out- nificantly different among the various retropubic comes tables (Table 1 on page 19 and Table 2 on suspension procedures and among sling procedures. page 20) are averages based upon evidence from The panel made a further observation regarding the literature. However, these outcome estimates choice of procedure. Not only is the range of surgi- may differ for individual patients. The patient cal options for treating SUI already extremely should be informed of how the estimates will be diverse, but new techniques and procedure modifi- affected by her specific diagnostic condition (i.e., cations continue to emerge. Some of these, as in ISD or detrusor dysfunction). In addition, individ- the past, will not stand the test of experience over ual surgeons may have different outcomes depend- time. Moreover, different surgeons may perform ing on prior training and level of experience with a the same procedure quite differently. The panel particular procedure. believes that surgeons should take these considera- tions into account, together with their own areas Recommendation: Option and levels of expertise and their own previous treatment results, when counseling patients regarding choice of procedure. ● Although the four major types of procedure groupings—retropubic suspensions, transvaginal suspensions, anterior repairs and Research sling procedures—have important differences in their outcomes, all four are options recommendations for the index patient. Research is needed to develop: (1) a standardized lexicon describing the types of incontinence; (2) a standardized diagnostic methodology to Based upon evidence from the literature as indi- define the types of incontinence; and (3) standard- cated by the probability estimates in Table 1 on ized outcome measures. page 19, and upon expert opinion, retropubic sus- Needed as well are: (1) methods to identify pensions and slings are the most efficacious pro- intrinsic sphincteric deficiency, particularly in cedures for long-term success (based on cure/dry patients with concurrent hypermobility; (2) better rates). techniques for management of patients with com- However, in the panel’s opinion, retropubic sus- bined intrinsic sphincteric deficiency and hypermo- pensions and sling procedures are associated with bility; (3) less obstructive techniques for the cor- slightly higher complication rates, including post- rection of patients with hypermobility-associated operative voiding dysfunction, and longer conva- stress incontinence; (4) methods of systematically lescence. In patients who are willing to accept relating preoperative indicators to treatment out- slightly higher complication risks for the sake of comes; and (5) better understanding of the patho- long-term cure, retropubic suspensions and slings physiology underlying SUI. are appropriate choices. In the patient for whom

The Female Stress Urinary Incontinence Clinical The panel initially hoped to make outcome esti- Guidelines Panel developed the recommendations mates of treatment efficacy for various categories in this Report on the Surgical Management of of women, based on factors such as age, weight, Female Stress Urinary Incontinence using an prior pregnancies, prior surgical treatment and the explicit approach to the development of practice presence of urgency and/or detrusor instability. policies (Eddy, 1992), as opposed to an approach However, most of the available data were insuffi- relying solely on panel consensus without descrip- cient to distinguish between outcomes based on tion of the specific evidence considered. such factors. There were some data about the The explicit approach attempts to arrive at prac- effects of preoperative urgency and detrusor insta- tice policy recommendations through mechanisms bility on postoperative urgency, and the resulting that take into account the relevant factors for mak- outcome estimates are displayed and analyzed in ing selections between alternative interventions. Chapter 3 (pages 19 and 20). For other factors that These factors include estimated outcomes from the the panel had hoped would be useful in predicting interventions, patient preferences, costs of the outcomes, the evidence was insufficient to make interventions and (when possible to assess) relative separate outcome estimates. priority of the interventions for a share of limited The review of the evidence started with a litera- health care resources. In estimating outcomes of ture search, extraction and validation of data as the interventions, emphasis is placed on the use of described on pages 9-10. The data available in the scientific evidence. When panel opinion is neces- literature were displayed in evidence tables. From sary, the explicit approach calls for explanation of these tables, with references back to the original why it was necessary and/or discussion of the fac- articles when necessary, the panel developed esti- tors considered. mates of outcomes for four major categories of This report focuses on surgical interventions that procedures—retropubic suspensions, transvaginal may be used to treat stress urinary incontinence in suspensions, anterior repairs, sling procedures— otherwise healthy females who have already and for modifications of these procedures to the decided to seek surgical treatment. The purpose is extent available data permitted. To develop the out- to distinguish between alternative surgical proce- comes estimates, the panel used the FAST*PRO dures and provide estimates of the outcomes that meta-analysis software as described on page 11 for can be expected with each. These outcome esti- combining data extracted from studies that met the mates are intended to help a woman and her physi- panel’s selection criteria (page 10). Outcome esti- cian decide which surgical procedure is best for mates are arrayed in the comparative outcomes her. tables on pages 19 and 20 of Chapter 3 and ana- The panel began the process of evidence review, lyzed on pages 22-25. outcomes estimation and development of practice The panel generated its practice policy recom- policy recommendations by defining precisely mendations from the outcome estimates shown in which patients would be addressed, which alterna- the tables and from the panel’s expert opinion. The tive interventions would be considered and what recommendations were graded according to three outcomes would be relevant to physician/patient levels of flexibility based on the strength of the evi- decision-making. At the beginning stage of the dence and the panel’s assessment of patient needs process, the panel tried to include all surgical inter- and preferences. Levels of flexibility are defined as ventions and procedure modifications, even those follows (Eddy, 1992; American Academy of Family for which the panel suspected little evidence was Physicians, 1996): available, and all the relevant outcomes. Thus, the panel was able to determine what important infor- • Standard: A policy is considered a standard if mation was missing as well as what data were the outcomes of the alternative interventions are available. sufficiently well-known to permit meaningful

Page 8 Copyright © 1997 American Urological Association, Inc. decisions and there is virtual unanimity about reviewed. Some of these references predate the which intervention is preferred. inception of MEDLINE (1966). All citations recov- • Guideline: A policy is considered a guideline if ered were imported into a bibliographic database the outcomes of the interventions are sufficiently software system (Papyrus Bibliography System; well-known to permit meaningful decisions and Research Software Design, Portland, Oregon). an appreciable but not unanimous majority agree The panel reviewed citations and (when avail- on which intervention is preferred. able) abstracts for 5,322 articles on stress incontinence published between 1950 and December • Option: A policy is considered an option if (1) 1993. Each citation (author/title/date) or abstract the outcomes of the interventions are not suffi- was reviewed independently by at least two panel ciently well-known to permit meaningful deci- members. If any panel member thought that the sions, (2) preferences among the outcomes are article might be relevant, it was retrieved. not known, (3) patients’ preferences are divided among alternative interventions, and/or (4) The great majority of citations and abstracts patients are indifferent about the alternative recovered from the MEDLINE database, using the interventions. very broad subject headings “urinary incontinence” and “urinary incontinence, stress,” were clearly not Standards obviously have the least flexibility. relevant to surgical treatment of female SUI. On Guidelines have considerably more flexibility, and the basis of the panel’s citation/abstract review, 457 options are the most flexible. As noted in the defin- of the 5,322 articles were retrieved for detailed arti- itions, options can exist because of insufficient evi- cle review and data extraction. dence or because patient preferences are divided. In Figure A-1 in Appendix A of this report (page the latter case particularly, it is important to con- 59) shows graphically, by year, the number of arti- sider the preferences of individual patients in cles the panel retrieved on the basis of citation/- selecting among alternative interventions. abstract review. Evident in this graph is the In this report, none of the panel’s recommenda- increase over time in the number of papers pub- tions fits the above definition of a guideline. Two lished on stress incontinence. Figure A-2 shows, by recommendations are labeled standards and one an journal, sources of articles from the English lan- option (see pages 27-28). The labels indicate the guage literature. Also see Table A-1 of Appendix A strength of the recommendations. Recommenda- (page 40) for a list of all individual articles from tions were labeled standards if the panel concluded which outcomes data were extracted. (Articles cited that they should be followed by virtually all health in the text of this report, for referencing points of care providers for virtually all patients. The recom- information, were not necessarily among the artic- mendation labeled an option was given this label, les reviewed to extract outcomes data.) indicating considerable implementation flexibility, because outcomes evidence in the literature was insufficient for a stronger recommendation and because of significant trade-offs (such as a higher Article review and long-term cure/dry rate but also higher complication rates for a particular procedure) that could data extraction result in divided patient preferences. The basic tasks of article review and extraction of outcomes data were performed by a paid staff of reviewers selected by the panel chairman and panel Literature search facilitator. All reviewers were residents in urology at Kaiser Permanente Medical Center in Los Ange- To extract outcomes data for surgical interven- les, California. They were trained by the facilitator tions to treat SUI, a literature search was performed coordinator for AUA clinical practice guidelines, utilizing the MEDLINE database. The database aided by other AUA consultants and staff. The was searched several times up to January 1994, panel chairman and panel facilitator closely moni- using the MESH subject headings “urinary inconti- tored the entire process of article review and data nence” and “urinary incontinence, stress.” In addi- extraction. tion, the panel collected appropriate references by To capture as much pertinent information as pos- hand searching bibliographies of articles that were sible from each article, the panel chairman, panel

Copyright © 1997 American Urological Association, Inc. Page 9 facilitator and AUA consultants and staff devised a because of insufficient length of follow-up did pro- comprehensive data extraction form. A sample of vide acceptable short-term complications data. the form is in Appendix D. The selected articles Other selection criteria were established. Articles were divided among the reviewers, who then were rejected if not published in a peer-reviewed reviewed the articles and transcribed the data onto publication in the English language, if the article the form. Two reviewers independently extracted was in abstract form only, if there was concomitant data from each article, after which they met to rec- prolapse surgery, if the data reported were irrele- oncile any differences. If they remained uncertain, vant to surgical management of stress incontinence the panel facilitator or panel chairman made the in the otherwise healthy female, if primary data determination. All reconciled forms were reviewed were absent (as in a review article), if data as by the panel facilitator. Data from the forms were reported could not be extracted to fit the categories entered into a database by staff (who double- in the data extraction form or if data were updated checked all entries). From this database, data were in a more recent article. Articles were also rejected displayed in evidence tables. (As noted in the Intro- for various miscellaneous reasons. For example, duction, a technical supplement to this report, Evi- the panel voted to reject articles dealing with dence Working Papers, is available from the AUA.) Teflon™, which was not FDA approved in the After detailed review and analysis by the entire United States for urologic applications. Teflon™, as panel, the data were combined meta-analytically to of 1997, is undergoing clinical trials for use in such produce the outcome estimates displayed in the applications. outcomes tables on pages 19 and 20 (Tables 1 and Of the 457 articles retrieved for detailed review 2). and data extraction on the basis of citation/abstract Over the course of the review process, all review, 133 were rejected for one or more of the reviewers noted the general lack of consistency in above reasons during the review and data extrac- the incontinence literature in reporting outcomes tion process. The panel, meeting as a group to data. For example, articles often differ greatly in review and analyze the extracted data, rejected an how they define cures and partial cures and in how additional 42 articles for the reasons listed in Table they report the length of time patients remained A-2 on page 58 of Appendix A. The net result was continent following treatment. See Chapter 5 for 282 articles with some type of acceptable outcomes detailed recommendations regarding how informa- data. tion should be reported in future studies. The primary outcome the panel evaluated was whether patients were cured and/or dry (an outcome referred to in this report as “cure/dry”). The Data combination panel used each author’s objective or subjective definition of cure/dry for inclusion of data to com- The extracted data were combined to yield the pute values for outcomes estimates. The panel also outcomes estimates displayed in Tables 1 and 2 on recognized that “cure” does not always equal “dry.” pages 19 and 20, respectively. Combining data “Cure” means being cured of stress incontinence. A allows a clinical practice guidelines panel to make patient who was reported as cured of stress inconti- estimates of outcomes based on the totality of nence, but who reported incontinence due to available evidence. In addition, combining evi- urgency or urge-related incontinence, was consid- dence usually makes differences in treatments more ered cured for purposes of data analysis. apparent since small studies may not have the sta- For length of follow-up, the panel established a tistical power to elucidate the differences. By com- 12-month minimum as an exclusion criterion. Any bining the studies, the effect is similar to having cure/dry data with reported follow-up of less than larger series. This results in more accurate esti- 12 months were excluded from the analysis. For mates with smaller confidence intervals. The proba- articles that reported a range of follow-up, the min- bility of missing true differences is reduced without imum of the range had to be 12 months or longer. increasing the probability of falsely detecting dif- For articles reporting follow-up only as an average ferences. or mean, that average or mean had to be at least 24 Specific methods are available for combining months or the data were excluded. However, some data, depending on the nature of the evidence. For articles from which cure/dry data were excluded the Report on the Surgical Management of Female Stress Urinary Incontinence, the AUA elected to

Page 10 Copyright © 1997 American Urological Association, Inc. use the Confidence Profile Method (Eddy, 1989; In addition, the studies may be dealing with Eddy, Hasselblad and Shachter, 1990), which patients who differ in important ways. For exam- allows analysis of data from studies that are not ple, patients who are offered sling procedures may randomized controlled trials. The FAST*PRO com- be more likely than patients offered anterior repair puter software (Eddy and Hasselblad, 1992) was to have ISD or more severe incontinence (more fre- used in the analysis. quent or greater volume of leakage) and to have Because there are few randomized controlled tri- failed a prior surgical attempt at cure. Yet, most als reporting outcomes for surgical management of reported data, as noted on page 8, are not stratified SUI, the FAST*PRO software was used to combine so that outcomes can be estimated for different cat- the single arms from various clinical series to esti- egories of patients based on pretreatment factors mate outcomes for each intervention. Frequently, such as prior surgery and severity of symptoms. the series that were combined showed very differ- Another problem is that many papers reviewed ent results, thus implying site-to-site variations. by the panel reported on procedures that were These variations may be caused by differences in small variants of the procedures reported in other patient populations, differences in surgical tech- papers. The panel elected to combine such papers nique or differences in the skills of those perform- despite procedural variants, based on the premise ing the technique. If there appeared to be signifi- that these variations were no more than the varia- cant differences and the frequency of occurrence of tions in technique among individual surgeons per- a particular outcome was high enough, a random forming the procedures or even the variations in effects or hierarchical model was used to combine technique of one surgeon over time. the data. If the studies reported similar effects or if Cure/dry data as outcomes of treatment are par- the frequency of occurrence was low, Bayesian ticularly difficult to meta-analyze. One reason is meta-analysis was used. that the methods of obtaining reported results vary. A random effects model assumes that for each Methods run the gamut from simply reading the site there is an underlying true rate for the outcome patient’s chart to conducting a structured evaluation being assessed. It further assumes that this underly- of the patient as recommended in Chapter 5 (pages ing rate varies from site to site. The site-to-site 30-31). variation in the true rate is assumed to be normally A major problem in meta-analyzing cure/dry and distributed. The method of meta-analysis used in cure/dry/improved outcomes data is the impact of analyzing the incontinence surgery data attempts to losses to follow-up. For more accuracy, the length determine this underlying distribution. of time patients remain dry should be reported The results of the Confidence Profile Method actuarially, as if it were a survival statistic. It is incorporated in the FAST*PRO software are proba- rarely treated this way in the literature. Few studies bility distributions. They can be described using a reviewed by the panel used the types of actuarial median probability estimate with a confidence statistics (life tables or Kaplan-Meier) that would interval. For this report, the panel used a 95-per- be most appropriate, and no studies provided cent confidence interval (95% CI). The probability enough information to enable a meta-analysis of of the true value being outside the interval is 5 per- such statistics. The panel was left instead to define cent. time intervals (12-23 months, 24-47 months, 48 months and longer) and combine results of studies that reported dryness within those time periods. If Limitations more than 50 percent of patients were lost to follow-up for a given time period in a study, the panel The data on stress urinary incontinence surgery did not use those results. are based almost entirely on clinical series, rather In part because of loss to follow-up, not all stud- than randomized controlled trials (RCTs). Only ies reported cure/dry data within all three of the three RCTs were found in the literature. The dif- time periods the panel defined. A study might pro- ficulty with using data from clinical series is that vide data for only one or two of the time periods. such data are frequently not comparable, and pool- In order to make maximal use of available data, the ing them can lead to large and uncharacterizable panel elected to include the data reported as long as biases. Already mentioned (page 10) is inconsis- the study met the other selection criteria (page 10). tency in how outcomes data are reported in the lit- However, the results of combining data from differ- erature. ent studies for different time periods are not the

Copyright © 1997 American Urological Association, Inc. Page 11 same as results that would accrue from reporting to determine whether it was reasonable to infer that data for a single group of patients over time. In this complication had in fact not occurred. If so, some instances, the results of the combined data the panel initially inferred a zero rate for that study are anomalous such as when they seem to show and included the data in the meta-analysis. Upon patients improving over time (pages 22-23). further consideration, however, the panel decided The data for complications of surgery presented instead to assume a reasonable death rate for all the panel with fewer meta-analysis problems than procedures of approximately 5 deaths per 10,000 did the cure/dry data. Short-term complications are procedures (see page 24). more easily measured, and loss to follow-up is not In summary, because of limitations such as those a problem. Nevertheless, for complications data as stated above and on pages 29-30 of Chapter 5, the for cure/dry data, almost all the sources are uncon- outcome estimates for different types of surgical trolled clinical series. The differences in patient procedures displayed in the comparative outcomes populations, in techniques, as well as in definitions tables may be biased for cure/dry and cure/dry/im- for a complication such as urinary tract infection, proved outcomes and to some degree even for mean that the results reported in the literature are short-term complications. For example, differences not perfectly generalizable across studies. in patient selection may have had more weight in Also, prior to combining the data, the panel had yielding the results shown than the differing effects to adjust for the fact that many authors do not list of the various procedures. It has also been docu- all complications in their results sections. They mented that patients may not completely report may list only the complications that occur. The posttreatment symptoms, which could make reli- nonoccurrence of an uncommon complication such able measurement of treatment outcomes difficult as perioperative death may not be reported. Yet, if (Korman, Sirls and Kirkemo, 1994). However, the data are combined only from studies in which results displayed in the outcomes tables reflect the death occurs, without taking into account nonoc- best outcome estimates possible at the present time currence, the estimate of frequency will be artifi- and, notwithstanding their limitations, may provide cially high. Therefore, for studies not reporting any some guidance for what to expect from different perioperative deaths, the panel reviewed each study treatments.

when a large residual urine volume is present Overview and the patient is able to void only small amounts. This report focuses on the surgical management 2. Continuous incontinence is the loss of urine on of stress urinary incontinence in the otherwise an uninterrupted basis. It is most commonly seen healthy female. Stress urinary incontinence (SUI) is with urinary tract fistulas, but may occur with the involuntary loss of urine related to increases in severe intrinsic sphincteric deficiency or congen- abdominal pressure resulting from activities such ital abnormalities such as ectopic ureter. as coughing, laughing, lifting and positional 3. Transient incontinence is involuntary urine loss changes. Spontaneous urinary incontinence may associated with a discretely identifiable etiology also occur either when a woman is seated or when such as immobilization or urinary tract infection. she is standing. Gravitational loss of urine (loss of It is often found in institutionalized individuals urine with postural change) occurs in the most or the noninstitutionalized elderly. severe cases. SUI has a multifactorial etiology. Major factors 4. Unaware incontinence is urine loss without include parturition, laxity of the pelvic floor and patient awareness (enuresis). It may occur in the possibly loss of estrogen support at menopause. night or day or in both night and day. Other contributing factors include prior pelvic The panel did not consider for analysis either surgery (especially prior incontinence procedures), incontinence associated with neurologic disease or neurologic dysfunction and pelvic fracture. incontinence associated with significant pelvic SUI may coexist with urgency and/or urge organ prolapse (large cystocele, enterocele, recto- incontinence. Urgency is characterized by a strong, cele, uterine or vault prolapse). sudden, uncomfortable need to void. Urge incontinence is characterized by the precipitate loss of urine accompanied by urgency. Stress incontinence accompanied by urge incontinence is termed mixed incontinence. Diagnostic evaluation An estimated 30-65 percent of women with SUI present with mixed incontinence (McGuire and Essential to the management of SUI is an accu- Savastano, 1985). The components vary in their rate diagnosis. The panel therefore included in this contribution to the presenting symptom complex. report the following descriptive discussion of eval- In some cases, urgency or urge-related incontinence uation components and diagnostic procedures, pre- may be the predominant symptom. When urgency ceded by a discussion of two basic factors to be and/or urge incontinence is a symptom, coexistent evaluated: urethral hypermobility and intrinsic infection, bladder stones, cancer, obstruction and sphincteric deficiency. neurologic disease are excluded during the diagnostic evaluation. Urethral hypermobility and intrinsic Four other types of incontinence may occur, either alone or coexistent with symptomatic stress sphincteric deficiency incontinence, and are identified for treatment if pre- The patient is to be evaluated for the presence of sent during evaluation for SUI: two basic conditions: urethral hypermobility and/or 1. Overflow incontinence, due to bladder outlet intrinsic sphincteric deficiency (ISD). The two may obstruction or poor detrusor contractility, occurs coexist.

Copyright © 1997 American Urological Association, Inc. Page 13 Hypermobility, present in the majority of women ties and quality of life and (2) her expectations for with SUI, is the rotational descent of the proximal treatment. (See Chapter 4, page 27.) urethra and bladder neck into the vagina, associated Of concern in a patient’s medical history are with increases in abdominal pressure that occur neurologic diseases such as multiple sclerosis, with such activities as coughing. Hypermobility stroke, myelodysplasia and Parkinson’s disease can be observed visually or radiographically. Its which can affect bladder and sphincteric function. presence, however, does not necessarily indicate Neurologic symptoms such as weakness, double SUI; many women have urethral hypermobility vision, tremor, tingling or paresthesia are particu- without SUI. If incontinence does occur, an ele- larly important. ment of sphincteric weakness is present. Prior pelvic surgery may affect either bladder or The second factor, ISD, also represents a signifi- urethral function. Procedures such as radical hys- cant component of incontinence in women. The terectomy, previous incontinence surgery and prevalence of ISD is not fully known, but in the abdominoperineal or low anterior resection of the panel’s expert opinion it is present in a significant rectum may alter both bladder and urethral func- percentage of women with stress incontinence. ISD tion. refers to a deficiency in the urethral sphincter func- Medications may cause or contribute to inconti- tion, which is unrelated to urethral support. The nence. For example, alpha antagonists reduce blad- most common reasons for loss of this urethral func- der neck tone and may cause incontinence. Para- tion are prior incontinence surgery, prior pelvic sympatholytics and tricyclics may cause surgery (e.g., radical hysterectomy, abdominoper- diminished detrusor contraction and urinary reten- ineal resection of rectum), neurologic disorders tion with overflow incontinence. (e.g., spina bifida), urethral mucosal atrophy and, in rare cases, radiation exposure. The result is poor urethral mucosal coaptation and incontinence with Physical examination and minimal stress activities. laboratory testing The selection of a surgical procedure should The goal of the physical examination is to objec- reflect the relative contributions of these two condi- tively demonstrate urinary incontinence and to tions, which as noted above may coexist. identify etiologic and prognostic factors such as anatomic or neurologic conditions. History, physical examination Neurologic evaluation may include observation and laboratory testing of the individual’s gait and subtle abnormalities of speech and expression. Sacral dermatomes are Diagnostic evaluation includes a thorough his- assessed by testing perineal sensation, anal sphinc- tory and physical examination supplemented by ter tone (at rest and with volitional contraction) and urinalysis and other appropriate laboratory studies. the bulbocavernosus reflex. The patient’s vagina is examined in the litho- History tomy position. When the patient coughs or per- Relevant historical information includes: symp- forms a Valsalva maneuver, the presence of hyper- tomatic presentation and contribution of stress and mobility of the proximal urethra and bladder neck urge-related components, pertinent obstetric his- is evaluated. This may be facilitated by use of a tory, severity of incontinence (activities producing cotton swab test (Crystle, Charme and Copeland, incontinence), number and type of protective pads 1971). Vaginal inspection will also define the utilized, voiding history (e.g., diurnal frequency degree of vaginal epithelial atrophy and the coexis- and nocturia), the presence of emptying symptoms tence of cystocele, enterocele, rectocele or uterine (e.g., hesitancy, intermittent stream, incomplete prolapse. Examination of the patient in the standing emptying), prior surgical procedures for inconti- position also may be useful. nence and prolapse, neurologic history and current To assess the presence and degree of inconti- medications. A voiding diary and/or pad test, which nence, the patient’s bladder may be filled through a can help elucidate and quantitate symptom history, urethral catheter after the postvoid residual urine may be useful. The following are important to volume has been measured. The bladder is allowed ascertain during preoperative counseling: (1) the to fill by gravity, and the woman is questioned effect of a patient’s symptoms on her daily activi- regarding bladder sensation and urgency. When the

Page 14 Copyright © 1997 American Urological Association, Inc. bladder is comfortably full, the catheter is removed cluded panel analysis of artificial sphincters and and the patient is asked to cough and perform the injectable agents. Valsalva maneuver with increasing force to insti- Historically, surgical procedures to treat SUI gate incontinence. If urine loss continues after the were designed to elevate/suspend and reposition stress maneuver has ended, the presence of detrusor the urethra. The current goal, in the panel’s opin- instability must be considered. If incontinence ion, is to stabilize the proximal urethra and bladder occurs with minimal or no hypermobility, ISD neck (i.e., prevent their descent). Suspension proce- should be considered as an etiology. dures and pubovaginal slings may be used for If incontinence has not been demonstrated, the demonstrable proximal urethral hypermobility in examination may be repeated with the patient in the presence of intact sphincteric function. the standing position with one foot on a stool. The The goal of surgery for ISD is recreation of ure- patient is again asked to cough and perform the thral coaptation, either by external bolstering such Valsalva maneuver to demonstrate urine loss. If uri- as with a sling or artificial sphincter, or by internal nary loss still cannot be demonstrated, the patient bulking as with injectable agents. Pubovaginal may perform a pad test. slings are also an option in those patients with SUI Urinalysis and urine culture are performed to due to combined hypermobility and poor urethral exclude hematuria and urinary tract infection. coaptation. Urine cytology may also be performed in those patients with significant urgency symptoms. Retropubic suspensions Further evaluation may be needed to delineate Retropubic suspensions utilize the strong com- the relative contributions of urethral hypermobility, ponents of the pelvic wall, including Cooper’s liga- intrinsic sphincteric deficiency and detrusor dys- ment and periosteum of the pubis, as anchoring tis- function as well as other compounding factors. sue for sutures placed in the periurethral and This evaluation may include urodynamic evalua- perivesical tissues. The first retropubic suspension tion, cystoscopy and other imaging studies. was reported by Williams (1947), who described suspension of the bladder to the symphysis pubis. Subsequently, Marshall, Marchetti and Krantz (1949) described the first true urethral suspension. Therapy for stress This procedure utilizes four figure-of-eight sutures incontinence placed at the midurethra and bladder neck, which are secured to the symphysis pubis. The vaginal wall sutures do not include epithelium. Krantz altered the procedure to include single suture place- Nonsurgical treatment ment at the bladder neck because of concern Management of SUI includes the option of non- regarding the creation of an iatrogenic urethral surgical therapies. Chief among them are behav- obstruction from the distal sutures (Zimmern, ioral management techniques such as timed void- 1985). Lapides (1974) described a modification uti- ing, pelvic floor exercises, biofeedback, insert lizing the placement of a transverse suture at the devices, functional electrical stimulation and phar- bladder neck. macologic therapy. The panel did not review non- Burch (1961) proposed the placement of four surgical therapies because they are outside the paired sutures in a paravesical location that incor- scope of this report. porated the vaginal wall and Cooper’s ligament. This procedure requires adequate vaginal mobility and depth so that elevation can be performed. Surgical treatment The retropubic paravaginal repair reapproxi- Surgical approaches to SUI are diverse. Grouped mates the endopelvic fascia to the obturator inter- within four major categories of procedures are nus fascia with interrupted sutures placed in a par- many individual procedures and modifications of avesical location (Richardson, Edmonds, Williams, procedures. The four major groupings are retropu- 1981). Sutures are extended into periurethral fascia. bic suspensions, transvaginal suspensions, anterior No suspension sutures are placed at the level of the repairs and sling procedures. Insufficient data pre- bladder neck.

Copyright © 1997 American Urological Association, Inc. Page 15 Complications that may occur with retropubic The Raz suspension (1981) creates lateral vagi- suspensions include the following: urinary reten- nal incisions through which the endopelvic fascia is tion; urethral obstruction; new-onset pelvic pro- dissected and perforated. A monofilament nonab- lapse (especially enterocele formation); vesical, sorbable suture is secured to the vaginal wall, ureteral or bowel injury; persistence or develop- endopelvic fascia and periurethral ligaments. A sus- ment of urgency symptoms after surgery; and pension needle is passed with fingertip guidance, osteitis pubis. Persistent or new-onset detrusor and the monofilament suture is withdrawn and instability also can occur and can result in urge anchored to the fascia in the suprapubic incision. incontinence. Cystoscopy is used to avoid bladder or urethral injury. Transvaginal suspensions The Gittes procedure utilizes local anesthesia and involves a small abdominal incision through Pereyra described the vaginal approach for sur- which a single-pronged needle is blindly passed to gical treatment of SUI in 1959. This procedure the vagina (Gittes and Loughlin, 1987). No incision involves passage of wire sutures from two vaginal is performed in the vagina. The suspension sutures incisions placed laterally at the bladder neck to a are placed on either side of the bladder neck and midline suprapubic incision with a trochar. The secured to the vaginal wall in a helical fashion. passage of the suture is manually guided in close These sutures eventually become covered with proximity to the posterior aspect of the symphysis vaginal epithelium. pubis. Cystoscopy is not performed as part of the procedure. Pereyra and Lebherz (1967) modified Concomitant prolapse procedures may also be the procedure to include incision of the endopelvic performed with these procedures. Complications of fascia, to allow direct finger guidance of the trochar transvaginal needle suspensions are similar to those passage through the retropubic space, and substi- for retropubic procedures and include possible tuted chromic suture for wire. In addition, a vaginal retention, urethral obstruction, bladder and urethral wall plication was performed to decrease suture perforation, vaginal shortening, stenosis, peri- pull-through. In 1982, Pereyra and Lebherz further urethral fibrosis, postoperative inguinal pain and modified the technique, placing the vaginal suture persistent or new-onset urgency. in a helical fashion through the endopelvic fascia on either side of the bladder neck. Anterior repairs Stamey (1973) introduced the concept of a The primary objective of the anterior repair is to Dacron pledget to anchor the fixation suture to the restore vaginal support to the bladder base, using vaginal wall. He described passing needles from the pubocervical fascia. Anterior repair has also two suprapubic incisions to a T-shaped vaginal been used to treat SUI (Miller, 1932). Differing incision under cystoscopic guidance without dis- techniques have employed fascial plication at the ruption of the endopelvic fascia. One suture is proximal urethra alone or in combination with pli- placed on either side of the bladder neck. The cation beneath the base of the bladder. The Kelly abdominal fascia serves as anchoring tissue for the plication (1914) imbricates urethropelvic fascia and fixation sutures. Cystoscopy was added to verify anterior vaginal wall to restore support to the floor suture location and exclude bladder or ureteral of the urethra and bladder neck. The Kennedy pro- injury. Also, anchoring of these sutures directly to cedure (1941) continues this plication to include the pubic tubercle may lessen the risk of postopera- the pubocervical fascia in order to restore support tive suprapubic or groin pain (Leach and Labasky, to the base of the bladder. These two procedures 1989). are often combined as a unified technique. The The Cobb-Ragde technique (1978) creates a con- most significant potential complications following sistent inclusion of a 1 cm bridge of fascia by uti- anterior repair or its modifications are urethral, lizing a double-pronged needle. To further anchor bladder and ureteral injuries. the vaginal suture, a barrel knot is placed in the Ball (1952) described a periurethral imbricating permanent suture as it traverses the bridge of vagi- suture line that corrects urethrocele. Ingelman- nal wall. No dissection of the endopelvic fascia is Sundberg (1952) incorporated pubocervical fascia performed. and endopelvic fascia in a sequential fashion as overlapping layers to improve bladder base support.

Page 16 Copyright © 1997 American Urological Association, Inc. Combined procedures rials is limited by erosion, fistula and infectious complications. Combined procedures attempt to optimize results from more than one approach. The Ball-Burch Possible complications of sling procedures technique (Ball, Knapp, Nathanson, et al., 1966) include prolonged retention (either permanent or combines the Ball anterior repair with the Burch necessitating prolonged intermittent catheteriza- retropubic suspension previously described. The tion), urgency and urge-related incontinence. The Cantor procedure (1971) combines the Kelly plica- panel observed that surgical techniques have tion with the Burch. Because experience with com- changed in recent years with regard to slings. Sur- bined procedures is limited, and the available data geons now recognize the importance of not making are extremely limited, the panel did not attempt to slings overly tight, because of the relationship estimate outcomes for these procedures. between excessive tension and complications. In the panel’s opinion, the incidence of complications is not necessarily higher with excessive tension, but Sling procedures complications that occur tend to last longer. A variety of materials has been utilized for slings, including autologous materials (e.g., rectus Artificial urinary sphincters fascia, fascia lata, dura, skeletal muscle, vaginal wall) and synthetic materials (e.g., mersilene, Another alternative in the management of ISD is Gore-Tex™, Marlex™). the artificial urinary sphincter. Devices have signifi- cantly improved in recent years. However, despite The first autologous sling, described by Goebell the improvements, device malfunction may occur in 1910, utilizes reflected pyramidalis muscle as a due to component failure, cuff erosion or urethral bolster for the urethra. Further modifications atrophy. The panel found the available outcomes included the addition of fascia and plication of the data on artificial sphincters deficient (e.g., small urethra (Frangenheim, 1914; Goebell, 1910; numbers of patients and only short-term follow-up) Stoeckel, 1917). Unacceptable complication rates and decided to exclude the data from the outcomes led to the abandonment of this technique. tables. Aldridge (1942) described the use of rectus fascia strips based on a medial base, which are passed Injectable agents beneath the urethra and sutured in place. McGuire and Lytton (1978), McGuire, Bennett, Konnak, et Periurethral injection of bulking agents repre- al. (1987) and Blaivas and Jacobs (1991) reported sents another option for increasing outlet resistance the use of free rectus slings positioned under the in patients with ISD. Numerous alternative agents vesical neck and secured to the abdominal wall fas- have been proposed for this purpose. The goal of cia with permanent suture. The strip is placed injection therapy is deposition of the bulking agent under minimal tension and anchored to the under- within the submucosa of the proximal urethra and side of the urethra to prevent displacement. Cys- bladder neck. toscopy is used to verify sling position. Critical evaluation of all injectable agents Other sling materials have included fascia lata remains problematic due to the varied reporting of (Beck, Grove, Arnusch, et al., 1974), ox fascia success rates, the use of subjective criteria for (Iosif, 1987) and dura, all implanted in a similar reporting results, nonuniform time intervals fashion to that previously described. Synthetic between injections, nonreporting of intervals materials have included Dacron/Marlex™, mersi- between the last injection and the reported results lene (i.e., gauze hammock sling), Gore-Tex™ and and lack of long-term follow-up. The panel decided Marlex™ (Moir, 1968; Morgan, 1970; Williams and to exclude injectable agents data from the out- Telinde, 1962). The utility of these synthetic mate- comes tables.

For purposes of comparative analysis, outcomes and/or a limited number of patients for whom data of a therapeutic medical intervention can be were reported. Another reason is wide variability in categorized as either beneficial or harmful (Eddy, reported results among studies. 1990, 1992). The Female Stress Urinary Inconti- The outcomes tables display probability esti- nence Clinical Guidelines Panel analyzed in detail mates for four major procedure categories: retropu- available outcomes data for both the potential bic suspensions, transvaginal suspensions, anterior benefits and harms of alternative surgical repairs and pubovaginal sling procedures. The esti- approaches to treating female SUI. Results of the mates for these four major procedure categories are panel’s analysis are summarized as probability esti- listed in parallel columns identified by headings mates in the comparative outcomes tables on pages across the top of each table. The G/P column for 19 and 20 of this chapter. The data extraction and each procedure category shows the number of evidence combination processes that produced the patient groups (G) for a given outcome and the probability estimates are described on pages 9-11 total number of patients (P) in those groups. A of Chapter 1. The raw data are in a technical sup- blank cell in an outcome table means insufficient plement to this report, Evidence Working Papers, extractable data for the given outcome and that par- which is available from the AUA. ticular procedure category. All outcome probability estimates were developed by combining outcomes data for the various The outcomes tables individual procedures that make up each of the four major procedure categories (procedure descriptions in Chapter 2, pages 15-17). For example, in the Outcomes tables like Table 1 on page 19 and first cell of Table 1 on page 19, under the “Retropu- Table 2 on page 20 list “beneficial and harmful bic Suspensions” heading, the median probability health outcomes and their magnitudes, including a estimate for cure/dry at 12-23 months is 84 percent. range of uncertainty for each” (Eddy, 1992). This This estimate was derived from combined cure/dry form of summary display, Eddy notes, allows data for Burch, Marshall-Marchetti-Krantz and “simultaneous consideration of all the important various other individual retropubic suspension pro- outcomes.” cedures. The other probability estimates in the The outcomes tables summarize results of confi- “Retropubic Suspensions” column, including esti- dence profile (FAST*PRO) meta-analyses of com- mates of potential complications, were also derived bined outcomes data from the SUI literature, as from combined outcomes data for the various indi- described in Chapter 1. (“Median” in these tables is vidual procedures that make up the retropubic sus- the median of a probability distribution resulting pension grouping. from FAST*PRO meta-analysis, not the median of Similarly, the estimates in the “Transvaginal Sus- an array of individual study results.) pensions” column were derived from combined out- For most outcomes, a 95-percent confidence comes data for Pereyra/modified Pereyra, Stamey, interval (2.5-97.5%) is reported along with the Gittes and other types of individual transvaginal median probability. As explained in Chapter 1, a suspension procedures. Tables B-2 to B-5 in Appen- 95-percent confidence interval (95% CI) is that dix B display outcome probability estimates for interval such that the probability of the true value individual procedures in the four major categories. being outside the interval is 5 percent. A wide con- The panel found no significant differences between fidence interval indicates considerable uncertainty, individual procedures within each of the four cate- for which there may be several reasons. One com- gories. However, the panel noted that some new mon reason is a limited number of patient groups techniques, although described as modifications of (Continued on page 22)

Figure 2.

Figures 1 and 2 compare in graphic form the same cure/dry and cure/dry/improved probability estimates displayed in Table 1 for the four major procedure categories. The graph’s horizontal axis is marked off (top and bot- tom) in gradations from 0.0 to 1.0. Down the vertical axis (left) are listed the four procedure categories, each with three time intervals as in Table 1. For each time interval, there is a set of two brackets representing a 95 percent conﬁdence interval. The dark square on the line between the brackets represents the median probability estimate. For comparing procedure categories with regard to cure/dry and cure/dry/improved, note where the brackets and squares are located along the horizontal axis. Note also the distance between the two brackets in each set. Narrower brackets (conﬁdence intervals) indicate greater certainty regarding the probability estimate.

Copyright © 1997 American Urological Association, Inc. Page 21 well-known procedure types, are actually quite dif- a therapy for their SUI problem. The patient to ferent from those procedures. For example, a proce- whom the recommendations in this report apply is dure called a laparoscopic Burch procedure is not a woman who has already chosen surgery rather the same as a true Burch procedure. The placement than a nonsurgical therapy. Surgical alternatives of sutures is different. offer her potential for either permanent cure or sat- The panel decided not to include in the out- isfactory long-term improvement. comes tables two types of treatment—artificial uri- However, determining the relative efficacy of the nary sphincters and injectable agents—for which different surgical alternatives is difficult, mainly outcomes data were extracted. Data on artificial because of the way in which outcomes data are sphincters were available for only small numbers reported in the incontinence literature. The principal of patients with short-term follow-up, and most of limitations overall are discussed in Chapter 1 on the available studies of injectable agents deal with pages 11-12. A particular problem for determining Teflon™ which was not FDA approved at the time cure/dry rates is that articles differ in how they of the panel’s analysis. Both types of treatment are define “cure.” Many articles are also inexact in discussed briefly in Chapter 2 (page 17). reporting how long a treatment is effective. The outcomes of interest for this Report on the To ensure as much as possible the accuracy of Surgical Management of Female Stress Urinary the probability estimates displayed in the outcomes Incontinence are listed down the left side of the tables, the panel established strict criteria for outcomes tables. Beneficial outcomes are divided accepting cure/dry data. These criteria, such as into two categories labeled “Cure/Dry” and “Cure/- patient follow-up of 12 months or longer, are Dry/Improved” (Table 1). (See below and on page detailed on page 10 of Chapter 1. 23 for definitions.) Outcome estimates for these In defining “cure,” as noted in Chapter 1, the two categories are also displayed graphically on panel recognized that “cure” does not always equal page 21. Possible undesirable or harmful outcomes “dry.” “Cure” means being cured of stress inconti- are divided into several categories. These include nence. A patient who was reported as cured of postoperative urgency, postoperative retention stress incontinence, but who experienced inconti- greater than four weeks and various categories of nence due to urgency or urge-related incontinence, possible complications. was considered cured for purposes of data analysis. In some cases, surgeons may find the outcomes After analyzing reported cure/dry data in the lit- estimates in the tables at variance with their own erature at time points 12 months to 120 months, the experience. Estimated probabilities, for example, panel defined the three discrete time frames in may seem overoptimistic—possibly reflecting fail- Table 1: 12-23 months follow-up (short term), 24- ure to report negative results in the peer-reviewed 47 months follow-up (intermediate) and follow-up literature and overrepresentation of data from cen- of 48 months and longer (long term). Data for time ters of excellence. Surgeons are encouraged to aug- periods longer than 60 months were sparse and, for ment the tables with their own data when counsel- the most part, not statistically evaluable. ing patients. The panel noted during the literature review process that, for certain procedure types, the cure/dry rates reported at 24-60 months were higher than at 12-18 months. This data aberrancy Analysis of outcomes inflated somewhat the median estimates in the table for long-term follow-up. Careful scrutiny of the lit- categories erature indicated that loss of patients to follow-up and/or patient selection bias probably skewed some The following analysis is by outcomes cate- of the data reported. The panel believes that actual gories in the order listed in Tables 1 and 2, begin- long-term cure/dry rates may be lower than what ning with the cure/dry category in Table 1. Table 1 shows, but estimated that any difference is at most a few percentage points. The panel, there- Cure/dry fore, chose to use the data as reported, with the foregoing explanation, and to display in the table Cure/dry rates are the major indicators of treat- the cure/dry rates as derived from those data. Rates ment efficacy, a prime concern of women choosing are displayed graphically as well on page 21.

Page 22 Copyright © 1997 American Urological Association, Inc. With the above caveats regarding cure/dry rates “improved” rate as well as a “cure/dry” rate. Other longer than 48 months, the rates in the table repre- reports do not specify a “cure/dry” rate, but classify sent cure/dry outcomes to an acceptable degree of patients as “cured/improved,” “improved” or accuracy for retropubic suspensions, transvaginal “failed.” Still other reports omit “improved” and suspensions and slings. The rates indicate that after classify patients as either “cure/dry” or “failed.” 48 months, retropubic suspensions and slings For these reports, the panel inferred an “improved” appear to be more efficacious than transvaginal rate of 0 percent. suspensions and anterior repairs. For anterior repairs, however, the rates after 24 months are Urgency/urge incontinence anomalous—with a sharp increase in cure/dry status at 24-47 months (from 68% to 85%), then a Probability estimates of postoperative urgency sharp decline after 48 months (to 61%). These rates are displayed relative to patients’ preoperative sta- are believed to represent an aberrancy of data tus. Patients are divided into four subgroups with reporting rather than true outcomes. Such results varying combinations of urodynamically diag- occur because, as explained in Chapter 1 (pages 11- nosed, preoperative symptomatic urgency and 12), not all studies report outcomes at all time detrusor instability (DI). In the first subgroup are points. patients with urgency and DI preoperatively. In the For ISD therapy, cure/dry results are incom- next subgroup are patients with urgency but no DI pletely reported in the literature because recogni- preoperatively. In the third subgroup are patients tion of ISD as a diagnostic entity is relatively new. with no urgency but with DI preoperatively. The In the panel’s opinion, sling procedures are the fourth subgroup comprises patients with no most effective type of treatment for ISD patients. urgency and no DI preoperatively. This evaluation However, the available data are insufficient to by subgroup quantitates the percentages of persis- determine whether or not other types of procedures tent and de novo urgency. might be equally effective. Analysis of the four patient subgroups revealed The panel also attempted to determine from the no major statistical differences between transvagi- literature the degree to which factors such as nal suspensions, sling procedures and retropubic patient age and prior surgery have an impact on suspensions with regard to postoperative urgency. cure/dry outcomes. Factors the panel evaluated Insufficient data exist to evaluate anterior repairs include the following: prior incontinence surgery, for this outcome. A tendency toward increased per- subjective urgency, urodynamically proven detrusor sistent urgency is apparent in the first subgroup instability (DI), menopausal status, parity, prior (urgency and DI preoperatively) for retropubic sus- hysterectomy and age. Because of incomplete data pensions (66%), as compared to transvaginal sus- and varying definitions of data, the panel could pensions (54%) and slings (46%). In general, if make no determinations regarding the effects of urgency and DI are present preoperatively, there is these variables on cure/dry rates. significant risk of these symptoms persisting postoperatively. If either is absent, the risk of postoper- Cure/dry/improved ative urgency is reduced. However, no accurate statistical statements can be made regarding these Cure/dry rates alone do not fully represent all tendencies because of small total sample sizes. potential treatment benefits. Many patients, even if For new-onset postoperative urgency with pre- not completely cured of their SUI problem, report operative DI, sling procedures show an increased very substantial improvement and consider the rate (20%) compared to retropubic suspensions surgery successful. For this reason, the panel (4%) and transvaginal suspensions (7%). Again no included a “Cure/Dry/Improved” category in the accurate statistical evaluation could be performed outcomes tables (cure/dry plus improved). As with these data because of small sample sizes. would be expected, cure/dry/improved rates are higher than cure/dry rates alone for all treatment types across all three time frames. Cure/dry/im- Retention proved rates, together with cure/dry rates, are rep- The panel determined that two time periods resented graphically on page 21. should be reported for urinary retention: (1) tempo- Cure/dry/improved data are variously reported in rary retention greater than four weeks and (2) per- the literature. Some reports clearly specify an manent retention. For temporary retention, the

Copyright © 1997 American Urological Association, Inc. Page 23 panel recognized that the data reflect varying prac- It has been observed that surgery for SUI may tice patterns and changes in hospitalization prac- precede the development of pelvic prolapse. Suffi- tices and medical management over the time frame cient data could not be identified for establishing a of the literature reviewed. The data cannot be causal relationship between incontinence surgery meaningfully combined because of differing and resultant de novo postoperative prolapse. The lengths of hospital stay and studies measuring panel assumes that in patients with SUI and signs retention at different points in time. or symptoms of pelvic prolapse, the prolapse would The estimated probability of temporary urinary be appropriately evaluated preoperatively and retention lasting longer than four weeks is 5 per- treated at the time the SUI is corrected. cent for both retropubic and transvaginal suspensions and 8 percent for sling procedures. For ante- Other complications of surgery rior repairs, the retention data were insufficient to Although, overall, a significant amount of infor- generate a probability estimate. mation on complications was evaluated during the For permanent retention, there are no accurate literature review, there was insufficient information data to date. In the panel’s opinion, the risk is to estimate incidence for the following complica- somewhat higher for sling procedures than for tions: large bowel injury, peripheral nerve injury other procedures. However, for all procedures, and vascular injury. For urinary tract infection panel opinion is that the risk of permanent reten- (UTI), the diagnoses were variable and reflected tion generally does not exceed 5 percent. different definitions and reporting biases in the urologic as contrasted to the gynecologic literature. In Length of hospital stay and general, UTI was more commonly reported in the resumption of normal activities gynecologic literature. Days in the hospital as reported in the literature Death again reflect practice patterns that in the panel’s opinion are no longer current. Assuming an uncom- Death rate as an outcome was a difficult variable plicated stay, based on current practice, the panel to assess based on explicit evaluation of the avail- determined that length of hospital stay for each able literature. Because death as a complication of treatment type ranges from 0 to 5 days, with trans- surgery for SUI is so rare, it is seldom mentioned. vaginal suspensions and anterior repairs requiring Therefore, when considering death rate values, the the shortest length of stay. panel attempted to estimate a reasonable rate for all procedures and agreed upon a death rate of approx- The panel considered resumption of normal imately 5 per 10,000 procedures. This is consistent physical activity after surgery to be an important with rates for hysterectomy, a pelvic procedure for outcomes variable. Few data were found in the lit- which defined mortality rates are available (Wingo, erature indicating time periods for returning to Huezo, Rubin, et al., 1985). baseline activity levels. The panel agreed on six weeks as the typical length of time before resump- Complication categories tion of normal physical activities. For considering other complications, six general Obstruction and prolapse categories were developed. The six categories are: transfusions, general medical complications, intra- In analyzing specific outcomes of incontinence operative complications, perioperative complica- surgery, the panel attempted to analyze obstruction tions, subjective complications and those complica- diagnosed by urodynamics and pelvic prolapse as tions requiring surgery. Summary probability well as urinary retention and other possible compli- estimates for the six categories are displayed in cations of surgery. However, the obstruction data Table 1. were variable and incomplete, with differing defini- The significant and nonsignificant complications tions and a lack of objective data. Urodynamic diag- in three of the categories in Table 1 (General Med- nosis of obstruction was noted to be poorly stan- ical, Intraoperative and Perioperative) were deter- dardized and often dependent on subjective mined for summary purposes by panel opinion. symptoms rather than defined pressure/flow criteria. Acute cholecystitis is an example of a significant

Autologous Materials Homologous Materials Synthetic materials Complications (1,715 pts.) (414 pts.) (1,515 pts.) Vaginal erosion 1 pt. (.0001) 0 10 pts. (.007) Urethral erosion 5 pts. (.003) 0 27 pts. (.02) Fistula 6 pts. (.003) 0 4 pts. (.002) Wound sinus 3 pts. (.002) 0 11 pts. (.007) Wound infection 11 pts. (.006) 9 pts. (.02) 15 pts. (.009) Seroma 6 pts. (.003) 0 1 pt. (.0007)

(though uncommon) general medical abdominal grouping, the panel defined and was able to gener- complication, and acute gastric dilatation an exam- ate probability estimates for three subgroups: ple of a nonsignificant abdominal complication. abdominal, cardiovascular and pulmonary compli- Urinary tract infections and wound complications cations. Under “Intraoperative Complications,” the (such as wound seroma) are examples of common, subgroups are bladder, ureteral and urethral compli- usually insignificant perioperative complications. A cations. Within the “Perioperative” group, the panel complete list of both significant and nonsignificant generated probability estimates for bleeding, UTI complications reported in the literature is in Tables and wound complications. Under “Subjective Com- B-6 to B-8 on pages 66-67 of Appendix B. plications,” the subgroups are dysuria, pain and In the six categories, the panel noted no major sexual dysfunction. Finally, for “Complications differences in complication rates between the four Requiring Surgery,” fistula and stone formation procedure types in Table 1 (retropubic suspensions, constitute the subgroups. transvaginal suspensions, anterior repairs and sling procedures). In the transfusion category, rates range Complication rates for synthetic from 3 to 5 percent (median values) across all four sling materials procedure types. In the other five complication categories, rates are also similar across the four proce- With regard to synthetic materials used for dure types. No complication rate in any category slings, the literature suggests higher complication exceeds 16 percent, and most rates are under 10 rates when using such materials, as shown in Table percent. 3, which shows the number of patients who experi- Further subcategorization of the complication enced specific complications with autologous mate- headings was possible based on the kinds of com- rials (e.g., rectus fascia and fascia lata), homolo- plications reported. These probability estimates are gous materials (e.g., nonsynthetic, nonself grafts; displayed in Table 2. For the “General Medical” such as porcine xenografts) and synthetic materials.

Overview Flexibility of panel recommendations

The practice policy recommendations in this As explained in Chapter 1, panel recommenda- chapter are to help patients and physicians select tions were graded according to three levels of flexi- surgical therapies for female stress urinary inconti- bility based on strength of evidence and the panel’s nence (SUI). The classic SUI symptom is involun- assessment of patient needs and preferences. Defin- tary loss of urine during stress activities such as itions and explanations of these three levels are coughing, laughing, lifting and positional changes. repeated below from Chapter 1: The two basic factors to be evaluated are urethral ● Standard: A policy is considered a standard hypermobility and intrinsic sphincteric deficiency if the outcomes of the alternative interven- (ISD). Hypermobility, present in the majority of tions are sufficiently well-known to permit women with SUI, is the rotational descent of the meaningful decisions and there is virtual una- proximal urethra and bladder neck into the vagina, nimity about which intervention is preferred. associated with increases in abdominal pressure ● Guideline: A policy is considered a guideline that occur with stress activities. ISD refers to a if the outcomes of the interventions are suffi- deficiency in the urethral sphincter function, which ciently well-known to permit meaningful is unrelated to urethral support. The result is decisions and an appreciable but not unani- sphincteric incontinence with minimal stress activi- mous majority agree on which intervention is ties. Hypermobility and ISD may coexist; and preferred. selection of a surgical procedure, as will be empha- ● Option: A policy is considered an option if sized further, should reflect the relative contribu- (1) the outcomes of the interventions are not tions of these two factors. (For a fuller discussion sufficiently well-known to permit meaningful of SUI, as well as other types of incontinence that decisions, (2) preferences among the out- may be present, see page 13 of Chapter 2.) comes are not known, (3) patients’ prefer- The Female Stress Urinary Incontinence Clinical ences are divided among alternative interven- Guidelines Panel generated the recommendations tions, and/or (4) patients are indifferent about in this chapter based on outcomes estimates the alternative interventions. derived from data reported in the literature, to the Standards obviously have the least flexibility. extent the data permitted. Where reported data Guidelines have considerably more flexibility, and were insufficient, the panel added its expert opin- options are the most flexible. As noted in the defin- ion in making recommendations. The methodology itions, options can exist because of insufficient evi- is described in Chapter 1. dence or because patient preferences are divided. In Overall, after thorough review of the literature the latter case particularly, it is important to con- and rigorous analysis of the reported data, the panel sider the preferences of individual patients in found sufficient acceptable long-term outcomes selecting among alternative interventions. data (48 months and longer) to conclude that surgi- In this report, none of the panel’s recommenda- cal treatment of female stress urinary incontinence tions fits the above definition of a guideline. Two is effective, offering a long-term cure in a signifi- recommendations are labeled standards and one an cant percentage of women. The evidence supports option. The labels indicate the strength of the rec- surgery as an initial therapy and as a secondary ommendations. Recommendations were labeled form of therapy after failure of other treatments for standards if the panel concluded that they should SUI. be followed by virtually all health care providers

Page 26 Copyright © 1997 American Urological Association, Inc. for virtually all patients. The recommendation labeled an option was given this label, indicating ◆ Symptom causes—in particular, consid- considerable implementation flexibility, because eration of the relative contributions of outcomes evidence in the literature was insufficient urethral hypermobility, intrinsic sphinc- for a stronger recommendation and because of sig- teric deficiency and detrusor dysfunction; nificant trade-offs (such as a higher long-term ◆ Frequency and severity of incontinent cure/dry rate but also higher complication rates for episodes; a particular procedure) that could result in divided ◆ patient preferences. Patient’s expectations from treatment.

Although components of diagnostic evaluation The index patient are not the main focus of this document, the panel created the above standard because an accurate pre- The type of patient to whom the panel’s recom- operative evaluation is obviously indispensable for mendations apply is termed the index patient. This selection of a treatment option. As indicated in the patient is defined as an otherwise healthy woman list of recommended evaluation components, the with stress urinary incontinence, either untreated or essential goals are: (1) to ascertain the impact of a previously treated (surgically or nonsurgically), patient’s incontinence on her quality of life; (2) to without significant pelvic organ prolapse, who has objectively demonstrate stress urinary inconti- decided to seek surgical treatment. The index nence; (3) to identify the etiologic factors con- patient may have urethral hypermobility, ISD or a tributing to incontinence; and (4) to identify prog- combination of both. nostic indicators. The panel’s recommendations assume that the In particular, on the basis of the preoperative surgeon is proficient in diagnostic and therapeutic evaluation, the surgeon should understand the rela- techniques including the broad categories of surgi- tive contributions and underlying causes of urethral cal procedures described in Chapter 2 of this hypermobility, intrinsic sphincteric deficiency and report. detrusor dysfunction. Although urethral hypermo- It is assumed also that the index patient has been bility is associated with stress urinary incontinence counseled regarding nonsurgical treatment alterna- in the majority of women, hypermobility often tives. The surgeon may review these alternatives as coexists with ISD. The panel believes that recogni- part of informed consent. tion of this coexistence is crucial to the success of subsequent surgical intervention. Also, in the panel’s opinion, the presence of detrusor dysfunction (urgency/urge incontinence, detrusor instabil- Recommendations: ity, impaired detrusor contractility, poor bladder Standards compliance) can have a deleterious effect on procedure outcomes. Based on the panel’s expert opinion, the preop- A thorough history and physical examination erative evaluation of women with symptoms of may be sufficient to achieve the goals stated above. stress urinary incontinence should comprise the fol- However, as noted in Chapter 2 (page 15), further lowing components: evaluation may be necessary—including, for example, a voiding diary, pad tests and urodynamic testing. Urinalysis, of course, is necessary to exclude ● History, including impact of symptoms on urinary tract infection and hematuria. lifestyle; With regard to patient expectations from treat- ● Physical examination: objective demonstra- ment, she should be accurately informed about the tion of stress incontinence; significant risks of either continued or de novo urgency after any operation for stress incontinence, ● Urinalysis; and that these symptoms tend to persist for a longer ● Other appropriate diagnostic studies time after a sling procedure. Continued or de novo designed to assess the following: urgency is a major cause for patient dissatisfaction following surgery.

Copyright © 1997 American Urological Association, Inc. Page 27 ● The index patient should be informed of the sling procedures—have important differ- available surgical alternatives. Patients ences in their outcomes, all four are options should also be informed, for each procedure, for the index patient. of estimated benefits and risks. The choice of treatment should be made between the surgeon and patient, taking into consideration patient preferences and the experience Based upon evidence from the literature as indi- and judgment of the surgeon. cated by the probability estimates in Table 1 on page 19, and upon expert opinion, retropubic suspensions and slings are the most efficacious proce- In weighing the potential benefits and harms of dures for long-term success (based on cure/dry each surgical alternative, the surgeon and patient rates). should discuss not only cure/dry and cure/dry/im- However, in the panel’s opinion, retropubic sus- proved rates, but such issues as length of operation, pensions and sling procedures are associated with length of hospital stay and possible complications. slightly higher complication rates, including post- Patients should be informed especially of the possi- operative voiding dysfunction, and with longer ble occurrence of common complications, with convalescence. In patients who are willing to information on how they would be treated if they accept slightly higher complication rates for the occur. sake of long-term cure, retropubic suspensions and If a surgical treatment is a relatively short proce- slings are appropriate choices. In the patient for dure, with low risk of short-term morbidity, a whom decreased hospital stay, less likelihood of patient may choose this treatment even though it morbidity and/or earlier return to work are para- has a lower estimated long-term cure/dry rate than mount, transvaginal suspensions are appropriate an alternative treatment that requires more time and procedures. Anterior repairs, in the panel’s opinion, poses a higher risk of complications. On the other are the least likely of the four major procedure hand, a patient may be willing to accept a longer types to be efficacious in the long term. operation, with greater likelihood of complications Among the various transvaginal suspension pro- and short-term morbidity, if there is also greater cedures, cure/dry rates are similar but complication likelihood of long-term success. rates are higher with the Stamey procedure. The estimates displayed in the comparative out- Cure/dry and complication rates do not appear sig- comes tables (Table 1 on page 19 and Table 2 on nificantly different among the various retropubic page 20) are averages based upon evidence from suspension procedures and among sling procedures. the literature. However, these outcome estimates The panel made a further observation regarding may differ for individual patients. The patient choice of procedure. Not only is the range of surgi- should be informed of how the estimates will be cal options for treating SUI already extremely affected by her specific diagnostic condition (i.e., diverse, but new techniques and procedure modifi- ISD or detrusor dysfunction). In addition, individ- cations continue to emerge. Some of these, as in ual surgeons may have different outcomes depend- the past, will not stand the test of experience over ing on prior training and level of experience with a time. Moreover, different surgeons may perform particular procedure. the same procedure quite differently. The panel believes that surgeons should take these considera- tions into account, together with their own areas Recommendation: Option and levels of expertise and their own previous treatment results, when counseling patients regarding choice of procedure.

● Although the four major types of procedure groupings—retropubic suspensions, transvaginal suspensions, anterior repairs and

Page 28 Copyright © 1997 American Urological Association, Inc. Chapter 5 – Literature limitations, recommended standards of efficacy for evaluation of treatment outcomes and recommendations for future research

tions, and only a small number of studies Limitations reviewed by the panel actually classified the in the literature patients in this manner. Furthermore, the panel unanimously agreed that it is important to record the presence or absence of urinary urgency, urge As discussed in Chapter 1 (pages 8-11), the incontinence and detrusor instability, both pre- Female Stress Urinary Incontinence Clinical and posttreatment. This was rarely done in the Guidelines Panel developed its recommendations studies the panel reviewed. utilizing an explicit approach (Eddy, 1992), with ● emphasis on scientific evidence reported in the lit- Lack of standardized outcomes criteria. erature. As also discussed in Chapter 1 (pages 11- There are no standardized methods of recording 12), the panel encountered numerous limitations in outcomes. Moreover, the vast majority of studies under panel review did not even define the meth- the literature. ods by which incontinence was assessed. Of the panel’s recommendations, two are stan- ● dards relating to general criteria for selecting and Lack of specific time intervals over which informing surgery patients. However, because of a results were reported. Although many studies dearth of studies that meet minimum criteria for claimed to have long-term follow-ups, the good science in conducting clinical trials and majority did not record the total number of reporting the results, the panel was unable to use patients treated, the number actually evaluated evidence-based data to develop either standards or and the number lost to follow-up over the follow-up period. Most studies had statements such guideline-level recommendations specifically as the following: “100 women were followed for related to choosing surgical procedures for individ- 1-10 years with a mean follow-up of 5 years.” ual patients. Only an option-level recommendation This kind of statement does not allow the draw- was possible. ing of meaningful conclusions about follow-up Chapter 5 summarizes the chief limitations in beyond the first year. the literature that prevented a stronger recommen- ● dation with regard to choices of surgical procedure, Lack of uniformity in terminology describing addresses these limitations by specifying minimal surgical procedures. Many authors described standards for clinical trials and makes recommen- significant modifications of surgical technique under one name, but the actual technique they dations for future research. The following is a sum- used was closer to a technique known by another mary of the limitations: name. For example, one author used the name ● Lack of prospective, randomized, controlled “Stamey bladder neck suspension” in the title of trials. Prospective, randomized, controlled tri- the paper, but the text indicated a technique that als, although optimal for providing reliable data, was almost identical to the Raz procedure. are almost never undertaken. ● Failure of authors to indicate whether their ● Lack of standardized diagnostic criteria. The study population was a new or updated series. panel unanimously agreed that it is conceptually A number of authors published their results as important to classify the cause(s) of stress incon- often as every 1-3 years, and in most instances it tinence as urethral hypermobility, intrinsic was not possible to determine how many of the sphincteric deficiency or both. Yet, there are no patients represented follow-up and how many definitive diagnostic tools to make these distinc- were new patients.

Copyright © 1997 American Urological Association, Inc. Page 29 ● Failure of authors to describe the complica- study, tests of all drug therapies should be double- tions and morbidities of the surgery. Compli- blinded and placebo controlled. cations and morbidities are not described in the Whenever repeated therapies are contemplated literature in a consistent way, often making it (such as periurethral injections), the indications for impossible to determine their true incidence. retreatment and the time interval over which retreatment is instituted should be specified. The efficacy assessments should be conducted at a Standards of efficacy specified time interval after the last treatment. for clinical trials Pretreatment evaluation The pretreatment evaluation should consist of a The recommendations in this section were structured micturition history and/or questionnaire, adapted from the “Standards of Efficacy for Evalu- structured physical examination, micturition diary, ation of Treatment Outcomes in Urinary Incon- a quantitative measure of urinary loss such as a pad tinence,” developed by a multidisciplinary commit- test, urodynamics testing and a quality-of-life tee of the Urodynamics Society and approved by assessment. both the American Urological Association and the Urodynamics Society (Blaivas, Appell, Fantl, et al., The history should specifically include: (1) the 1997). These are minimal standards to be used in patient’s age; (2) previous operations that might clinical trials for assessing the efficacy of urinary affect the results, including pelvic and/or inconti- incontinence therapies. Widespread adoption of nence surgery and abdominalperineal resection of these standards would obviate many of the prob- the rectum; (3) previous pelvic irradiation; (4) neu- lems the panel encountered in reviewing and ana- rologic conditions known to affect micturition; (5) lyzing outcomes data, especially problems involv- menstrual and obstetric history; and (6) concurrent ing data inconsistencies. medications known to affect micturition. The micturition history and/or questionnaire should include at a minimum the following ele- General recommendations ments: number of micturitions per day; number of As a general consideration, all clinical trials micturitions per night; number of incontinent should consist of pre- and posttreatment evalua- episodes per day; number of incontinent episodes tions adhering to the specific standards recom- per night; type of incontinence symptoms (e.g., mended in this section. Protocols should further stress, urge, unconscious, continuous leakage); specify the criteria by which treatment success or voiding symptoms; subjective evaluation of sever- failure is determined. ity of symptoms, such as a “bother” index; and Posttreatment evaluation of surgical, prosthetic type and number of pads used. and implantation therapies should be conducted no The structured physical examination should be less often than 1, 6 and 12 months after treatment. conducted with a comfortably full bladder and Ideally, evaluation should be done at yearly inter- include a neurourologic and a vaginal examination. vals thereafter. With regard to surgical therapies, a The neurourologic examination should assess peri- minimum of five-year follow-up is highly desir- anal sensation, anal sphincter tone and control and able. The following data should be clearly bulbocavernosus reflex. It should also include a described at each posttreatment interval: (1) the brief neurologic examination to discriminate nor- number of patients treated during that interval of mal, paraplegic, quadriplegic, hemiplegic, demen- time; (2) the number of patients actually evaluated; tia, etc. The vaginal examination should include and (3) the number of patients lost to follow-up demonstration of urinary leakage: spontaneous/con- and the reasons why. tinuous, synchronous with stress and after stress. It Some therapies, including most of those involv- should detect the presence and degree of cystocele, ing pharmacologic agents, exert their effects only urethrocele, uterine prolapse/vaginal vault prolapse, during active treatment. These should be evaluated enterocele and rectocele. An estimate of urethral at intervals dictated by the expected outcome, but hypermobility (such as a cotton-swab test) should no less often than monthly. After a successful pilot be done.

Page 30 Copyright © 1997 American Urological Association, Inc. The micturition diary, self-reported by the at each follow-up visit, a quality-of-life assessment, patient, should include time of micturition, time a structured physical examination with full bladder and type of incontinence and the voided volume. at appropriate intervals, micturition diary at each The pad test should be quantitative or semiquanti- follow-up, pad test at each follow-up and measure- tative. A quantitative pad test estimates the volume ment of uroflow and postvoid residual at least once of urine loss (for example, by weighing pads). A and at appropriate intervals thereafter. The exact semiquantitative pad test describes the amount of method by which the data for analysis was loss (such as large or small). Urinary dyes such as obtained should be specified (e.g., retrospective or Pyridium™ may be useful for this. The specific prospective chart review or analysis by indepen- technique of the pad test should be delineated. dent researcher). The latter is the preferred method. For urodynamic evaluation, the most compre- Specific complications and morbidities should be hensive technique is videourodynamics. The mini- noted including: (1) postoperative death; (2) uri- mum evaluation should consist of the following: nary retention (e.g., incidence, duration and cystometry (liquid) with simultaneous measure- whether it was an expected or unexpected out- ment of vesical and abdominal pressure for deter- come); and (3) incidence of postoperative urinary mination of detrusor pressure, detrusor pressure/- frequency, urgency and urge incontinence (each as uroflow study and simple uroflow. A measure, or a separate data point) and whether persistent or a estimate of sphincteric strength and urethral hyper- de novo occurrence. mobility, such as leak point pressure and cotton- swab test, should be performed in order to assess for the relative contribution of urethral hypermobility and intrinsic sphincteric deficiency. Research The cause of incontinence should be diagnosed recommendations as urethral hypermobility, intrinsic sphincteric deficiency or both. How the diagnosis was made should be stated (e.g., examination, cotton-swab Research is needed to develop: (1) a standard- test, cystourethrogram, ultrasound, leak point pres- ized lexicon describing the types of incontinence; sure). In addition, the presence or absence of (2) a standardized diagnostic methodology to urgency and/or urge incontinence should be noted define the types of incontinence; and (3) standard- as well as the presence of detrusor instability. If ized outcome measures. detrusor instability is present at cystometry, it Needed as well are: (1) methods to identify should be categorized as symptomatic or asympto- intrinsic sphincteric deficiency, particularly in matic. patients with concurrent hypermobility; (2) better techniques for management of patients with combined intrinsic sphincteric deficiency and hypermo- Posttreatment bility; (3) less obstructive techniques for the correction of hypermobility-associated stress evaluation incontinence; (4) methods of systematically relating preoperative indicators to treatment outcomes; The posttreatment evaluation should consist of a and (5) better understanding of the pathophysiol- structured micturition history and/or questionnaire ogy underlying SUI.

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Modified ment. Acta Obstet Gynecol Scand 1969;48:575-88. Pereyra procedure for stress incontinence. J Urol 1981;125:787-9. Sloan WR, Barwin BN. Stress incontinence of urine: a retrospective study Rodrigues Netto N Jr, Lemos GC, Palma PCR, Fiuza JL. Comparison of of the complications and late results of simple suprapubic suburethral the Stamey bladder neck suspension procedure with a modified endo- fascial slings. J Urol 1973;110:533-6. scopic suspension for the treatment of stress urinary incontinence. Eur Smart RF. Polytef paste for urinary incontinence. Aust N Z J Surg Urol 1988;15:62-5. 1991;61:663-6. Rodriguez VJ. Late results of the endourethral injection of Teflon in stress Smith JL. Fascia lata paraurethrovesical suspension for the correction of urinary incontinence. J Urol (Paris) 1987;93:537-9. stress urinary incontinence in the woman. Am J Surg 1982;143:542-4. Ross RA, Shingleton HM. Vaginal prolapse and stress urinary inconti- Spencer JR, O’Conor VJ Jr, Schaeffer AJ. A comparison of endoscopic nence. West Vir Med J 1969;65:77-9. suspension of the vesical neck with suprapubic vesicourethropexy for Rost A, Fiedler U, Fester C. Comparative analysis of the results of sus- treatment of stress urinary incontinence. J Urol 1987;137:411-5. pension-urethroplasty according to Marshall-Marchetti-Krantz and of Spencer TS, Jequier AM, Kersey HJG. The gauze-hammock operation in urethrovesicopexy with adhesive. Urol Int 1979;34:167-75. the treatment of persistent stress incontinence. J Obstet Gynaecol Br Rottenberg RD, Weil A, Brioschi P-A, Bischof P, Krauer F. Urodynamic Commonw 1972;79:666-9. and clinical assessment of the Lyodura sling operation for urinary stress Stamey TA. Endoscopic suspension of the vesical neck for urinary incon- incontinence. Br J Obstet Gynaecol 1985;92:829-34. tinence. Surg Gynecol Obstet 1973;136:547-54. Rydhström H, Iosif CS. Urodynamic studies before and after retropubic Stamey TA. Endoscopic suspension of the vesical neck for urinary incon- colpo-urethrocystopexy in fertile women with stress urinary inconti- tinence in females. Report on 203 consecutive patients. Ann Surg nence. Arch Gynecol Obstet 1988;241:201-7. 1980;192:465-71. Sand PK, Bowen LW, Ostergard DR, Brubaker L, Panganiban R. The Stamey TA, Schaeffer AJ, Condy M. Clinical and roentgenographic evalu- effect of retropubic urethropexy on detrusor stability. Obstet Gynecol ation of endoscopic suspension of the vesical neck for urinary inconti- 1988;71:818-22. nence. Surg Gynecol Obstet 1975;140:355-60. Sand PK, Bowen LW, Ostergard DR, Nakanishi AM. Hysterectomy and Stanton SL. Female stress incontinence. Treatment options and indica- prior incontinence surgery as risk factors for failed retropubic cys- tions. Urologe 1991;29:239-43. tourethropexy. J Reprod Med 1988;33:171-4. Stanton SL. Stress incontinence: why and how operations work. Clin Sand PK, Bowen LW, Panganiban R, Ostergard DR. The low pressure Obstet Gynaecol 1985;12:369-77. urethra as a factor in failed retropubic urethropexy. Obstet Gynecol Stanton SL. Suprapubic approaches for stress incontinence in women. J 1987;69:399-402. Am Geriatr Soc 1990;38:348-51. Sander S, Mathisen W. Stress incontinence. A follow-up study of retropu- Stanton SL. Surgery of urinary incontinence. Clin Obstet Gynaecol bic suspension. Urol Int 1967;22:324-31. 1978;5:83-108. Sant JP. Artificial urinary sphincter. Restoring continence. Aorn J Stanton SL. Surgical management of urethral sphincter incompetence. 1986;43:866-75. Clin Obstet Gynecol 1990;33:346-57. Schaeffer AJ. Treatment of recurrent urinary incontinence. Clin Obstet Stanton SL, Brindley GS, Holmes DM. Silastic sling for urethral sphincter Gynecol 1984;27:459-73. incompetence in women. Br J Obstet Gynaecol 1985;92:747-50.

Page 38 Copyright © 1997 American Urological Association, Inc. Stanton SL, Cardozo LD. A comparison of vaginal and suprapubic surgery Varner RE. Sparks JM. Surgery for stress urinary incontinence. Surg Clin in the correction of incontinence due to urethral sphincter incompetence. North Am 1991;71:1111-34. Br J Urol 1979;51:497-9. Versi E. Descrinimant analysis of urethral pressure profilometry data 4d Stanton SL, Cardozo LD. Results of the colposuspension operation for diagnosis of genuine stress urinary incontinence. Br J Ob Gyn incontinence and prolapse. Br J Obstet Gynaecol 1979;86:693-7. 1990;97:251-59. Stanton SL, Cardozo LD. Surgical treatment of incontinence in elderly Vesey SG, Rivett A, O’Boyle PJ. Teflon injection in female stress inconti- women. Surg Gynecol Obstet 1980;150:555-7. nence. Effect on urethral pressure profile and flow rate. Br J Urol Stanton SL, Cardozo L, Williams JE, Ritchie D, Allan V. Clinical and uro- 1988;62:39-41. dynamic features of failed incontinence surgery in the female. Obstet Vicente J, Arano P. Endoscopic injection of Teflon for incontinence in Gynecol 1978;51:515-20. women (French). J Urol (Paris) 1984;90:35-8. Stanton SL, Hertogs K, Cox C, Hilton P, Cardozo L. Colposuspension Vierhout ME, Mulder AFP. De novo detrusor instability after Burch col- operation for genuine stress incontinence, a five-year study. Proceedings posuspension. Acta Obstet Gynecol Scand 1992;71:414-6. of the XII Annual Meeting of the International Continence Society Viljoen AC. The vaginal strips sling operation. An alternative procedure 1982;12:94-6. for urinary incontinence. S Afr Med J 1990;77:632-4. Stanton SL, Hilton P, Norton C, Cardozo L. Clinical and urodynamic Vordermark JS, Brannen GE, Wettlaufer JN, Modarelli RO. Suprapubic effects of anterior colporrhaphy and vaginal hysterectomy for prolapse endoscopic vesical neck suspension. J Urol 1979;122:165-7. with and without incontinence. Br J Obstet Gynaecol 1982;89:459-63. Walker GT, Texter JH Jr. Success and patient satisfaction following the Stanton SL, Williams JE, Ritchie D. The colposuspension operation for Stamey procedure for stress urinary incontinence. J Urol urinary incontinence. Br J Obstet Gynaecol 1976;83:890-5. 1992;147:1521-3. Steel SA, Cox C, Stanton SL. Long-term follow-up of detrusor instability Walter S, Hald T, Buhl J, Astrup A, Nordling J. Recurrent urinary inconti- following the colposuspension operation. Br J Urol 1985;58:138-42. nence treated with quite another type of prolapse operation. Eur Urol Stein M, Weinberg JJ. Polytetrafluoroethylene vs. polypropylene suture 1979;5:149-50. for endoscopic bladder neck suspension. Urology 1991;38:119-22. Walter S, Olesen KP, Hald T, Jensen HK, Pedersen PH. Urodynamic eval- Stephenson TP, Stone AR, Sheppard J, Sabur RY. Preliminary results of uation after vaginal repair and colposuspension. Br J Urol 1982;54:377- AS 791/792 artificial sphincter for urinary incontinence. Br J Urol 80. 1983;55:684-6. Webster GD, Kreder KJ. Voiding dysfunction following cystourethropexy: Stoeckel W. Uber die verwendung der musculi pyramidalis bei der orep its evaluation and management. J Urol 1990;144:670-3. beha der incontnientia urinae. Zentralbl Gynakol 1917; 41:11. Webster GD, Perez LM, Khoury JM, Timmons SL. Management of type Stricker P, Haylen B. Injectable collagen for type 3 female stress inconti- III stress urinary incontinence using artificial urinary sphincter. Urology nence: the first 50 Australian patients. Med J Aust 1993;158:89-91. 1992;39:499-503. Sundin T, Pettersson S. Anterior urethropexy according to Lapides in Wesolowski S. Results of the treatment of stress incontinence in women. stress urinary incontinence. A follow-up study.Scand J Urol Nephrol Br J Urol 1965;37:687-9. 1975;9:28-31. Wharton LR Jr, Telinde RW. An evaluation of fascial sling operation for Swami KS, Abrams P. Artificial urinary sphincters. Br J Hosp Med urinary incontinence in female patients. J Urol 1959;82:76-9. 1992;47:591-6. Wheelahan JB. Long-term results of colposuspension. Br J Urol Swierzewski SJ III, McGuire EJ. Pubovaginal sling for treatment of 1990;65:329-32. female stress urinary incontinence complicated by urethral diverticulum. Wheeler JS Jr, Culkin DJ, O’Hara RJ, Canning JR. Bladder dysfunction J Urol 1993;149:1012-4. and neurosyphilis. J Urol 1986;136:903-5. Symmonds RE. The suprapubic approach to anterior vaginal relaxation Wheeless CR Jr, Wharton LR, Dorsey JH, Telinde RW. The Goebell- and urinary stress incontinence. Clin Obstet Gynecol 1972;15:1107-21. Stoeckel operation for universal cases of urinary incontinence. Am J Szendrói Z, Sarlós J. A simplified surgical technique for the therapy of Obstet Gynecol 1977;128:546-9. stress incontinence. Int Urol Nephrol 1980;12:269-76. Williams E. The discussion on stress incontinence. Proc R Soc Med Tanagho EA. Colpocystourethropexy: the way we do it. J Urol 1947;40:361-70. 1976;116:751-3. Williams TJ, Telinde RW: The sling operation for urinary incontinence Tanagho EA, Smith DR. Clinical evaluation of a surgical technique for using mersilene ribbon. Obstet Gynecol 1962; 19:241. the correction of complete urinary incontinence. J Urol 1972;107:402- Wingo PA, Huezo CM, Rubin GL, Ory HW, Peterson HB. The mortality 11. risk associated with hysterectomy. Am J Obstet Gynecol 1985;152:803- Tanagho EA, Smith DR. Clinical evaluation of a surgical technique for 8. the correction of complete urinary incontinence. Trans Am Assoc Geni- Winter CC. Peripubic urethropexy for urinary stress incontinence in tourin Surg 1971;63:103-12. women. Urology 1982;20:408-11. Tattam A. Urodynamic discoveries. Nursing Standard 1987;2:22. Winter CC. Re: Review of an 8-year experience with modifications of Tauber R. Urethrovesical suspension for female urinary incontinence: endoscopic suspension of the bladder neck for female stress urinary refinements of INCO needle. Obstet Gynecol 1970;36:795-9. incontinence . J Urol 1990;144:1481-2. Telinde RW. The urethral sling operation. Clin Obstet Gynecol Wiskind AK, Creighton SM, Stanton SL. The incidence of genital pro- 1963;6:206-19. lapse following the Burch colposuspension operation. Neurourology and Terzian P. Transpubic urethropexy. Obstet Gynecol 1969;34:458-9. Urodynamics 1991;10:453-4. Terzian P. Transpubic urethropexy—ultimate cure for stress incontinence Witherington R. Stress urinary incontinence: a practical protocol for Dx of urine? Obstet Gynecol 1965;26:898-902. and Tx. Geriatrics 1982;37:38-43,47. Thunedborg P, Fischer-Rasmussen W, Jensen SB. Stress urinary inconti- Woodside JR. Pubovaginal sling procedure for the management of urinary nence and posterior bladder suspension defects. Results of vaginal incontinence after urethral trauma in women. J Urol 1987;138:527-8. repair versus Burch colposuspension. Acta Obstet Gynecol Scand Wujanto R, O’Reilly PH. Stamey needle suspension for stress urinary 1990;69:55-9. incontinence. A prospective study of 40 patients. Br J Urol 1989;63:162- Timmons MC, Addison WA. Choice of operation for genuine stress incon- 4. tinence. Curr Opin Obstet Gynecol 1991;3:528-33. Zacharin RF. Abdominoperineal urethral suspension: a ten-year experi- Toan NN. Simplified urethrocystovaginal suspension as treatment for ence in the management of recurrent stress incontinence of urine. Obstet stress urinary incontinence. Am J Obstet Gynecol 1993;168:1642. Gynecol 1977;50:1-8. Truskett ID. Stress incontinence and the combined synchronous vaginal- Zacharin RF. Abdominoperineal urethral suspension in the management of abdominal operation in its management. Aust N Z J Obstet Gynaecol recurrent stress incontinence of urine—a 15-year experience. Obstet 1967;7:224-8. Gynecol 1983;62:644-54. van-Geelen JM, Theeuwes AGM, Eskes TKAB, Martin CB Jr. The clini- Zacharin RF, Hamilton NT. Pulsion enterocele: long-term results of an cal and urodynamic effects of anterior vaginal repair and Burch colpo- abdominoperineal technique. Obstet Gynecol 1980;55:141-8. suspension. Am J Obstet Gynecol 1988;159:137-44. Zecchi de Souza A. Stress incontinence of urine. Int Surg 1976;61:396- Van Rooyen AJL, Liebenberg HC. A clinical approach to urinary inconti- 402. nence in the female. Obstet Gynecol 1979;53:1-7. Zimmern PE, Hadley HR, Leach GE, Raz S. Transvaginal closure of the Varner RE. Retropubic long-needle suspension procedures for stress uri- bladder neck and placement of a suprapubic catheter for destroyed ure- nary incontinence. Am J Obstet Gynecol 1990;163:551- 7. thra after long-term indwelling catheterization. J Urol 1985;134:554-7.

Page 40 Copyright © 1997 American Urological Association, Inc. Copyright © 1997 American Urological Association, Inc. Page 41 Page 42 Copyright © 1997 American Urological Association, Inc. Copyright © 1997 American Urological Association, Inc. Page 43 Page 44 Copyright © 1997 American Urological Association, Inc. Copyright © 1997 American Urological Association, Inc. Page 45 Page 46 Copyright © 1997 American Urological Association, Inc. Copyright © 1997 American Urological Association, Inc. Page 47 Page 48 Copyright © 1997 American Urological Association, Inc. Copyright © 1997 American Urological Association, Inc. Page 49 Page 50 Copyright © 1997 American Urological Association, Inc. Copyright © 1997 American Urological Association, Inc. Page 51 Page 52 Copyright © 1997 American Urological Association, Inc. Copyright © 1997 American Urological Association, Inc. Page 53 Page 54 Copyright © 1997 American Urological Association, Inc. Copyright © 1997 American Urological Association, Inc. Page 55 Page 56 Copyright © 1997 American Urological Association, Inc. Copyright © 1997 American Urological Association, Inc. Page 57 Table A-2 Articles rejected by panel group review

Principal Reason Rejected Number Rejected Data duplicated or updated in another report 23 Review article without primary data 1 Abstract only 9 Unconventional treatment 4 Incomplete or unintelligible information 2 Case report 1 Data irrelevant to surgical treatment of female SUI 1 Concomitant vaginal surgery 1 Total: 42

Page 58 Copyright © 1997 American Urological Association, Inc. Copyright © 1997 American Urological Association, Inc. Page 59 Page 60 Copyright © 1997 American Urological Association, Inc. Appendix B – Comparative outcomes tables

Copyright © 1997 American Urological Association, Inc. Page 61 Page 62 Copyright © 1997 American Urological Association, Inc. Copyright © 1997 American Urological Association, Inc. Page 63 yed in Tables B-2 to B-5. Tables yed in . For transvaginal suspensions example, the Burch procedure tional procedure modifications. literature. the Other category. mall numbers of patient groups ue to reporting variances between references rather than real differ- ouping (Table B-4), the Kelly pli- ouping (Table ry). Finally, Table B-5 summarizes Table ry). Finally, Subgroupings of complications for the various individual procedures under each four major procedure groupings are displa The Other category in each of these tables contains combined procedures (see page 17 Chapter 2) as well a variety addi B-2), with some exceptions. For Rates of complications are generally similar between the types retropubic suspensions (Table Inconsistencies are due to s B-3), complication rates are also generally similar. For transvaginal suspension procedures (Table in reporting and older literature B-4) are generally low and reflect differences Complication rates for anterior repairs (Table in data reported are due to small sample size and older B-5 displays complication rates for sling procedures. Differences Table Analysis of individual procedures complications (Tables B-2 to B-5) complications (Tables procedures Analysis of individual B-2), the individual procedures are: Burch, MMK, Lapides, Paravaginal and Other Under the retropubic suspension grouping (Table For the anterior repair gr Raz, Gittes and Other. B-3), the individual procedures are: Pereyra, Modified Stamey, (Table Homologous Materials, Synthetic Materials and Other. Wall, Vaginal Abdominal Fascia, Fascia Lata, sling procedures: AAUA) contains a full listing of procedures in Papers (available from the Working technical supplement to this report, Evidence are d opinion, such differences appears to have a higher UTI rate (median 24%) than other retropubic procedures. In the panel’s studies and to small overall sample sizes. This is true of the transfusion rate for Pereyra (17%) and dysuria Stamey (41%). and/or patients. ences from the other procedure groupings. cation and Other are the only procedures listed (because of considerable variability in types catego

Page 64 Copyright © 1997 American Urological Association, Inc. Copyright © 1997 American Urological Association, Inc. Page 65 Page 66 Copyright © 1997 American Urological Association, Inc. Copyright © 1997 American Urological Association, Inc. Page 67 Appendix C – Descriptive analysis of urodynamic testing

Urodynamic investigation evaluates bladder and sphincteric function. Urodynamics are helpful when incontinence cannot be demonstrated by other techniques, in women who have undergone prior incontinence surgery or who have failed empiric therapies and in patients who have undergone radical pelvic surgery or who have neurologic disorders that may affect bladder function.

Cystometry Cystometry, the graphic representation of detrusor pressure related to bladder volume, is used to assess detrusor sensation, capacity, compliance and activity. Water cystometry is more physiologic than gas. Incontinence is easily demonstrated with liquid media, and ﬁlling with ﬂuid allows better estimation of bladder volume and compliance.

Leak point pressure The abdominal leak point pressure indicates the relationship between sphincteric function and the vesical or abdominal pressure that causes leakage. The lower the leak pressure, the more profound the sphincteric dysfunction. Low leak point pressure implies intrinsic sphincteric dysfunction, but further validation is required regarding reproducibility, variables affecting leak point pressure and standardization of technique. Leak point pressure is determined with the patient in the standing position. At a known bladder volume, the patient is asked to slowly execute the Valsalva maneuver until incontinence is documented. The leak pressure may then be repeated later in ﬁlling. Variables known to affect leak point pressures include pelvic prolapse (such as cystocele), size of catheter, bladder volume at which leak point pressure is determined and bladder compliance.

Urethral pressure profile Urethral function may also be evaluated with a urethral pressure profile that estimates functional urethral length and maximum urethral closure pressure. Reproducibility and variability in values are problematic with this testing methodology. Techniques describing pressure transmission ratios between bladder and urethra associated with increases in abdominal pressure have not shown applicability. There is no relationship between any urethral pressure profile parameter and patient continence data (wet or dry) or type of incontinence (Versi, 1990).

Pressure/flow evaluation The simultaneous measurement of bladder pressure and urinary flow rate allows the recognition of urinary outflow obstruction that occurs in some women after incontinence surgery.

Videourodynamics (VUDS) Videourodynamic testing provides simultaneous functional and anatomic evaluation of the lower urinary tract. Recognition of pressure-related vesicoureteral reflux, outlet obstruction and urethral anatomy during bladder filling are advantages of this modality. Synchronous measurement and display of urodynamic parameters associated with radiographic visual- ization of the lower tract is the most accurate tool for evaluating dysfunction of the bladder and urethra. The status of the bladder neck and proximal urethra can be assessed at rest and with stress maneuvers, and their location in relation to the symphysis pubis can be determined. In obstructed patients, the location of urethral obstruction can be visually detected and compared with pressure/flow changes.

A Diagnostic evaluation, 1-2, 6, 13-15, 27, 30- Outcomes Abdominal complications, 24-25 31 definition and description of, 2, 3, 10, 12, Abdominoperineal resection of rectum Dysuria, as complication, 25 18, 22 tables, 19-20 as cause of ISD, 2, 14, 30 E Acute cholecystitis, 24-25 Overflow incontinence, 13 Enterocele, 1, 13, 14, 16, 30 Acute gastric dilatation, 25 P Age of patient, 3, 8, 23, 30 Enuresis, 13 Aldridge procedure, 17 Estrogen, loss of as factor in SUI, 13 Pad test, 6, 14, 27, 30, 31 Pain, as complication, 16, 25 Anterior repairs F and cure/dry rate, 3, 7, 23, 28 Parkinson’s disease, 14 FAST*PRO meta-analysis software, 8, 11, 18 and days in the hospital, 3, 24 Patient Fibrosis, 16 as option for treatment, 2, 7, 28 expectations from treatment, 5, 6, 14, 27 Fistulas, 25 complications of, 16 index patient, 4, 27 Functional electrical stimulation, 2, 15 description of, 16-17 informing of, 5, 6, 27-28 treatment, 6, 7 postoperative urgency and DI, 23 G Artificial sphincters, 2, 17, 22 Pelvic floor exercises, 2, 15 Gittes procedure, 16 Pelvic organ prolapse, see Prolapse; see also Autologous sling materials, 4, 17, 25 Goebell procedure, 17 Cystocele, Enterocele, Uterine prolapse, Gravitational loss of urine, 1, 13 Vault prolapse B Pereyra procedure, 16 Ball procedure, 16 H Perforation of bladder and urethral as com- Ball-Burch procedure (combined), 17 Hematuria, 15, 27 plication, 16 Biofeedback, 2, 15 Homologous sling materials, 4, 17, 25 Peripheral nerve injury, as complication, 4, Bladder complications, 25 Hospital stay, 3, 6, 24, 28 24 Bladder stones, 1, 13 Hypermobility, see Urethral hypermobility Pharmacologic therapy, 2, 15, 30 Bleeding as complication, 25 Hysterectomy, 2, 4, 14, 23, 24 Physical examination, 6, 14-15, 27, 30-31 Bowel injury, as complication, 4, 16, 24 Postvoid residual urine volume, 14 Bulbocavernous reflex, 14, 30 I Prolapse, 1, 4, 14, 16, 24, 27, 30 Burch procedure, 15, 22 Index patient, definition of and criteria for, 4, Pyridium™, 31 27 C Infection, 4, 6, 11, 13, 15, 24, 25, 27 R Cantor procedure (combined), 17 Ingelman-Sundberg procedure, 16 Raz suspension, 16 Cardiovascular complications, 25 Injectable agents, 2, 17, 22 Rectocele, 1, 13, 14, 30 Cobb-Ragde technique, 16 Insert devices, 2, 15 Retention, see Urinary retention Combined surgical procedures, 16, 17 Intrinsic sphincteric deficiency (ISD), 1-2, 3, Retropubic suspensions Continuous incontinence, 13 6, 13-14, 15, 17, 23, 26, 27, 31 and cure/dry rate, 3, 7, 23, 28 Cooper’s ligament, 15 and urgency/urge incontinence, 23 Cotton swab test, 14, 30, 31 K and urinary retention, 3, 24 Cure/dry rate Kelly plication, 16 as option for treatment, 7, 28 and anterior repairs, 3, 7, 23, 28, Kennedy procedure, 16 complications of, 16 and follow-up time points, 2-3, 11, 22 description of, 15-16 and meta-analysis, 11,12, 22 L postoperative urgency and DI, 23 and retropubic suspensions, 3, 7, 23, 28 Laparoscopic Burch procedure, 22 and sling procedures, 3, 7, 23, 28 Lapides procedure, 15 S and transvaginal suspensions, 3, 7, 23, 28 Leak point pressure, 31 Sacral dermatomes, 14 description of, 2, 3, 4, 10, 22-23 Seroma, as complication of sling procedures, discussion of with patient, 6, 28 M 25 Cure/dry/improved rate Marshall, Marchetti and Krantz procedure, 2, Sexual dysfunction, as complication, 25 and meta-analysis, 3, 11, 12, 22, 23, 15 Sling procedures description of, 3, 23 Micturition diary, see Voiding history and cure/dry rate, 3, 7, 23, 28 discussion of with patient, 6, 28 Mixed incontinence, 1, 13 and ISD, 23 Cystocele, 1, 13, 14, 30 Multiple sclerosis, 14 and urinary retention, 3, 24 Cystoscopy , 16, 17 Myelodysplasia, 14 as option for treatment, 2, 7, 28 complications of, 17, 25 D N description of, 17 Dacron pledget, used in Stamey procedure, Neurologic disorders or disease, 1, 2, 13, 14 materials for, 4, 17, 25 16 Neurologic evaluation, 14, 30 postoperative urgency and DI, 23 Death, 4, 12, 24, 31 Nonsurgical therapies for SUI, 2, 6, 15 Stamey procedure, 7, 16, 28 Detrusor instability Stenosis, 16 in diagnosis, 5, 6, 15, 27, 31 O Stone formation, as complication, 25 postoperative, 3, 8, 16, 23 Obstruction, 1, 3, 4, 15, 16, 24 Stroke, 14

Copyright © 1997 American Urological Association, Inc. Page 71 Surgeon experience, 5, 7, 27, 28 complications of, 16 Urinary sphincters, artificial, 2, 17, 22 Surgical treatment description of, 16 Urinary tract infection (UTI) 4, 6, 11, 13, 15, goal of, 2, 15 postoperative urgency and DI, 23 24, 25, 27 overall effectiveness of, 4, 28 Urodynamic evaluation, 6, 14-15, 31 prior, as factor in SUI, 2, 3, 13, 14, 23, 30 U Uterine prolapse, 1, 13, 14, 30 Symphysis pubis, 16 Ureteral complications, 16, 25 Symptoms, types of incontinence, 13 Urethral erosion, 25 V Synthetic sling materials, 4, 17, 25 Urethral hypermobility, 1, 6, 13-14, 15, 26, Vaginal epithelial atrophy, 14 27, 31 Vaginal erosion, 25 T Urethral mucosal coaptation (atrophy) as Vaginal examination as part of diagnosis, 30 Teflon™, 10, 22 cause of ISD, 2, 14, 15, 17 Vaginal shortening, as complication, 16 Timed voiding, 2, 15 Urethrocele, 16, 30 Valsalva maneuver, 14, 15 Transfusions, as complication, 4, 24, 25 Urgency, and urge incontinence, see also Vascular injury, as complication, 4, 16, 24 Transient incontinence, 13 specific treatment methods Vault prolapse, 1, 13, 30 Transvaginal suspensions as symptom, 1, 13, 31 Voiding history or diary, 14, 27, 30 and cure/dry rate, 3, 7, 23, 28 description of, 13 and days in the hospital, 3, 24 postoperative, 3, 6, 8, 16, 17, 22, 23, 27 W and urinary retention, 3, 24 Urinalysis, 1, 5, 6, 15, 27 Wound complication, 24, 25 as option for treatment, 2, 7, 28 Urinary retention, 3, 16, 17, 22, 23-24, 31

Board of Directors (1997 – 1998)

Roy J. Correa, Jr., MD* Dennis J. Card, MD* Gerald Sufrin, MD* William R. Turner, Jr., MD* Joseph C. Cerny, MD* Robert S. Waldbaum, MD* Jack W. McAninch, MD Joseph N. Corriere, Jr., MD G. James Gallagher Martin I. Resnick, MD* H. Logan Holtgrewe, MD Melanie H. Younger Winston K. Mebust, MD* Lawrence W. Jones, MD* Brendan M. Fox, MD David L. McCullough, MD* *Voting member Thomas P. Ball, Jr. MD* Harry C. Miller, Jr., MD*

Practice Parameters, Guidelines and Standards Committee (1997 – 1998) Joseph W. Segura, MD, Chair Gerald P. Hoke, MD Joseph A. Smith, Jr., MD, Consultant Ian M. Thompson, Jr., MD, Vice Chair Stuart S. Howards, MD Datta C. Wagle, MD Rodney A. Appell, MD John D. McConnell, MD, Consultant Hanan Bell, PhD, Methodology Roy J. Correa, Jr., MD, Ex Officio Winston K. Mebust, MD, Ex Officio Consultant Roger R. Dmochowski, MD Sharron L. Mee, MD Curtis Colby, Medical Editor Jack S. Elder, MD Glenn M. Preminger, MD Consultant Thomas C. Fenter, MD, Consultant Martin I. Resnick, MD, Ex Officio Patrick M. Florer, Database John B. Forrest, MD Claus G. Roehrborn, MD, Facilitator Consultant Charles E. Hawtrey, MD, Consultant Linda D. Shortliffe, MD, Consultant

Health Policy Department Staff and Consultants

Suzanne Boland Pope Theresa Lincoln Scott Reid Guidelines Coordinator Health Policy Projects Clerk Government Relations Policy Analyst Julie Bowers Lisa Emmons Roger Woods Guidelines Assistant Health Policy Manager Government Relations Assistant Joyce Brown Tracy Kiely Randolph B. Fenninger Guidelines Assistant Health Policy Analyst Washington Liaison Kim Hagedorn Betty Wagner William Glitz Health Policy Projects Coordinator Health Policy Assistant Public Relations Consultant Robin Hudson Megan Cohen Health Policy Projects Assistant Government Relations Manager

This report on the Surgical Management of Female Stress Urinary Incontinence was developed by the Female Stress Urinary Incontinence Clinical Guidelines Panel of the American Urological Association, Inc. This report is intended to furnish to the skilled practitioner a consensus of clear principles and strategies for quality patient care, based on current professional literature, clinical experience, and expert opinion. It does not establish a fixed set of rules or define the legal standard of care, pre-empting physician judgment in individual cases. An attempt has been made to recommend a range of generally acceptable modalities of treatment, taking into account variations in resources and in patient needs and preferences. It is recommended that the practitioner articulate and document the basis for any significant deviation from these parameters. Finally, it is recognized that conformance with these guidelines cannot ensure a successful result. The parameters should not stifle innovation, but will, themselves, be updated and will change with both scientific knowledge and technological advances. Report on the Surgical Management of Female Stress Urinary Incontinence

American Urological Association, Inc. 1000 Corporate Boulevard Linthicum, Maryland 21090 June 1997

ISBN 0-9649702-3-6