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1 Sears, Roebuck & Co Slings for Stress Incontinence: Which One Best? Donna Y. Deng UCSF Department of Urology Stress Incontinence Surgery: Historical Perspectives Retropubic Suspensions (MMK, Burch) 1

2 Stress Incontinence Surgery: Historical Perspectives Stress Incontinence Surgery: Historical Perspectives Needle Suspensions (Stamey, Raz) Autologous Rectus Fascia Pubovaginal Sling Stress Incontinence Surgery Retropubic Midurethral Sling Retropubic Midurethral Mesh Sling ( TVT, SPARC ) SPARC 1996 (Ulmsten) > 1 million slings performed worldwide 80-90% success Blind passage through retropubic space 2

3 Suburethral Sling Pubovaginal sling Autologous fascia Other materials Tension-free synthetic sling Retropubic (TVT, SPARC ) Transobturator (Obtape, Monarc, TVT-O) Cochrane Database of Systematic Reviews Traditional suburethral sling operations for urinary incontinence in women (2005) abdominal + vaginal approach w/ autologous or synthetic material (pubovaginal) compared with other management options randomized or quasi-randomized trials 13 trials 5 trials PVS vs. Burch/MMK No difference in cure More wound complications after colposuspension PVS = Pubovaginal Sling Cochrane Review Summary Scientific quality of the trials poor Data too few Can t address comparison adequately No significant difference between Burch and Pubovaginal sling No significant difference between different materials (except infection) 3

4 Burch vs. Autologous PVS Burch has been gold standard Urinary Incontinence Treatment Network (UITN) 1st Multicenter randomized control trial 655 patients w/ 24 months follow-up PVS = pubovaginal sling Burch vs. Fascial Sling Burch Sling Age BMI Vaginal Deliveries > Previous incontinence surgery 15 Albo ME, Richter HE, Brubaker L et al. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med 2007; 356: Burch vs. Fascial Sling Adverse Events Burch Sling Ureteral injury 2 0 Ureterovaginal fistula 1 0 Cystotomy 10 2 Voiding dysfxn --> surgical revision 0 20 Serious adverse events 10% 13% Adverse events 47% 63% UTI Albo ME, Richter HE, Brubaker L et al. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med 2007; 356: Burch vs. Fascial Sling Burch Sling Overall Success Rate 38% 47% Success specific to SUI 49% 66% Serious adverse events 10% 13% Adverse events (mostly UTI) 47% 63% Voiding dysfunction 2% 14% 47% (p=0.01) 66% (p<0.001) 63% (p<0.001) 14% (p<0.001) Satisfaction Rate 78% 86% (p=0.02) Albo ME, Richter HE, Brubaker L et al. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med 2007; 356:

5 Study TVT Ward* Abdel-Fattah* Nilsson Richter N F/U (mos) Cure 81% 88% 81% 91% Voiding dysfxn 0% 8.3% 0% 9.5% De novo urge NR 15% 6.3% NR Erosion NR NR 0% NR * Part of randomized trial TVT vs. Burch (5 year followup) Ward & Hilton British J Obstet Gyn 2007 Prospective, randomized UK & Ireland TVT Burch N F/U (mos) Cure 63% 70% No leak 39% 46% Satisfied 91% 90% Vault proplase 1.8% 7.5% The Same! Palma et al Int Urogynecol J 2005 Prospective TVT vs. TOT TVT TOT N F/U 18m 14m Bladder perf 3 (2.3%) 0 De novo urge 26 (20.6%) 10 (10%) Retention 4 (3.1%) 0 Infection 6 (4.7%) 1 (1%) Cure 116 (92%) 94 (94%) Fischer et al Euro Urol 2005 Retrospective TVT vs. TOT TVT TO N F/U >12m >12m Bladder perf 4.5% 0.5% De novo urge* 4% 0% (p=0.0024) Cath > 48hr 5.5% 0% Cure 76% 81% Satisfied 88% 91% 5

6 TVT vs. TOT Multicenter Randomized Control Trial TVT (Ulmsten) TOT (ObTape) Followup 31 months Porena et al. Eur Urol 2007: 52: TVT vs. TOT (RCT) TVT TOT Cure 71.4% 77.3% Dry + improved 90% 90.6% Persistent OAB 44% 24% De novo urge 14% 11% Complications Extrusion 0 3 Needle thru vaginal mucosa 0 4 Self cath % (p<0.053) Author/Journal Complications of TO Sling Pts/Tape Major Compl Vag Erosion Delorme et al Eur Urol 2004 Uratape De Tayrac et al 30 1 obturator hem 0 0 Am J Ob Gyn 2004 Uratape Blad Perf Costa et al urethral erosion 3 (1.6%) 3 (1.6%) Eur Urol 2004 Uratape Minaglia et al (5%) Urol 2004 ObTape Domingo et al 65 1 obturator abscess 9 (13.8%) 0 J Urol 2005 Uratape 43/Obtape 21 Spinosa & Dubuis (2.5%) 0 Eur J Ob Gyn 2005 ObTape Summary Autologous fascial sling better than Burch TVT durable (at 8 years f/u) Transobturator Short term success similar to retropubic Less major complications ReMUS vs ToMUS randomized clinical trial in progress in United States (TOMUS) Siegel A 30 1 obturator abscess 6 (20%) 0 Urol 2005 ObTape 6

7 The Next Generation TVT SECUR (Gynecare Ethicon) MiniArc (AMS) Thank You 7

8 FDA MAUDE Database Manufacturer and User Facility Device Experience MAUDE Physician self-reporting of device malfunction or complication FDA sends report and device lot numbers to manufacturer for evaluation TVT Vascular 32 (2 deaths) Bowel 33 (6 deaths) Bladder/ Urethral Injury Nerve Injury Abscess Sepsis Deaths SPARC TVT-0 OB-TAPE (1 death) (1 death) 8 death 1 death 1 death 3 Monarc 1 TO Sling Complications Benassi G et al Int urogynecol J 2007 Rafii A et al Obstet Gynecol 2006 Deffieux X et al Int Urogynecol J 2006 Agostini A et al Acta obstet Gynecol Scand Starkman JS et al Int urogynecol J 2007 Smith PP and Appell RA Int Urogynecol J 2007 Abscess formation Obturator abscess (3 cases) Prepubic & thigh abscess Thigh & psoas abscess Vesicovaginal fistula Bladder perforation Deng et al. Presentation and management of major complications of midurethral slings: Neurourol Urodyn

9 46yo woman Case 1/05 - hysterectomy/ap repair/to sling Greenish vaginal discharge postop 3/06 - excision of eroded sling 11/06 - severe R thigh & labial swelling, greater girth of R thigh, unable to abduct or adduct 9

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11 Case 2 50 yo woman TOT for stress urinary incontinence No improvement in leakage Heaviness in left leg Vaginal discharge Excision of eroded mesh in vagina (4 months) I&D of left ischiorectal abscess (9 months) 11

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