Mohamed Abdel-Fattah ERC-RCOG 2012

Conflict Of Interest Lecturer for Astellas/ Pfizer/ Bard/ AMS Research Grant Coloplast Consultant for Bard & AMS Travel sponsorship for medical conferences from Astellas/ Pfizer/ Coloplast/ Ethicon ERC/RCOG 2012 No Shares! No Shares! No Effect on my Research No Effect on my Research

ERC/RCOG 2012

Retropubic from below Retropubic from above Transobturator ‘outside in’ Transobturator ‘inside out’

Quality of Evidence RCTs are the gold standard in assessment of surgical interventions:  Adequately powered = proper sample size calculation  Low risk of Bias = adequate randomisation/ allocation concealment/ blinding Systematic reviews based on meta-analyses of randomised controlled trials (RCTs) are the cornerstone of evidence–based medicine; systematic reviews summarise the clinical evidence while meta-analyses provide summary estimates of the treatment effect ERC/RCOG 2012

References: Novara et al – Eur Urol 2010 Abdel-fattah et al- Eur Urol 2011/EJOG 2011 Angioli - Eur 2010/ TOMUS - NEJM 2011 Checked with: 4 th ICI 2009 Cochrane Review 2008

Synthetic MUS = 2 Concepts : Tension Free Vaginal Tapes = Standard MUS Anchored Vaginal Tapes = Single Incision Mid- urethral Slings (SIMS) Retropubic TVT (RP- TVT) Transobturator TVT (TO-TVT)  Inside-out TO-TVT  Outside-in TO-TVT New Concept? (traditional slings) Anchoring Mechanism ERC/RCOG 2012

Standard Mid-urethral Slings 1 st Gen: Retropubic TVT (RP-TVT) Gold Standard in UK BSUG surgical database:  > 65% of MUS.  Vast majority performed under GA Assassa et al Years Follow-up 77% success rate of those completed the follow-up. Nilsson et al IUGJ 2008 ERC/RCOG 2012

Standard Mid-urethral Slings 2 nd Gen: Transobturator TVT (TO-TVT) Majority of MUS in USA BSUG surgical database:  > 30% in UK Assassa et al 2010  GA Assassa et al 2010 Objective cure rate at 4 years was 82.4% Lipais et al, EJOG 2010 ERC/RCOG 2012

RP-TVT vs. TO-TVT: 12 RCTS: RP-TVT vs. Inside-out & 9 RCTs: RP-TVT vs. Outside-in & 1 RCT: comparing all three ERC/RCOG 2012

RP-TVT vs. TO-TVT: Overall Cure Rates ERC/RCOG 2012

RP-TVT vs. TO-TVT: Objective Outcome ERC/RCOG 2012

RP-TVT vs. TO-TVT: Patient - Reported Outcome ERC/RCOG 2012

RP-TVT vs. TO-TVT: Quality of Life ERC/RCOG 2012

RP-TVT vs. TO-TVT: Re-operation rates ERC/RCOG 2012

RP-TVT vs. TO-TVT: Complications ^ RP-TVT ^ TO-TVT LUT injury or vaginal perforations (OR: 2.5; 95% CI OR: 1.75–3.57; p < ) Postoperative hematoma (OR: 2.62; 95% CI OR: 1.35– 5.08; p = 0.005) Storage LUTS e.g. Urgency (OR: 1.35; 95% CI OR: 1.05– 1.72; p = 0.02) Vaginal erosion were slightly higher following TOT (OR: 0.64; 95% CI OR: 0.41–0.97; p = 0.04; Obtape©) Groin/ Thigh Pain – Latthe BJOG 2007/ Teo R J Urol 2010 ERC/RCOG 2012

Long- Term FU ERC/RCOG 2012 RCT: TO-TVT vs. RP –TVT RCT: TO-TVT vs. RP –TVT 5 Years Follow-up: - Patient reported success rate: 62% vs. 60% & - Objective success 72.9% vs. 71.4%

Systematic Reviews of RCTs with 12 m FU: Lathe et BJUI 2010 Novara et al Eur 2010 Abdel-fattah et al EJOG 2011 RCT –ETOT - 3 years follow-up (n=238/341): Patient-reported success rate: 73.1% with no significant difference between the ‘Inside out’ and the outside–in techniques (73.18% vs. 72.3%); OR, 0.927; 95%CI, ;p=0.796) - Pertained on sensitivity analysis ERC/RCOG 2012

SIMS vs. SMUS – Patient Reported Outcomes ERC/RCOG 2012

SIMS vs. SMUS – Objective Outcomes ERC/RCOG 2012

SIMS vs. SMUS – Operative Details ERC/RCOG 2012 Operative Time HospitalStay Pain 1

SIMS vs. SMUS – Conclusion SIMS – Inferior SIMS Better? - Lower Patient-reported and objective cure rates at short term compared to SMUS: RR %CI 0.70, 0.99 and RR 0.85, 95%CI 0.74, 0.97 respectively). - - Repeat continence surgery (RR 6.72, 95%CI 2.39, 18.89) and de novo urgency incontinence (RR 2.08, 95%CI 1.01, 4.28) were significantly higher. - Shorter operative time (WMD minutes 95%CI , -0.02), - Lower day-1 pain scores (WMD %CI -2.58, -0.09) - Less post-operative groin pain (RR 0.18, 95%CI 0.04, 0.72 ERC/RCOG 2012

√ √ SMUS = RP-TVT / TO-TVT X X Adjustable SIMS = Within properly conducted RCTs ERC/RCOG 2012

Systematic Review by Lathe et al No RCTs

Which Tape in Mixed UI? - 63% of women with urodynamic MUI experience complete resolution of urgency symptoms following RP -TVT (TM) - 47% & 92% objective cure of DO & urodynamic SUI respectively. Duckett et al (BJOG 2006) & (Int Urogynecol J 2010) Lee et al compared the cure rates at 1 & 6 years follow-up in women with urodynamic SUI and MUI who underwent RP - TVT (TM) and did not find any significant difference (94.1% vs. 84.1% and 89.8% vs. 79.4%, respectively). Korean J Urol 2010 Abdel-fattah et al reported 75% patient-reported success of TO-TVT at 12-month; with no significant difference from women with SUI in the same study. AMJOG 2011 ERC/RCOG 2012

RP-TVT vs. TO-TVT: Complications ^ RP-TVT ^ TO-TVT LUT injury or vaginal perforations (OR: 2.5; 95% CI OR: 1.75–3.57; p < ) Postoperative hematoma (OR: 2.62; 95% CI OR: 1.35– 5.08; p = 0.005) Storage LUTS e.g. Urgency (OR: 1.35; 95% CI OR: 1.05– 1.72; p = 0.02) Vaginal erosion were slightly higher following TOT (OR: 0.64; 95% CI OR: 0.41–0.97; p = 0.04; Obtape©) Groin/ Thigh Pain – J. Duckett presentation: Latthe BJOG 2007/ Teo R J Urol 2010 ERC/RCOG 2012

√ √ SMUS = RP-TVT / TO-TVT Possible Trend towards TO-TVT – no conclusive evidence ERC/RCOG 2012

Systematic Review in Progress – SPFN & International collaboration - No RCTs ERC/RCOG 2012

MUS as secondary surgery at 12 m: Lipais et al 2010: RP-TVT 74% (n=31) Abdel-fattah at al 2010: TO- TVT (n=46) 70%; 70%; (55.6% for outside-in TOT and 78.6% for inside- out TVT-O) Multvariate Regression Model: A low MUCP was the only independent predictor of failure ERC/RCOG 2012

TO-TVT in recurrent SUI RP-TVT in recurrent SUI Biggs et al reported a comparable 81% patient- reported success rate in 27 women who underwent TVT- O (TM) Biggs et al reported a comparable 81% patient- reported success rate in 27 women who underwent TVT- O (TM) Int Urogynecol J 2009 Similar results with the “outside-in” TOT were comparable to the 62.5% & 62% reported for TOT following failed MUS and colposuspension Similar results with the “outside-in” TOT were comparable to the 62.5% & 62% reported for TOT following failed MUS and colposuspension Lee et al J Urol 2007 Sivaslioglu et al Arch Obstet Gynecol 2010 Best Body of Evidence Best Body of Evidence Lo et al Lo et al Urol 2002 Moore et al Moore et al Int Urogynecol J 2006 Van-Baelen et al Van-Baelen et al Urol Int 2009 ERC/RCOG 2012

Canadian Guidelines In Women with combination of previous continence surgery and intrinsic sphincter deficiency : - Autologous PV slings and low-tension RP- TVT are considered more optimal procedures - Autologous PV slings and low-tension RP- TVT are considered more optimal procedures: - More obstructive - Exert more urethral pressure at time of stress. ERC/RCOG 2012

√ √ SMUS = RP-TVT / TO-TVT IF combined with ISD = RP-TVT ERC/RCOG 2012

My Conclusion RP-TVT & TO-TVT are the standard MUS with no conclusive evidence to favour one approach to the other in: RP-TVT & TO-TVT are the standard MUS with no conclusive evidence to favour one approach to the other in: Primary SUI Primary MUI Recurrent SUI with no evidence of ISD In Women with combination of Recurrent SUI & ISD: low-tension RP- TVT or Autologous PV slings. In Women with combination of Recurrent SUI & ISD: low-tension RP- TVT or Autologous PV slings. ERC/RCOG 2012

Incontinence procedures 1950 – 1990stabilisation of urethrovesical junction bladder neck elevation Burch-colposuspension, MMK, facial sling since 1990minimal-invasiv midurethral slings retropubic route TVT°- sling 1. Generation since 2003indroduction transobturator route TOT, TVT-O° 2. Generation Ab 2006introduction single-incision minislings TVT-Secur°, MiniArc°, Ajust° 3. Generation

Acknowledgement: Giants Petros & Ulmsten Delorme De-Leval ERC/RCOG 2012

Tape Material (Best Available Evidence) The Ideal tape Material: 1.Resist infection 2.Easily incorporate to the surrounding tissues 3.Must be histological well tolerated 4.Minimal post-insertion shrinkage 5.Have an optimal elasticity ERC/RCOG 2012

Host Response “Polypropylene” Mesh material: Accumulating evidence suggests usage of “Polypropylene”  producing the least inflammatory response;  allowing integration with host tissues Mon- filament / Macro-porous (>70um) Pore size ; Mono- Vs. Multi- filament: Mon- filament / Macro-porous (>70um) = Resist Infection ERC/RCOG 2012

Monofilament Macroporous = Resist Infection MACROPHAGE UM BACTERIA < 1UM LEUCOCYTE 9-15 UM ERC/RCOG 2012

Host Response “Polypropylene” Mesh material: Accumulating evidence suggests usage of “Polypropylene”  producing the least inflammatory response;  allowing integration with host tissues Mon- filament / Macro-porous (>70um) Pore size ; Mono- Vs. Multi- filament: Mon- filament / Macro-porous (>70um) = Resist Infection Weight & tensile strength, Elasticity: Tissue healing: patients’ intrinsic factors ERC/RCOG 2012

Synthetic Knitted Polypropylene Mono-filament Macro-porous (>70um) Light Weight Tested (FDA approval!) Tape Material (Best Available Evidence) The Ideal tape Material: 1.Resist infection 2.Easily incorporate to the surrounding tissues 3.Must be histological well tolerated 4.Minimal post-insertion shrinkage 5.Have an optimal elasticity ERC/RCOG 2012