1. Overview of Surgical Management of SUI: Sling Selection, Outcomes, and Adverse Events Eric S. Rovner, M.D. Professor of Urology Medical University of South Carolina Charleston, South Carolina

2. Treatment Options for SUI WAWA Behavior –Pelvic floor exercises Drugs??? Pessary/Devices Surgical repair –Bulking agents

3. Prepubic sling

4. Which one ?? IF ALL WERE EQUIVALENT: -experience of surgeon -patient factors: -wishes and willingness to accept risks -other: convalescence, pain, etc BUT ALAS THEY ARE NOT ALL EQUIVALENT: -Operations are not…….. -efficacy, durability, recovery, etc. -Patients are not………... -types of SUI, anatomy, prior surgery, etc.

5. “I leak when I cough” Autologous Fascial Sling *Courtesy of Jerry G. Blaivas, MD Algorithm for surgical treatment of SUI*:

6. SURGERY for SUI 1995 Injectables (collagen) Abdominal (retropubic) suspensions - Burch -MMK -Richardson -etc. Vaginal -Needle suspensions (Raz, etc.) -Slings: fascia, synthetics, vaginal wall sling -Anterior colporraphy (Kelly plication) +/- Laparoscopy

7. Surgery for SUI: 2011 Midurethral Tapes –Transvaginal (TVT, etc.) “Minislings” –Suprapubic Commercial (SPARC, Uretex, etc.) Non-commercial “home made” versions –Raz ($10 TVT) –Rackley (PVT) –Transobturator Outside in/Inside out Injectables: Contigen, Durasphere, Macroplastique, Coaptite, etc RP suspensions: Burch, etc. Slings (bladder neck) x Needle BNS Anterior repair (Kelly)

8. ESR Operations to treat SUI (in 2011) Retropubic suspension (rarely) Injectables Autologous pubovaginal slings Vaginal tapes –Transobturator (outside in) –Retropubic

9. Why Not One Surgery for Everybody w/SUI? Patient variables in selecting surgery Prior failed SUI surgery –Erosion, extrusion, BOO, etc. –Retropubic (Burch, MMK, etc.) Physical examination –Anterior vaginal wall/urethral mobility –Prolapse –“extreme” habitus Urodynamics –Intrinsic urethral function (ISD) Urethral “disease” –Diverticulum, fistula, etc. Patient disease/morbidity –+/- vaginal atrophy (XRT, etc.) –Steroids –Immune status –Diabetes –Other

10. SUI Surgery 2011 Midurethral synthetic sling is a good choice…… EXCEPT……

11. SUI Exceptions Urethral diverticulum Urethrovaginal fistula Other urethral pathology (stricture) Severe irreversible atrophy or XRT Autologous pubovaginal sling

12. Other exceptions Unwilling or unable to have surgery: –Injectable Other RP surgery (w/o ISD) or can’t do lithotomy: –Burch

13. So, who gets which MUS? Midurethral sling –TOT –Retropubic –Mini-sling

14. transobturator vs. retropubic sling Do they work equally well for ISD???? - Low VLPP? -Poor urethral mobility ? Are they equally safe/effective in redo cases? - prior RP anti-incontinence surgery

15. Choice of Surgery for SUI Ideally Ideally….. –Evidence based Prospective, RCT’s –Equivalent inclusion/exclusion criteria –Uniform patient population for each subpopulation with SUI »Urodynamics, mobility, habitus, prior surgery, etc. –Factors: Efficacy, durability, cost, safety, convalescence, etc.

16. Choice of Surgery for SUI Reality……. –Non-evidenced based Poor quality literature –Commercial bias –Mostly anecdotal –Surgeon “preference”

17. AUA SUI Guidelines Update Reviewed SUI literature since last Guidelines and updated the document Dmochowski, et al, JU 183:1906, 2010

18. AUA SUI Guidelines Update 2010 Literature search 1994-2005* 436 papers suitable for efficacy/safety outcomes 155 papers only complications data usable Index patient: healthy female +/- prolapse willing to undergo surgical correction of SUI *AUA Best Practices update coming to include TOT

19. TOMUS N= 597 randomized to TOT or retropubic MUS Retropubic MUS= TVT (Gynecare) TOT= Monarc (AMS) or TVT-O (Gynecare) Outcomes Objective criteria Negative CST, negative 24 hour pad test, no re-Tx Subjective criteria No sx’s SUI, negative 3 d diary, no re-Tx Adverse events Null hypothesis: no difference = <12% between groups

20. Success Objective success 81% RP 78% TOT Subjective success 62% RP 56% TOT

21. “I am not certain why humans or animals are continent of urine and feces and I am not convinced that anyone really knows.” –J. Berry, 1961 (Berry Prosthesis)

22. Rx of Urinary Incontinence Continence= urethral closure forces > bladder expulsion forces Bladder Urethra All therapies either ↑ urethral or ↓ bladder forces

23. Rovners algorithm for SUI Surgery This is my approach –Mostly NON-EVIDENCE-BASED* Literature can be cited where available *to the extent of the quality of evidence in the literature to support any approach

24. Rovner’s Algorithm Assumptions: Patient is “index” patient –Has SUI, is healthy, desires surgical Rx, etc. –No XRT/fistula/UD –Can get into lithotomy position Patient willing to have any approach Surgeon equally skilled in all approaches No prolapse > Stage II No detrusor abnormalities –Compliance, etc.

25. Index patient w/ SUI Prior surgery? YesNo Obstructed? NoYes Urethrolysis +/- PVS Mobility? YesNo Prior RP surgery? Yes No TOT Low “pressure” urethra? Yes PVS (+/- RP UT) No TOT, or RP UT or PVS Urethrolysis +/- PVS (or RP UT)

26. Index patient w/ SUI Prior surgery? YesNo Mobility? Yes No RP UT (+/- PVS) Low “pressure” urethra? RP UT Or TOT RP UT (+/- PVS) H o o r a y ! ! ! ! ! ! !

27. The “perfect” therapy for SUI* Effective (high immediate success rate) Durable Simple, fast and easy to perform (reproducible) Applicable for ALL types of SUI –And all patients with SUI (primary and redo cases, body habitus, etc.) For Surgery: minimally invasive –Local (or no) anesthesia –Small (or no) incisions –Outpatient procedure –Short convalescence and return to normal activities –Minimal (or no) pain Low (or no) morbidity and complications Inexpensive: patient, healthcare facility, healthcare system, etc *theoretical

28. The Perfect Result (“Cure”) Dry (pad test, per patient, PE, etc) Resolution of all voiding sx’s No new voiding symptoms No pain Minimal utilization of resources –eg, cost, convalescence, LOS, etc Patient is ecstatic (QoL, questionnaire, etc) No complications –eg, fistula, prolapse, dyspareunia, UTIs, etc Permanently