Controversies and Complications in Pelvic Reconstructive Surgery (Didactic)

PROGRAM CHAIR Andrew I. Sokol, MD

Cheryl B. Iglesia, MD Charles R. Rardin, MD

Sponsored by AAGL Advancing Minimally Invasive Gynecology Worldwide

Professional Education Information

Target Audience Educational activities are developed to meet the needs of surgical gynecologists in practice and in training, as well as, other allied healthcare professionals in the field of gynecology.

Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The AAGL designates this live activity for a maximum of 3.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME.

Table of Contents

Course Description ...... 1

Disclosure ...... 3

What Does the FDA Advisory Mean for Me and My Practice? C.B. Iglesia ...... 4

Pelvic "Deconstructive" Surgery – How to Manage the Complications of Prolapse Repair Surgery C.R. Rardin ...... 11

Credentialing for New Technologies – What is the Best Way Forward? C.B. Iglesia ...... 15

Is Hysterectomy Necessary in Pelvic Floor Repair? C.R. Rardin ...... 19

Biologics in Prolapse Repair – Just a Bunch of Hocus-Pocus? C.B. Iglesia ...... 21

Back to the Future – Native Tissue Repairs for Apical Prolapse A.I. Sokol ...... 25

What Is the (F)utility of Urodynamics? C.R. Rardin ...... 31

Managing Sling Complications A.I. Sokol ...... 35

Cultural and Linguistics Competency ...... 43

PG 206 Controversies and Complications in Pelvic Reconstructive Surgery (Didactic)

Andrew I. Sokol, Chair Faculty: Cheryl B. Iglesia, Charles R. Rardin

Course Description

FDA advisories, mesh lawsuits, media coverage, oh my! This course reviews "hot button" issues facing pelvic reconstructive and minimally invasive surgeons today: credentialing for new procedures, the FDA mesh advisory, management of mesh complications, hysterectomy versus hysteropexy, apical support during hysterectomy, and the use of biologics in prolapse repair surgery. These issues will be debated by the panel and data will be presented supporting each side. Practical tips will be given for navigating the consent process, managing mesh complications, and performing uterine sparing apical support procedures. The state of evidence for the use of native tissues and biologics will also be reviewed.

Course Objectives

At the conclusion of this course, the participant will be able to: 1) Summarize the FDA mesh advisory; 2) implement an effective surgical consent process; 3) use what was learned to support the vault at the time of benign hysterectomy; 4) identify appropriate hysteropexy patients; 5) apply skills learned to identify and manage mesh complications; and 6) summarize current literature about the use of biologics in prolapse repair.

Course Outline

8:00 Welcome, Introductions and Course Overview A.I. Sokol

8:05 What Does the FDA Advisory Mean for Me and My Practice? C.B. Iglesia

8:30 Pelvic "Deconstructive" Surgery – How to Manage the Complications of Prolapse Repair Surgery C.R. Rardin

8:55 Credentialing for New Technologies – What is the Best Way Forward? C.B. Iglesia

9:20 Is Hysterectomy Necessary in Pelvic Floor Repair? C.R. Rardin

9:45 Questions & Answers All Faculty

9:55 Break

10:10 Biologics in Prolapse Repair – Just a Bunch of Hocus-Pocus? C.B. Iglesia

10:35 Back to the Future – Native Tissue Repairs for Apical Prolapse A.I. Sokol

11:00 What Is the (F)utility of Urodynamics? C.R. Rardin

1 11:25 Managing Sling Complications A.I. Sokol

11:50 Questions & Answers All Faculty

12:00 Course Evaluation

2 PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop and have no conflict of interest to disclose (in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* Viviane F. Connor Consultant: Conceptus Incorporated Frank D. Loffer, Executive Vice President/Medical Director, AAGL* Linda Michels, Executive Director, AAGL* Jonathan Solnik Other: Lecturer - Olympus, Lecturer - Karl Storz Endoscopy-America

SCIENTIFIC PROGRAM COMMITTEE Arnold P. Advincula Consultant: CooperSurgical, Ethicon Women's Health & Urology, Intuitve Surgical Other: Royalties - CooperSurgical Linda Bradley Grants/Research Support: Elsevier Consultant: Bayer Healthcare Corp., Conceptus Incorporated, Ferring Pharmaceuticals Speaker's Bureau: Bayer Healthcare Corp., Conceptus Incorporated, Ferring Pharm Keith Isaacson Consultant: Karl Storz Endoscopy Rosanne M. Kho Other: Honorarium - Ethicon Endo-Surgery C.Y. Liu* Javier Magrina* Ceana H. Nezhat Consultant: Intuitve Surgical, Lumenis, Karl Storz Endoscopy-America Speaker's Bureau: Conceptus Incorporated, Ethicon Women's Health & Urology William H. Parker Grants/Research Support: Ethicon Women's Health & Urology Consultant: Ethicon Women's Health & Urology Craig J. Sobolewski Consultant: Covidien, CareFusion, TransEnterix Stock Shareholder: TransEnterix Speaker's Bureau: Covidien, Abbott Laboratories Other: Proctor - Intuitve Surgical

FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Andrew I. Sokol* Cheryl B. Iglesia* Charles R. Rardin*

Asterisk (*) denotes no financial relationships to disclose.

3 Disclosure What does the FDA Advisory Mean for My Practice and Me? I have no financial relationships to disclose. Cheryl B. Iglesia, MD Director, FPMRS MedStar Washington Hospital Center Associate Professor, ObGyn and Urology Georgetown University School of Medicine

Objectives Evolution in Pelvic Reconstructive Surgery At the end of the presentation, the participant

Trocar-less Mini should be able to Mesh Systems Trocared Vaginal Mesh/ 1) SiSummarize outcomes and complicati ons Laparoscopic- Robotic SCOP associated with vaginal mesh for prolapse Uterosacral / Sacrospinous Fixation 2) List potential indications and alternatives for Abdominal Sacrocolpopexy

synthetic vaginal mesh for prolapse Colporraphy

Why all the fuss?

• Was marketing ahead of science?

• Does a vaginal incision matter?

• Are mesh attac hmen t poitints itt?important?

• What are the training/learning curve issues?

• Why is sacrocolpopexy unscrutinized?

4 Industry developments

• Some trocared mesh kits no longer available (Prolift EWHU and Avaulta Bard)

• SllSmaller profile trocar‐free mesh kits

• Sales down from nearly 79,500 kits sold in 2010

Upper pass sites Prolift® Vaginal Mesh

Pubic Symphysis

ANTERIOR POSTERIOR TOTAL

Coccyx Ischial tuberosity Ischiopubic ramus

Bard Avaulta Apical Mesh Fixation Points

5 Elevate Anterior California Jury Awards $5.5M

Multidistrict Litigation (MDL) pending

FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh FDA UPDATE Notification

• FDA has received over 1,000 reports* from 9 surgical mesh manufacturers on complications • Vaginal repair with mesh is main concern . Erosion – serious AEs are not rare – effectiveness not superior to traditional repair (possible . IfInfecti on exception for anterior repair) . Pain / dyspareunia – little known about long term implications . Urinary problems – safety and effectiveness in question . Recurrent prolapse . Bowel, bladder, blood vessel perforation *Included slings for SUI and mesh for POP www.fda.gov/cdrh/safety/102008-surgicalmesh.html July 2011

FDA Advisory 2011 FDA Informed Consent

• Obtain specialized training… • Be vigilant for potential adverse events … especially erosion and infection • Recognize that in most cases, POP can be treated • Watch for complications…esp. bowel, bladder and blood vessel successfully without mesh … perforations • Consider before placing surgical mesh: • IfInform patien ts tha t ilttiimplantation of surgilical mesh is permanent… – permanent implant • Inform patients about the potential for serious complications… including pain during sexual intercourse, scarring, and narrowing of the vaginal wall – at risk for requiring additional surgery in POP repair using surgical mesh. – removal of mesh may involve multiple surgeries

• Provide patients with a copy of the patient labeling from the – mesh placed abdominally may result in lower rates of mesh manufacturer… complications

6 522 Orders IUGA recommends surveillance on first 1000 cases • In January 2012, the FDA imposed a Section 522 Order on 40 manufacturers of tiltransvaginal mesh. • Mandate required companies to provide up to 3years of post‐market data on the safety and effectiveness of their devices.

Study N F/U (mo) Mesh Non‐ P Blinded COMPS Cure mesh RCT SyntheticCure Mesh POP Nguyen 75 12 87% ant 55% <.05 Single 5% Altman Trial ‐ Effectiveness 2008 blinded exposure Anterior Carey 139 12 81% ant 65.6% NS Non‐ 5.6% 2009 blinded exposure • Study success POPQ

Nieminen 202 36 87% ant 59% <.001 Non‐ 19% – 60.8% mesh vs. 34.5% non‐mesh (p<0.001) 2010 blinded exposure • No bulge symptoms Iglesia 65 9.7 40.6% all 29.6% NS Double 15.6% 2010 blinded exposure – 75.4% mesh vs. 62.1% non‐mesh (p=0.008)

Withagen 194 12 90.4% all 54.8% <.001 Non‐ 16.9% 2011 blinded exposure • No difference in prolapse QoL outcomes Altman 389 12 82% ant 47.5% .008 Non‐ 3.2% 2011 blinded intervene for exposure

Altman Trial ‐ Effectiveness Altman Trial ‐ AEs Anterior Anterior • Study success POPQ

• No difference in prolapse QoL outcomes

7 Graft Complications (Abed 2011) Altman Trial: Re‐surgery at 1‐yr Anterior • 110 studies reported on erosion 10.3% • Range was 0 –29.7% Non-Mesh Mesh (n=182) (n=186) • No difference in rate btw synthetic & biologic Repeat anterior 0.6% 2.7% • 7.8% wound granulation (16 studies) repair or SUI surgery Surgery for 0% 3.2%* • Dyspareunia 9.1% (70 studies) complication • Range 0 –67% Total 0.6% 5.9% (p <0.05) • No difference in rate btw synthetic & biologic *for mesh erosion

Effectiveness: Outcome Measures Composite Outcome Measures: New standard Most use study endpoint: • Absence of prolapse beyond hymen “ideal pelvic support” = POP‐Q stage 0 ‐ 1 – average number of symptoms increases when prolapse beyond (prolapse > 1 cm above hymen) hymen* • Improvement in prolapse Quality of Life (QoL) However….. • Re‐surgery for recurrence – not correlated with POP symptoms or patient assessment of improvement* • Absence of bulge symptoms – central anterior wall: interobserver variability 68% – most associated with patient assessment of improvement and greatest † agreement (kappa 0.35)† difference in prolapse QoL measures compared to other measures

*Barber Ob Gyn 2009 †Whiteside AJOG 2004 *Swift AJOG 2003 †Barber Ob Gyn 2009

Studies since UPDATE Studies since UPDATE

• Three arm RCT (n=99) of native tissue vs biologic vs • 3 year f/up of surgical intervention after 600 Prolift repairs 2005‐ * synthetic graft after two years of f/up 2009+ – Anatomic failure: native tissue 58%, biologic 46% graft , – 87% f/up median f/up 38 months (range 15‐63) mesh 18% (P=.002) – Re‐op rate 11.6%: 6.9% for SUI, 3.6% mesh‐related complications, 3% recurrent POP. – Composite failure: native tissue 13%, biologic 12% graft, • Sokol 1 year f/up of 65 pts higher re‐op rate for mesh* mesh 4% (P=. 28) – Symptomatic prolapse 1/26 (3.8%) of mesh and 3/33 (9.1%) of no – No difference in sexual fxn mesh (P=.62) – 14% mesh & 4% porcine erosions

Menefee et al. Obstet Gynecol Dec 2011 *Sokol et al AJOG Jan 2012 + Landsheere et al AJOG Jan 2012

8 DEBATE

MESH EXPOSURE VS PROLAPSE RECURRENCE

Serious Mesh Complications

Pain/Dyspareunia Visceral erosion/injury

Where do we go from here?

CONSIDER MESH USE:

• Recurrent Prolapse, especially anterior • Advanced Stage • CSCertain Situations: – Collagen deficiency – Contraindications to abdominal surgery • ***BE CAREFUL: pelvic pain

IUGA Recommendations

9 Some Tips for Surgical Mesh Kits Mesh tips

• Pre and postop estrogen use in menopausal women • Hydrodissection with thick dissection plane • Minimize size of incisions • Avoiding over‐trimming epithelium and T incisions • Avoid over‐tensioning of graft arms • Cystoscopy/ rectal exam mandatory

Final Words

• Learn/Master/ Offer Native Tissue Repairs

• If you are doin g Mesh Re pairs

– Track Outcomes: Objective, Subjective, QoL, re‐ surgery for complications and recurrence

– Enroll in National Mesh Registry once available

ReferencesReferences References Murphy M et al. Clinical Practice Guidelines on Vaginal GraftUse from SGS. Obstet Gynecol 2008; 112(5): 1123‐30 • Abed H, Rahn DD, Lowenstein L, Balk EM, Clemons JL, Rogers RG; Systematic Review Group of the Society of Gynecologic Surgeons. Incidence and Sung VW et al, Graft Use in Transvaginal Pelvic Organ Prolapse Repair. Obstet Gynecol 2008; management of graft erosion, wound granulation and dyspareunia following 112(5): 1131‐42 vaginal prolapse repair with graft. Int Urogynecol J. 2011 Jul;22(7):789‐98. Epub 2011 Mar 22. Review. Iglesia CB. Synthetic vaginal mesh for pelvic organ prolapse. Cur Opin Obstet Gynecol 23; 362‐365 • G. Willy Davila & Kaven Baessler & Michel Cosson & Linda Cardozo. Selection of Walter JE et al. Transvaginal mesh procedures for pelvic organ prolapse. JOGC 2011; 22:168‐ patients in whom vaginal graft use may be appropriate . Consensus of the 2nd 174 IUGA Grafts Roundtable: Optimizing Safety and Appropriateness of Graft Use in Transvaginal Pelvic Reconstructive Surgery. Int Urogynecol J (2012) 23 (Suppl FDA.gov website 1):S7–S14.

10 Pelvic Deconstructive Surgery  I have no financial relationships to Managing Iatrogenic Pelvic Floor Dysfunction disclose.disclose.

Charles R. Rardin, MD Associate Professor Alpert Medical School of Brown University Division of Urogynecology Women and Infants’ Hospital Providence, RI

Disclaimer It’s a new day and we have some new issues…

 Much of this talk is opinion, anecdote, or  Olsen 1997 food for thought  11% prolapse repair  29% recurrent repair  Speed of technological innovation is  New devices and materials accelerating  FDA revising its 510(k) process  Efficacy and safety data lag further behind  New procedures  Collective evidence about management of  Mesh implant complications is that much further behind  More new procedures  Mesh excision  New Terminology  “mesh cripple”

Scenario 1 Complication: Urinary Retention  Voiding Dysfunction  PostPost--midurethralmidurethral sling voiding dysfunction immediately postpost--opop  r/o hematoma  d/c with Foley 24-24-72 hrhr72  If pppatient still unable to void at 33--1010 days:  consider reopening site under local, place rightright--angleangle under mesh, and pull down slightly 55--10 mmmm10  Urethral dilation, downward retraction is to be avoided

11 Complication: Urinary Retention

 If beyond ~~1010 days  consider cutting mesh under local in midline after 2-2-44 weeks of catheterization  All cases of impaired emptying were completely resolved  irritative symptoms were resolved (30%) or improved (70%)(70%)  61% patients remained continent  26% were improved over baselinebaseline

CR Rardin, Obstet Gynecol 2002  13% had recurrence of stress incontinence

ScenarioScenario

 Mesh sling penetration or erosion into the bladderbladder

Scenario

 Mesh Erosion  NonNon--healinghealing at an incision  Vaginal bleeding or drainage  Bristles, pain or dyspareunia  Sinus tract or abscess  Vigilance!Vigilance!  Mesh precautions  EducationEducation

12 Know your materials

 Multifilaments, woven, nonnon--macroporousmacroporous materials (e.g., Mersilene) become chronically infected  Partial excision likely to result in recurrent problemsproblems  Changes in materials changes their behaviors

Surgical Management: Have an algorithm ErosionErosion

 If minimally symptomatic, soon after  If nonIf non--AmidAmid Type I: plan full excision surgery, and not extruding through the  Combined vaginal and laparoscopic if retropubic plane of the epithelium, try conservative: componentcomponent  If Type I – excise until normal tissue ingrowth  Topical estrogen  Cannot see or feel the distinction between mesh and  Topical antibiotics tissuetissue  “pelvic rest”  Then keep going a bit  Otherwise, or if persistent, “trim” once  Hydrodissection (dilute marcaine/epi)  If not resolved – to OR for more assertive  Delineates sinus tracts management  Makes tissue-tissue-meshmesh distinction easier  Decreases bleeding

Surgical Management: Surgical Management: Erosion, continued Pain or retraction

 Points of mesh fixation are usually to  Anticipate difficulty delineating the blame (especially when levators are used) meshmesh  Establish the goal (usually release of  Folds and kinks contribute to the erosion tension)tension)  Previous trimming make it difficult to find  Consider alternative routes everythingeverything  Paramedian vaginal incision, closer to the  Cystoscopy!!! affected area  Leave vaginal incision open to drain  Laparoscopic retropubic dissection may afford excellent access to the affected area, without the need to traverse scarred fields

13 ScenarioScenario

 TVH (only) for prolapse  Posthysterectomy vault prolapse  Receives anterior repair  Prolapse recurs; subsequent anterior repairrepair  Eventually, winds up with TVL of 3.5cm (but Aa and Ba are 0)

14 Disclosures Credentialing for new technologies: What is the best way forward? • IhI have no fi nanc ilial re ltilations hips to Cheryl B. Iglesia, MD disclose. Director, FPMRS MedStar Washington Hospital Center Associate Professor, ObGyn & Urology Georgetown University School of Medicine

Objectives Definition

• Credentials –a medical school diploma, certificate of attendance at a postgraduate course, specialty board certificate, or preceptor • Identify best practice guidelines for certification. Credentialing is the process of confirming applicant’s credentials. credtilidentialing • Surgical Competence – Competence is the minimum acceptable level of skill required to perform a surgical procedure. • List common issues associated with • Surgical privileging is the evaluation process conducted by the proctoring credentialing committee for granting applicant’s privileges. Proctoring is one component of this evaluation process.

Why learn new procedures?

• “I want to provide the best care for my patients.”

• “I want to remain competitive.”

• “I feel pressure from my hospital system.”

• “My patients are asking for this.”

• “Using the ROBOT/Single port/etc is Cool!”

15 What are the potential problems Conundrum with new technology? My older partners can teach me a She can teach • lot. us the latest Patients may be placed at undue risk things. • Surgeons may have increased liability

• A learning curve exists

• External regulatory bodies and the US Government may get involved

How are surgeons learning new So how can we do this safely? technologies now? 1. Assess the new procedure using evidence based • See one, do one, teach one? information—efficacy, safety and need • Weekend courses? 2. Offer education for surgeons to acquire the requisite • Requisite knowledge, surgical skills and knowledge and skills 3. Monitor outcomes experience—volume matters 4. Credential and privilege surgeons / teams • Simulation 5. Educate patients

AUGS Guideline for Vaginal Mesh

16 Prolift® Total Vaginal Mesh ACOG/AUGS Statement 1) undergo training specific to each device 2) have experience with reconstructive surgical procedures 3) understand pelvic anatomy Reserve transvaginal mesh use for: • recurrent prolapse (particularly of the anterior ANTERIOR POSTERIOR TOTAL compartment) • medical comorbidities that preclude more invasive procedures

AUGS Guidelines for Vaginal Mesh Surgeons

General knowledge documented by : • Demonstrate understanding of relevant pelvic anatomy • completing a fellowship training program in Urogynecology, Female Pelvic • Read the manufacturer’s instructions for use (IFU) Medicine and Reconstructive Surgery, or Female Urology or by completing adequate CME in pelvic anatomy and reconstructive pelvic surgery • Observe steps involved in procedure via animation, video, or live surgery • Undergo hdhands on experience… using simuldlated modldels, animal or Specific knowledge obtained by: cadaveric models or other • Surgeons who do not have documentation of prior training with transvaginal • Consider specific intraoperative /postoperative complications that may mesh prolapse procedure should be proctored on no fewer than 5 procedures or be unique to the or device and the steps necessary to manage those as many as is necessary to demonstrate that they can independently perform the complications specific procedure. • Be familiar with the requirements for adequate informed consent

Privileging recommendations Experienced Vaginal Mesh

• surgery for pelvic floor disorders represents >50% of their surgical Surgeons practice including a minimum of 30 surgical cases for pelvic organ • Continuing medical education in female pelvic prolapse annually reconstructive surgery • Demonstrate experience and privileges in non‐mesh vaginal repair of prolapse including anterior colporrhaphy, posterior colporrhaphy, and • A minimum of 30 surgical cases for pelvic organ prolapse vaginal colpopexy (eg, uterosacral or sacrospinous ligament fixation), and (any route, with or without transvaginal mesh) experience and privileges to perform intraoperative cystoscopy to • evaluate for bladder and ureteral integrity. Demonstrate experience and privileges in non‐mesh • Annual internal audits should be performed. [REGISTRY pending] vaginal repair of prolapse, and experience and privileges to perform intraoperative cystoscopy

17 Experienced Surgeons (cont) Proctoring • Annual internal audits should be performed • Prior to adoption of a new transvaginal mesh • Impartially monitor, regulate, or oversee, surgical privileging for its technolgy or device, should be proctored on no medical staff • The surgical proctor does not establish a patient/physician relationship fewer than 5 procedures or as many as is • Teleproctoring may be the most cost effective necessary to demonstrate that they can • The surgical proctor is under no obligation to intervene

independently perform the newly adopted • The length/number of procedures governed by institutional bylaws procedure. • A confidential written report submission to the institution’s credentialing

REGISTRY

• BSUG BitihBritish SSitociety of UlUrogynecology

• US Pelvic Floor Disorders Registry (TBD)

References References (cont)

• Sachdeva AK et al. Safe Introduction of New Procedures and Emerging Technologies in Surgery: Education, Credentialing and Privilegin. Surg Oncol Clin • Guidelines for Providing Privileges and Credentials to N Am 2007; 16: 101‐114. • Guidelines for Providing Privileges and Credentials to Physicians for Transvaginal Physicians for Transvaginal Placement of Surgical Placement of Surgical Mesh for Pelvic Organ Prolapse. Female Pelvic Medicine & Mesh for Pelvic Organ Prolapse . American Reconstructive Surgery & Volume 18, Number 4, July/August 2012 • AUGS and ACOG Joint Committee Opinion on Vaginal Placement of Synthetic Urogynecologic Society’s Guidelines Development Mesh for POP. Available from: http://www.augs.org/p/bl/et/ blogid=3&blogaid=28. Committee (www.fpmrs.net) Female Pelvic Medicine • Satava, R. M. (1993). Proctors, preceptors, and laparoscopic surgery. The role of “proctor” in the surgical credentialing process. Surgical endoscopy, 7(4), 283–284. & Reconstructive Surgery & Volume 18, Number 4, July/August 2012

18 Disclosure Advances in the Management of  I have no financial relationships to Pelvic Organ Prolapse disclose.disclose.

Charles R. Rardin, MD Assistant Professor Brown Medical School/Women and Infants’ Hospital Of Rhode Island Division of Urogynecology Providence, RI

Hysterectomy – Hysterectomy for Prolapse? Evolution of Terminology  Hysterectomy (on its own) does not treat  Total Hysterectomy prolapseprolapse  Used to mean TAH/BSO   Now refers to uterus and cervix Hysterectomy is a risk factor for prolapse  TAH: 50% increased risk  SilHttSupracervical Hysterectomy  Supracervical: 100% increased risk  LAVH, LASH, TLH, TRH  TVH: 400% increased risk  Prophylactic salpingectomy (but not BSO)  (Altman D, Am J Obstet Gynecol 2008)  Uterine preservation  Traditional approach  Allows access to target tissues  Weight of uterus contributes to prolapse (??)

Treatment Options for Hysterectomy for Prolapse? Uterovaginal Prolapse

ProsPros ConsCons  Cohort of Stage III and IV uterovaginal prolapse  Traditional approach  Eliminates a portion of  3 groups:3 groups:  Eliminates certain future the procedure (with some risks (bleeding, of the highest risks)  TAH with ASC  Abdom ina l sacro hys teropexy endometrial cancer,  Reduces surgical impact  TAH with Uterosacral suspension cervical cancer if total  Allows retention of hysterectomy) nondiseased organs  No difference in failures between TAH/ASC and Sacrohysteropexy  Psychosocial considerations  TAH with non-non-meshmesh repairs had 6x increase in failure  Reduces complications associated with mesh Jeon MJ, Int Urogyn J 2007

19 Treatment Options for Treatment Options for Uterovaginal Prolapse Uterovaginal Prolapse

 Cohort of Grade 22--33 Uterovaginal Prolapse  Randomized trial of 66 women with Stage IIII--IVIV  TVH with sacrospinous vault fixation, vsvaginal uterovaginal prolapseprolapse sacrospinous hysteropexy  TVH with uterosacral suspension  Vaginal Sacrospinous hysteropexy  No significant differences in objective or  (repairs, slings as indicated) subjective failures in any compartment ((followupfollowup  Hysteropexy was favored for: at least 26 months)  Hospitalization  Favored Hysteropexy ((pp < .01):  Return to work activities  No difference in QOL or functional outcomes  Blood loss (198 v 402 cc)cc)402 Operative Time (59 v 91 min)min)91  Higher rates of recurrencerecurrence for hysteropexy if starting with Stage IVIVStage Maher CF, Int Urogyn J 2001 Dietz V, Int Urogyn J 2010

Variations on the Theme: Variations on the Theme: Hysteropexy with anterior and posterior mesh Transvaginal Mesh Hysteropexy - UpholdUphold

Conclusion

 Prolapse is an important issue that impacts quality of life in a burgeoning patient population  Failure rates are significant  New technologies offer reductions in failures, but itintro duce new issues  Patients and providers need to go through all these options (Hyst? Mesh? What Approach?), and understand the patient’s values  Stay tuned for prospective research!

20 BIOLOGICS in prolapse DisclosureDisclosure repair: just a bunch of hocushocus‐‐pocus?pocus? . I have no financial relationships to disclose.

Cheryl B. Iglesia, MD Section Director, FPMRS Washington Hospital Center Associate Professor, ObGyn and Urology Georgetown University School of Medicine

ObjectivesObjectives Clinical Implications for POP

. Describe options for biologics grafts The concept of graft use makes sense . List outcome data from biologic repairs 1. Connective tissue deficiencies 2. Prolapse may represent “vaginal hernias” 3. Level I data that use of mesh reduces the risk of recurrence of groin hernias between 50% and 75%

The ideal surgical material (Cumberland and Scales 1950)

Permanent Exposure Encapsulation Contraction Breakdown . Chemically and physically inert

. Non‐carcinogenic

. Ability to resist mechanical stress

. Easily attainable

. Sterilizable

. Affordable

****NO SUCH MATERIAL EXISTS!

21 Types of Materials

Autologous rectus fascia and fascia lata

Allografts cadaveric fascia lata and dermis

chemically processed fascia lata (Tutoplast) Xenografts porcine dermis small intestine submucosasubmucosa bovine pericardium

Synthetics absorbable ((polyglactinpolyglactin)) nonnon‐‐absorbable (polypropylene PPM) most common now: Type 1, pore size >75u

CrossCross‐‐linked biologic grafts

• Initially well tolerated • Rare exposure • May harden and shrink (encapsulate) • May distort anatomy • Modifications: meshing/making holes in it may make it softer; however limited data

Chemically Cross‐‐linked NonNon‐‐cross linked grafts e.g. PDA porcine dermis

. Pelvicol (SIS small intestine . Modifies collagen submucosa) structure to inhibit . Comprised of acellular degradation ECM . Decreases cellular . Permits cellular infiltration into graft infiltration, replaced by . Foreign body reaction patient‐derived collagen and encapsulation . Cross‐linking makes graft stiffer

22 Non cross‐‐linked grafts Concern with Biologics

. Concerning tensile properties (SIS, CFL) 7 months 14 months . Foreign body reactions (PDA)

. Documented autolysis . Freeze dried . Solvent dehydrated . HDA human dermal . PDA porcine dermal

Lessons learned from ASC

. Culligan et al 2005 AJOG . Polypropylene Mesh vs. Tutoplast . Cure rates: Mesh 91% Fascia 68%

. Deprest et al J Urol 2009 . Polypropylene mesh vs SIS small intestine submucosa . Xenograft more apical failures and reoperations

2008 SGS Systematic Review 2008 SGS Systematic Review (Sung VW et al Obstet Gynecol 2008;112:1131) 19501950‐‐20072007

1) Native tissue repair is appropriate compared with biologics for anterior compartment Posterior Compartment 2 RCTs (1 biologic, 1 absorbable) 2) Use o f bio log ic and synthe tic abbblbsorbable mesh in the Anterior Compartment 5 RCTs (1 biologic, 1 absorbable, 1 posterior compartment is not superior synthetic) 3) Synthetic mesh may be beneficial for anterior Multiple Compartment No RCTs compartment (apex posterior compartment have insufficient data)—but there are trade‐offs

23 Author Graft N Follow‐up Outcome Comps Faiiure Ba>‐ Current Status on Biologics 1 Meschia RCT 201 12 mos 7% graft Extrusion 2007 Anterior <1% Pelvicol vs. 19% no No mesh graft . Limited data on POP repair Natale 2009 RCT Ant 190 24 mos 28% Erosion Gynemesh Gynemesh 6.3% . Early breakdown may affect success vs. Ant Gynemesh Pelvicol 43.6% . Fewer mesh‐related complications compared with Pelvicol synthetics

. Modifications may improve tissue reactivity Menefee RCT 90 2 years 58% AR 14% mesh 2011 Anterior erosion . Outcomes depend on technique used for implantation repair vs. 18% Mesh Mesh vs. 4% porcine Biologic 46% Pelvicol erosion

P=sig

Unanswered Questions ReferencesReferences

Murphy M et al. Clinical Practice Guidelines on Vaginal GraftUse from SGS. Obstet Gynecol 2008; 112(5): 1123‐ . Reproducible results? 30

. Primary vs recurrent prolapse? Sung VW et al, Graft Use in Transvaginal Pelvic Organ Prolapse Repair. Obstet Gynecol 2008; 112(5): 1131 ‐42 . Dissection and implantation technique Iglesia CB. Synthetic vaginal mesh for pelvic organ . Effect on sexual function? prolapse. Cur Opin Obstet Gynecol 23; 362‐365

. Need more basic science: Walter JE et al. Transvaginal mesh procedures for pelvic . Ideal biologic organ prolapse. JOGC 2011; 22:168‐174 . Wound breakdown/metabolism FDA.gov website . Combination synthetic/biologic

24 Back to the Future - Disclosures Native Tissue Repairs for  I have no financial relationships to Apical Prolapse disclose.disclose.

Andrew I. Sokol, M.D. Associate Director, Minimally Invasive Surgery Section of FPMRS MedStar Washington Hospital Center Associate Professor of Ob/Gyn and Urology Georgetown University School of Medicine

Objectives Prolapse - Background

1.1. Review anatomy of apical support  16% of women in US have POP11 2.2. Summarize techniques/outcomes of  Lifetime prevalence 3030--50%50% vaginal repairs for apical prolapse:  2% syypypmptomatic22  McCall culdoplasty  7% lifetime risk of surgery for prolapse33  Uterosacral ligament suspension  Vault prolapse occurs after 1/200 (0.5%)  Sacrospinous ligament suspension hysterectomies  Iliococcygeus suspension

11Pannu et al, Radiographics 20(6):156720(6):1567--82;200082;2000 22Samuelsson EC et al, AJOG 180:299180:299--305;1999305;1999 33Olsen et al, Obstet Gynecol 89:501;1997

Risk Factors Delancey’s levels

 Level IILevel  Level IIIILevel  Things that disrupt support of uterus  McCall culdoplasty  Paravaginal repair and/or vagina  Uterosacral suspension  Anterior mesh procedures that use  Pregnancy/childbirth (vaginal > CC--section)*section)*  Sacrospinous suspension arcus onlyonlyarcus  ObesityObesity  Family history  Chronic cough or heavy lifting  Prior hysterectomy (especially if top of vagina not supported)

25 Goals of surgery for apical support – Level IILevel There are currently NO data  Establish continuity of anterior and posterior muscularis at apex supporting the use of

 Suspend vagina and restore posterior axis vaginal mesh or biologics

 Maintain vaginal length for APICAL prolapse repair

 RESTORE FUNCTION AND IMPROVE QOLQOL

QuestionsQuestions

1.1. Can this be prevented?

1.1. How can it be treated vaginally?vaginally? Prevention 1.1. Given controversy surrounding mesh and biologic implants, what other options can we offer?

McCall culdoplasty

 Surgical correction of enterocele and deep culcul--dede--sacsac during TVH

 Uterosacral ligaments plicated in midline, itilincorporating cul--dddee--sacsac peritoneum an d posterior vaginal cuff

 Closes redundant culcul--dede--sacsac and enterocele

 Provides apical support

 Lengthens vagina

26 McCall culdeplasty

McCall culdoplasty

AnteriorAnterior

McCall culdoplasty Complications: McCall’s culdeplasty

 Superior to uterosacral plication and simple peritoneal closure in prevention  Ureteral obstruction rate: of postpost--hysterectomyhysterectomy enterocele11  Up to 4.5% intraoperatively

 Easily visualized as unilateral lack of indigo carmine dye on cysto

 PERFORM CYSTOSCOPY!

11Cruikshank SH, KovacSR. RCT of three surgical methods used at the time of vaginal Hoffman MS et al, Ureteral obstruction from high McCall's culdeplastyculdeplasty.. J Gyn hysterectomy to prevent posterior enterocele.enterocele. AJOG 180:859180:859--65,1999.65,1999. Surg 16(3);119- 16(3);119-23, 2000.23, 2000.

27 Uterosacral ligament suspension (USLS)

TreatmentTreatment

USLS: Goals USLS: Helpful tips

 Reestablish continuity of pubocervical and rectovaginal muscularis  Pack with 2 or 3 laps  Elevate vault toward uterosacral ligaments  Long weighted speculum  Pull USL pedicle upup not out (Kochers)  Long Allis clamps  Highest stitch 4cm above spine (most medial)medial)  22--33 sutures per side

Uterosacral ligament suspension Complications: USLS

Patient Patient FollowFollow--upup Cure NumberNumber RateRate Jenkins 1997 50 66--2424 mos 100%  Ureteral obstruction rate:

 1 - 11% intraoperatively Webb 1998 693 1111--2222 mos 82%  90% resolved intraoperatively Shull 2000 289 22--66 yrs 87%  0.9% ureteral injury rate requiring further Barber 2000 46 16 mos 90% intervention

Karram 2001 202 22 mosmos22 95%  PERFORM CYSTOSCOPY!

Silva 20062006Silva 72 5 yrsyrs5 85%

GustiloGustilo--AshbyAshbyAM. Am J Obstet Gynecol 194:1478-194:1478-85, 2006.85, 2006.

28 Sacrospinous ligament fixation SSLF: Surgical Tips

 Enter R perirectal spacespace  Measure vagina  Must reach ligament  Anterior or posterior  Mark apex  Visualize/palpate CC--SSLSSL  Visualize ligament  Lighted suction/irrigator  Place 2 sutures >2cm medial to spine  Lighted retractor  Sew full thickness  Pass through apex vagina to ligament  Tie sutures  Capio device  Vagina directly opposed  Can use pulley stitch to CC--SSLSSL

Sacrospinous ligament fixation SSLF: Complications  Cure rates 80-80-94%94%  Complications:  Recurrence 6-6-35%35%  Buttock pain  20% anterior wall prolapse at 1 year  Nerve injury  Posterior deviation of vaginal axis  RtlijRectal injury Author Number Follow-up Cure rate  Vaginal stenosis Nichols (1982) 163 >2 yrs 97%  Stress incontinence Brown (1989) 11 8-21 mos 91%  Hemorrhage Elkins (1995) 14 3-6 mos 86%

Sze (1997) 75 7-72 mos 71% Morley G, DeLanceyJOL, AJOG 1988; 158:872158:872--8181

Comparison abdominal versus RCT: Bilateral SSLF vs ASC vaginal colpopexy

“Optimal” surgical result:  ASC vs unilateral SSF  29% of vaginal group  All USI received Burch  58% of abdominal group  FollowFollow--upup 2 yrs  ASC longgger OR time, higher cost, and slower Reoperation rate for recurrences: return to ADL  33% of vaginal group Objective Objective Subjective AnteriorAnterior PosteriorPosterior VaultVault  15% of abdominal group CureCure CureCure Recurrence Recurrence Recurrence

 Relative risk of “optimal effectiveness” abdominal vs ASC 76% 94% 7% 17% 4% vaginal 2.03 (1.22 - 9.83) SSLF 69% 91% 14% 7% 19%

Maher CF, et al. Abdominal sacral colpopexy or vaginal sacrospinous colpopexy for vaginal vault prolapse: A prospective Benson et el, Am J Obstet GynecolGynecol,, 1996 randomized study. Am J Obstet Gynecol 2004;190:202004;190:20--6.6.

29 Iliococcygeus vaginal vault suspension

 Posterior incision  Iliococcygeus exposed  BrieskyBriesky--NavartilNavartil retractors  Single delayed absorbable suture through levator muscle  11--2cm2cm caudad and posterior to spine  Both ends passed through posterior apex  Procedure repeated on opposite side

Meeks GR, et al. Am J Obstet Gynecol 171:1444171:1444--54,1994.54,1994.

Iliococcygeus vaginal vault Recommendations suspension

 McCall/USLS for all TVH (prophylactic)

 152 pts 1981 - 19931993  BrieskyBriesky--NavratilNavratil retractors  8% recurrence 6 wks - 5 yrs  USLS for primary prolapse repair  Sacrospinous fixation  2il2il2 apical recurrences  No enterocele or poor uterosacral ligaments  3 posterior recurrences  AdhesionsAdhesions  8 anterior recurrences  High posterior wall prolapse  Iliococcygeus suspension  Minimal apical prolapse  PERFORM CYSTOSCOPY! Meeks GR, et al. Am J Obstet Gynecol 171:1444171:1444--54,199454,1994

References References

1.1. Pannu, H. K., H. S. Kaufman, et al. (2000). "Dynamic MR imaging of pelvic organ prolapse: spectrum of abnormalities." Radiographics 2020(6): 1567-1567(6): -158158 8.8. Karram, M., S. Goldwasser, et al. (2001). "High uterosacral vaginal vault suspension with fascial 2.2. Samuelsson, E. C., F. T. Victor, et al. (1999). "Signs of genital prolapse in a Swedish reconstruction for vaginal repair of enterocele and vaginal vault prolapse." Am J Obstet Gynecol population of women 20 to 59 years of age and possible related factors." Am J Obstet 185185(6): 1339--1342;1339(6): 1342; discussion 13421342--13331333 GynecolGynecol 180180(2 Pt 1): 299299--305.305. 9.9. Silva, W. A., R. N. Pauls, et al. (2006). "Uterosacral ligament vault suspension: fivefive--yearyear 3.3. Olsen, A. L., V. J. Smith, et al. (1997). "Epidemiology of surgically managed pelvic outcomes." Obstet Gynecol 108108(2): 255-255(2): -263263 organ prolapse and urinary incontinence."incontinence." Obstet Gynecol 8989(4): 501501--506.Cruikshank506.Cruikshank 10.10. Morley, G. W. and J. O. DeLancey (1988). "Sacrospinous ligament fixation for eversion of the SH, Kovac SR. RCT of three surgical methods used at the time of vaginal vagina." Am J Obstet Gynecol 158(4): 872872--881881 hysterectomy to prevent posterior posterior enterocele. AJOG 1999;180:859 --6565 11.11. Nichols, D. H. (1982). "Sacrospinous fixation for massive eversion of the vagina." Am J Obstet GynecolGynecol 142142(7): 901-901(7): -904904 4.4. Hoffman MS et al, Ureteral obstruction from high McCall's culdeplasty. J Gyn Surg 12.12. Benson, J. T., V. Lucente, et al. (1996). "Vaginal versus abdominal reconstructive surgery for 2000;16(3);1192000;16(3);119--2323 the treatment of pelvic support defects: a prospective randomized study with longlong--termterm outcome 5.5. Webb, M. J., M. P. Aronson, et al. (1998). "Posthysterectomy vaginal vault prolapse: evaluation." Am J Obstet Gynecol 175(6): 14181418--1421;1421; discussion 14211421--14121412 primary repair in 693 patients." Obstet Gynecol 9292(2): 281281--285285 13.13. Maher CF, et al. Abdominal sacral colpopexy or vaginal sacrospinous colpopexy for vaginal 6.6. Shull, B. L., C. Bachofen, et al. (2000). "A transvaginal approach to repair of apical vault prolapse: A prospective randomized study. Am J Obstet Gynecol 2004;190:202004;190:20--6.6. and other associated sites of pelvic organ prolapse with uterosacral ligaments." Am J 14.14. Meeks, G. R., J. F. Washburne, et al. (1994). "Repair of vaginal vault prolapse by suspension of Obstet Gynecol 183183(6): 1365-1365(6): -1373;1373; discussion 1373-1373-13641364 the vagina to iliococcygeus (prespinous) fascia." Am J Obstet Gynecol 171171(6): 1444-1444(6): -1452;1452; discussion 14521452--1444.1444. 7.7. Barber, M. D., A. G. Visco, et al. (2000). "Bilateral uterosacral ligament vaginal vault 15.15. Sze, E. H. and M. M. Karram (1997). "Transvaginal repair of vault prolapse: a review." Obstet suspension with sitesite--specificspecific endopelvic fascia defect repair for treatment of pelvic GynecolGynecol 8989(3): 466-466(3): -475475 organ prolapse." Am J Obstet Gynecol 183183(6): 1402-1402(6): -1410;1410; discussion 1410-1410-14011401 8.8. GustiloGustilo--AshbyAshbyAM. Am J Obstet Gynecol 2006;194:1478-2006;194:1478-8585

30 DisclosureDisclosure Urodynamic Testing in the

Straightforward Patient:  I have no financial relationships to disclose Utility or Futility?

Charles R. Rardin, MD Associate Professor, OB/Gyn Director, Fellowship in Female Pelvic Medicine and Reconstructive Surgery Alpert Medical School of Brown University Director, Minimally Invasive and Robotic Surgery Women & Infants Hospital

Effects of Burch on Effects of Burch on PressurePressure--TransmissionTransmission Ratio PressurePressure--TransmissionTransmission Ratio

Proximal Urethra Distal Urethra Proximal Urethra Distal Urethra

Adapted from Hilton P, Stanton SL, Br J Obstet Gynaecol 1983 Adapted from Hilton P, Stanton SL, Br J Obstet Gynaecol 1983

Effects of Burch on PressurePressure--TransmissionTransmission Ratio “The Low Pressure Urethra as a Factor in Failed Retropubic Urethropexy”

 86 women with GSI  multichannel urodynamic testing  Burch colposuspension  54% failure rate if prepre--opop MUCP < 20  18% failure rate if prepre--opop MUCP > 20

Proximal Urethra Distal Urethra Sand PK et al. Obstet Gynecol 69:399, 1987

Adapted from Hilton P, Stanton SL, Br J Obstet Gynaecol 1983

31 1 Correlation of UCP and LPP Intrinsic Sphincter Deficiency

 Statistically significant (but clinically weak) correlation, history continous leakage with coefficients of 0.50.5--0.60.6 cystoscopy UVJ open at rest  Sultana 1995, Swift & Ostergard 1995 UPP MUCP < 20 cm H2O  NltiNo correlation LPP < 60 cm H2O  Bump 1995, McGuire 1995 < 90 cm (still >50% of pts with Grade III incontinence)  Empty Supine CST correlates with low LPP but not Q-tip variable UCPUCP PTR variable  McLennan & Bent, 1998

Do Urodynamic Indices predict TVT vs TOT: Differences between TVT and TOT? Randomized NoninferiorityTrial  60 patients with TVT (historical controls) compared  170 women with Urodynamic SUI randomized to TVT with 85 with TOT (Monarc) or TOT, with concurrent repairs as indicated (stratified  No significant differences between groups by presence of prolapse)  a cut--ooff poi nt of MUCP <42 cm H2O was ident ifie d  Primary outcome: abnormal bladder function as a predictor of failure in the overall group  Any subjective incontinence  Among these patients, TOT failure rate was 66--foldfold  Positive CST higher than TVT  ReoperationReoperation  RetentionRetention

Miller JR, Am J Obstet Gynecol 2006 Barber M, Obstet Gyncol 2007

TVT vs TOT: TVT vs TOT: Does it matter which sling? Randomized NoninferiorityTrial Can UDE help select?  Abnormal Bladder Function observed in 47% (TVT) and 43% (TOT)  Low leak point pressures and mean leak point  retention and reoperation appeared to favor TOT pressures were comparable  NNifiitfTOToninferiority of TOT was confi fidrmed  Urethral closure pressures or bladder neck hypermobility not presented  Presence of DO on urodynamics was an exclusion criterioncriterion

Barber M, Obstet Gyncol 2007 Barber M, Obstet Gyncol 2007

32 2 Retropubic vs Obturator SlingsSlings Does UrodynamicData in Patients with ISD Change Management Plans?  164 patients with ISD  39 real, abstracted cases  MUCP < 20 cm H2O  Read by 4 blinded Urogyn providers  Leak Point Pressure of <60 cm H2O  treatment plans developed  Randomized to receive TVT or TOT (((MonarcMonarc))  after washout period, cases rere--read,read, this time with  at 6 months, Urodynamic SUI was observed in:  21% of TVTTVT21% actual urodynamic data  45% of TOT  Significant changes in treatment plans:  9 reoperations for SUI in TOT group (zero in TVT)  27% medical27% medical  Projection: 1 in 6 patients with TOT would request reoperation  46% surgical46% surgical

Shierlitz, Obstet Gynecol 2009 Ward RM, Int Urogyn Journal, 2008

The Other Side of the Coin: VALUE Trial Provider blinded to UDE (TOMUS)  597 women randomized to TVT vsTOT  523 women with “uncomplicated” SUI (Pure SUI or SUI-SUI- predominant mixed incontinence), and no significant prolapse  Surgeons blinded to urodynamics results  Randomized to office evaluation with Urodynamic testing  Plan development versus office evaluation only  Sling p lacement and tensi oni ng  Negative stress test rate, 300cc at 12 months:  No significant differences in objective or subjective  69.4% in the UDE group failure ratesfailure rates  72.9% in the officeoffice--evaluationevaluation only group (NS)  TVT higher voiding dysfunction  70% reduction in the UDI score:  TOT slightly higher neurologic symptoms  77.2% in the UDE group  78.9% in the officeoffice--evaluationevaluation only group (NS) Richter HE, NEJM 2010 Nager CW, NEJM 2012

CARE Trial VALUE Trial Colpopexy and Urinary Reduction Efforts

 Sling types did not differ between groups  However, some patients in the UDE group had their planned sling type changed after UDE evaluation  WWwdwUSwssycvomen who underwent UDS were less likely to receive a diagnosis of OAB and more likely to receive a diagnosis of voidingvoiding--phasephase dysfunction  For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior (11%) to evaluation with urodynamictesting for outcomes at 1 year.

Nager CW, NEJM 2012 Brubaker, L., N Engl J Med 354;15 April 13, 2006

33 3 CARE Trial and UDS

•Women who demonstrated preoperative USI during prolapse reduction were more likely to report postoperative stress incontinence, regardless of concomitant colppposuspension (controls 58% vs. 3 8% (p = 0.04) and Burch 32% vs. 21% (p = 0.19))

Int Urogynecol J Pelvic Floor Dysfunct 2008 May;19(5) 607‐14. Epub 2008 Jan 9.

The OPUS Trial The OPUS Trial

•The vaginal equivalent of CARE Trial •At 12 months, UI (allowing for subsequent incontinence •322 of 337 randomized women (96%) completed 1‐year FU. treatment) was present in 27.3% and 43.0%, respectively (AOR 2.08, 95%CI 1.30 to 3.34). The number needed to treat with a •At 3 months, the rate of UI (or treatment) was 23.6% in the TVT TVT to prevent one case of urinary incontinence at 12 months group and 49.4% in the sham group (adjusted odds ratio (AOR) 3.22, was 6.3. 95%CI 1.99 to 5.22). •Rates of bladder perforations (6.7 vs 0%), UTI (31 vs 18.3%), major bleeding complications (3.1 vs 0%) and incomplete bladder emptying 6 weeks post‐operatively (3.7 vs 0%) were higher in the TVT group (all P<0.05).

Int Urogynecol J Pelvic Floor Dysfunct 2008 May;19(5) 607‐14. Epub 2008 Jan 9. Int Urogynecol J Pelvic Floor Dysfunct 2008 May;19(5) 607‐14. Epub 2008 Jan 9.

Conclusions

 Urodynamics may play a less important role than we thought as long as:  The patient has no OAB or DO, ISD, retention or prolapse  The surgeon is unlikely to change surgical plan anyway  However, the value of testing in terms of plan development, patient counseling, and new technology assessment should not be discarded

34 4 Managing sling Disclosures complications  I have no financial relationships to disclose.disclose. Andrew I. Sokol, M.D. AitDitMiillIiSAssociate Director, Minimally Invasive Surgery Section of FPMRS MedStar Washington Hospital Center Associate Professor of Ob/Gyn and Urology Georgetown University School of Medicine

Objectives AxiomsAxioms 1.1. MidMid--urethralurethral slings gold standard  Advantages vs BN slings 1.1. Review midmid--urethralurethral sling complications 2.2. Retropubic and transobturator slings have  MinorMinor similar effectiveness  MajorMajor  RP vs TOT trade--offoff 2.2. Discuss strategies to decrease  ↑ bladder injury and voiding dysfunction complication risk  ↓ groin pain  RP slings more effective for ISD11 3.3. Examine complication management 3.3. MiniMini--slingsling data lacking strategiesstrategies  Postop incontinence worse if minimini--slingsling fails22

11Schierlitz L, et al. Obstet Gynecol 2012;119:3212012;119:321--7.7. 22Barber MDBarber MD, et al. Obstet Gynecol 119:328119:328--37, 2012.37, 2012.

Surgical Procedures for SUI (2010) RP slingslingRP

Pubic NonNon--MeshMesh Symphysis Prolene Mesh 54,000 (21%) External Sling iliac a.

Obturator MidMid--urethralurethral slings 206,000 (79%)

a

r

h

t

e r Bladder

U

35 TOTTOT MiniMini--slingsslings

Top 10 sling complications reported to Sling complications FDAFDA Rank Adverse Events # of MDRs Percentile Rate 11PainPain 479479 34.9%34.9% “MINOR”“MINOR” MAJORMAJOR 22ErosionErosion 436 31.8%  Infection (UTI, wound)  Mesh erosion 3 Infection 260260 18.9%18.9% 4 Urinary problems 220 16.0%16.0%  Bladder perforation  Bowel perforation 55 Organ perforation 110110 883%83%.3%  Urinary retention  Nerve injury 6 Recurrence, Incontinence 103 7.5%7.5%  De novo DO  Vascular injury 6 Bleeding 103 7.5%7.5%  HematomaHematoma  DeathDeath 88 Dyspareunia 73 5.3%5.3% 99NeuroNeuro--muscularmuscular problems 50 3.6%3.6% 10 Vaginal scarring 22 1.6%1.6%

 Persistent FDA “signal” related to use of slings for SUI

Reported adverse events at followfollow--upup (sum of literature)

Range of Mean % Follow- Follow-upup (mos) ErosionErosion 0.25 --4.14.1 6 -48- 48 Reoperation 2.6 --6.26.2 6 -24- 24 “Minor complications” Dyspareunia 0.6 - 13.713.7 6 -60- 60 PainPain 1.6 - 22.222.2 6 -60- 60 Urinary problems 7.9 - 16.216.2 6 -60- 60 Infection*Infection* 4.8 - 27.427.4 6 -60- 60 * includes UTI

36 Bladder injury Tips to reduce cystotomyrisk

 00--23%23% of cases  Slow, controlled placement  Rates similar if TVT performed with  Hold trocar handle level to floor hyst or reconstructive procedures  Small proximal deviation causes large distal deviation  Hug pubic bone  Higher rate if prior incontinence surgerysurgery  CompletelyCompletely empty bladder before each pass  Catheter guide and retropubic hydrodissection? hydrodissection?  4.4% vs 2%11  ALWAYS CYSTO!!!

11Tamussino et al. Curr Opin Obstet Gynecol 2002;14:5152002;14:515--2020

Voiding dysfunction, retention, Now what?..... OABOAB

 Rates depend on definition used  ~5% inadequate voiding by 6 wks 111. ReplaceReplaceReplace trocartrocar  ~10% de novo OAB 2.2. Catheter x 3 days  If preop urgency, rule of thirds  1/3 better, 1/3 same, 1/3 worse

Sokol. AJOG 192(5):1537192(5):1537--43, 200543, 2005 KarramKarram.. Obstet Gynecol 101:929, 2003 HaabHaab.. Curr Opin Urol 11:293, 2001

PostPost--opop urgency Options to manage urinary retention

 Set expectations  Prolonged catheterization/ISC  Up to 10% after sling  >70% voiding dysfunction resolved by 6 wks11  Avoid overover--tighteningtightening  Urethral dilation  Rule out UTI, voiding dysfunction  Probablyyy not adeqqquate  Manage with behavioral modifications, PT and anticholinergics  Only 1/7 (14%) improved after dilation22  Consider UDS/UDS/cystocysto if persistent despite therapy  Sling division or urethrolysis  ErosionErosion  66--50%50% SUI recurrence after tape cut  De novo DO  Sling division if cannot be managed 1 Sokol. AJOG 2005;192:15372005;192:1537--4343 2 Rardin. AJOG 2002;100:8982002;100:898--202202

37 Tips for sling division

 If tight but no urethral erosion  Midline incision  Cut lateral to midline Major complications

ErosionsErosions Tips for urethral erosion

 0.30.3--23%23% for all slings  0.50.5--1.7%1.7% vaginal erosions after TVT  Management options  Recognize it!!!  Urethral erosions  High level of suspicion  Transurethral resection for urgency, frequency,  Tape excision with repair of urethrotomy or UTIs after sling  Bladd er eros ions  Transurethral resection  May be anterior if TOT  Suprapubic endoscopic resection  Dyed sling easier  Open cystotomy   Transvaginal resection Can inject dye for  Vaginal erosions urethral localization  Observation / estrogen  Local excision  OverOver--sewingsewing Clemens J et al. Urology 2000;56:5892000;56:589--9494 Meschia et al. IntUrogynecol J 2001;S2:S242001;S2:S24--2727

Inverted U-U-flapflap Sling dissection

38 Excision of mesh Layered urethral closure

Urethral integrity testing Closure of vaginal flap

Martius flap

Trattner catheter

Bowel Perforation Vascular complications: TVT

PREVENTION: .. Review prior operative notes  Finnish review of 1455 patients .. Trendelenburg  27 cases of EBL >200cc .. Direct needle along cephalad surface of pubic bone  27 retropubic hematomas INTERVENTION:  7 hematomas “outside retropubic area” .. Aggressively evaluate signs  1 (0.1%) major vessel injury (epigastric) or symptoms of peritonitis .. Imaging &/or exploration

Kuuva N, Nilsson C. Acta Obstet Gynecol Scand 2002;81:722002;81:72--7777

39 Relationship of TVT to vasculature Reasons RP sling trocar

Vessel Mean distance vessel to trocar deviation Superficial epigastric 3.9cm Inferior epigastric 3.9cm  Inexperience External iliac 4.9cm  Disorientation (drapes) Obturator 3.2cm  Patient movement  Lateral deviation to avoid bladder  Curve of lateral pubic ramus in cephalad directiondirection  lateral placement steers needle cephalad  Lack of control while piercing perineal membranemembrane  ObesityObesity  Trocar traverses labia majora in front of pubic bone

Muir et al. ObstetGynecol 2003;101(5):933- 2003;101(5):933-66 Muir. Obstet GynecolGynecol 2003;101(5):9332003;101(5):933--66

Retropubic hematomas Vascular Injury

INTERVENTION:  1010--12%12% have  MinorMinorvenousvenous bleeding hematomas >5cm after  Electrocautery or direct pressure using finger or TVTTVT packpack  If asymptomatic, manage  ModerateModerateModerate venous bleeding expectantly  30 cc balloon Foley filled to 50 cc for tamponade  Have low threshold of  Foley placed on traction and taped to medial thight suspicion if pain, for 1212--2424 hrs ecchymosis, or anemia  MajorMajor/arterial/arterial hemorrhage:  Explore rapidly expanding  IInitiatenitiate patient support hematomas for major  CConsideronsider open surgical intervention vs embolization vascular injury

TOT traverses active medial Areas of concern for TOT thigh muscles

 ISDISD   Neuropathic and muscular pain syndromes Adductor longus   Mesh exposure Adductor brevis  Vaginal perforation  Adduc tAddttor magnus  ErosionErosion  Obturator internis  Retropubic hematoma and externis  GracilisGracilis

40 Pain syndrome – obturator Obturator neuralgia neuralgia after TOT PREVENTION  Incidence unclear  Consider retropubic approach in very active patientspatients  Up to 12% longlong--termterm with pain issues*  Trocar insertion (or exit) close to bone  Shooting or sharp pain of affected groin; radiati on in var ie ty o f direc tions MANAGEMENT  Often delayed onset  PTPT  Exacerbated by activity; relieved with rest  AnalgesicsAnalgesics  May have vaginal and/or groin tenderness  Trigger point injections  Steroid (40 mg triamcinolone in 10cc lidocaine)  Sling excision Giberti, J Urol 2007

Penetrating the Sidewall ButtonButton--holehole management Erosion versus perforation?

1.1. Recognize it 2.2. Remove and replace slingsling 3.3. Close pppuncture sites 4.4. Alternatively, open epithelium b/w puncture sites, and overover--sewsew

Keys to complication MiniMini--slingsslings management  Limited data  Potential for officeoffice--basedbased 1.1. Proper preop decisiondecision--makingmaking and procedureprocedure consentconsent  Reports of:of:Reports 2.2. PreventionPrevention  ErosionsErosions  KtdthiKnow anatomy and technique  Bladder injury  Drain bladder  Obturator muscle bleeding  CYSTO ON ALL SLINGS  HematomaHematoma  Vaginal perforation 3.3. Recognize injury (high level of  FDA requesting postpost--marketmarket suspicion)suspicion) studiesstudies 4.4. Be able to manage own complications!

41 References References

1.1. Schierlitz L, Dwyer PL, Rosamilia A, et al. Three-Three-year follow-followyear -upup of tensiontension-- free vaginal tape compared with transobturator tape in women with stress 6.6. Muir TW, Tulikangas PK, Fidela Paraiso M, Walters MD. The relationship urinary incontinence and intrinsic sphincter deficiency. Obstet Gynecol of tension-tension-freefree vaginal tape insertion and the vascular anatomy. Obstet 2012;119(2 Pt 1):3211):321--7.7. Gynecol 2003;101:9332003;101:933--6.6. 2.2. Barber MD, Weidner A, Sokol AI, Amundsen CL, Jelovsek JE, Karram MM, 7.7. Kuuva N, Nilsson CG. A nationwide analysis of complications associated Ellerkman M, Rardin C, Iglesia CB, Toglia M for the Foundation for Female with the tensiontension--freefree vaginal tape (TVT) procedure. Acta Obstet Gynecol Health Awareness Research Network. SingleSingle--incisionincision mini-mini-slingsling compared Scand 2002;81:722002;81:72--7.7. with tension--free vaginal tape for the treatment of stress urinary incontinence. Obstet Gynecol 119 (2 Pt 1):3281):328--37, 2012.37, 2012. 8.8. Clemens JQ, DeLancey JO, Faerber GJ, Westney OL, McGuire EJ. Urinary tract erosions after synthetic pubovaginal slings: diagnosis and 3.3. Sokol AI, Jelovsek JE, Walters MD, Paraiso MF, Barber MD. Incidence and management strategy. Urology 2000;56:5892000;56:589--94.94. predictors of prolonged urinary retention after TVT with and without concurrent prolapse surgery. Am J Obstet Gynecol 2005;192:15372005;192:1537--43.43. 9.9. Rardin CR, Rosenblatt PL, Kohli N, Miklos JR, Heit M, Lucente VR. Release of tensiontension--freefree vaginal tape for the treatment of refractory 4.4. Karram MM, Segal JL, Vassallo BJ, Kleeman SD. Complications and postoperative voiding dysfunction. Obstet Gynecol 2002;100:8982002;100:898--902.902. untoward effects of the tensiontension--freefree vaginal tape procedure. Obstet Gynecol 2003;101:9292003;101:929--32.32. 10.10. Giberti C, Gallo F, Cortese P, Schenone M. Transobturator tape for treatment of female stress urinary incontinence: objective and subjective 5.5. Haab F, Traxer O, Ciofu C. TensionTension--freefree vaginal tape: why an unusual results after a mean followfollow--upup of two years. Urology 2007;69:7032007;69:703--7.7. concept is so successful. Curr Opin Urol 2001;11:2932001;11:293--7.7.

42 CULTURAL AND LINGUISTIC COMPETENCY

Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians (researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

US Population California Language Spoken at Home Language Spoken at Home

Spanish English Spanish

Indo-Euro English Indo-Euro Asian Other Asian

Other 19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the program, the importance of the services, and the resources available to the recipient, including the mix of oral and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies, including those which provide federal financial assistance, to examine the services they provide, identify any need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every California state agency which either provides information to, or has contact with, the public to provide bilingual interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

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If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills. A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

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