Mohamed Abdel-Mohamed Abdel-FattahFattah

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Conflict Of Interest Lecturer for Astellas/ Pfizer/ Bard/ AMSResearch Grant Coloplast Consultant for Bard & AMSTravel sponsorship for medical conferences

from Astellas/ Pfizer/ Coloplast/ Ethicon

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No Shares!No Shares! No Effect on my ResearchNo Effect on my Research

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Retropubic from below

Retropubic from above

Transobturator ‘outside in’

Transobturator ‘inside out’

Quality of Evidence 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

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References: •Novara et al – Eur Urol 2010•Abdel-fattah et al- Eur Urol 2011/EJOG 2011•Angioli - Eur 2010/ TOMUS - NEJM 2011

Checked with:•4th ICI 2009•Cochrane Review 2008

Synthetic MUS = 2 Concepts : Synthetic MUS = 2 Concepts :

Tension Free Tension Free Vaginal Tapes = Vaginal Tapes = Standard MUSStandard MUS

Anchored Anchored Vaginal Tapes = Vaginal Tapes = Single Incision Single Incision Mid-urethral Mid-urethral Slings (SIMS)Slings (SIMS)Retropubic TVT

(RP-TVT)

Transobturator TVT (TO-TVT)

Inside-out TO-TVTOutside-in TO-TVT

New Concept? (traditional slings)

Anchoring Mechanism

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Standard Mid-urethral SlingsStandard Mid-urethral Slings11stst Gen: Retropubic TVT (RP-TVT) Gen: Retropubic TVT (RP-TVT)Gold Standard in UK BSUG surgical

database: > 65% of MUS. Vast majority performed

under GA Assassa et al 2010

11 Years Follow-up 77% success rate of those completed the follow-up.

Nilsson et al IUGJ 2008ERC/RCOG 2012

Standard Mid-urethral SlingsStandard Mid-urethral Slings22ndnd Gen: Transobturator TVT (TO-TVT) Gen: Transobturator TVT (TO-TVT)

Majority of MUS in USABSUG surgical

database: > 30% in UKGA Assassa et al Assassa et al

20102010

Objective cure rate at 4 years was 82.4%

Lipais et al, EJOG 2010Lipais et al, EJOG 2010

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

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RP-TVT vs. TO-TVT: RP-TVT vs. TO-TVT: ComplicationsComplications

^ RP-TVT ^ RP-TVT ^ TO-TVT ^ TO-TVT LUT injury or vaginal

perforations (OR: 2.5; 95% CI OR: 1.75–3.57; p < 0.0001)

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

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Long- Term FU Long- Term FU

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RCT: TO-TVT vs. RP –TVT RCT: TO-TVT vs. RP –TVT 5 Years Follow-up: - Patient reported success rate: 62% vs. 60% Patient reported success rate: 62% vs. 60% & & - Objective success 72.9% vs. 71.4% Objective success 72.9% vs. 71.4%

Systematic Reviews of RCTs with 12 m FU:Systematic Reviews of RCTs with 12 m FU:Lathe et BJUI 2010

Novara et al Eur 2010Abdel-fattah et al EJOG 2011

RCT –ETOT - 3 years follow-up RCT –ETOT - 3 years follow-up (n=238/341): (n=238/341): Patient-reported success rate: Patient-reported success rate: 73.1% with no significant difference between the 73.1% with no significant difference between the ‘Inside out’ and the outside–in techniques (73.18% ‘Inside out’ and the outside–in techniques (73.18% vs. 72.3%); OR, 0.927; 95%CI, 0.552-1.645;p=0.796) vs. 72.3%); OR, 0.927; 95%CI, 0.552-1.645;p=0.796) - - Pertained on sensitivity analysisPertained on sensitivity analysis

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SIMS vs. SMUS – Patient Reported Outcomes

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SIMS vs. SMUS – Objective Outcomes

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Operative Operative Time Time

Hospital Hospital

Stay Stay

Pain Scores Pain Scores @Day 1@Day 1

SIMS vs. SMUS – Conclusion SIMS – Inferior SIMS Better?

- Lower Patient-reported and objective cure rates at short term compared to SMUS: RR 0.83 95%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 - 8.67 minutes 95%CI -17.32, -0.02),

- Lower day-1 pain scores (WMD -1.74 95%CI -2.58, -0.09)

- Less post-operative groin pain (RR 0.18, 95%CI 0.04, 0.72ERC/RCOG 2012

√√ SMUS = RP-TVT / TO-TVT

XX Adjustable SIMS = Within properly conducted RCTs

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Systematic Review by Lathe et al No RCTs

Which Tape in Mixed UI?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

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RP-TVT vs. TO-TVT: RP-TVT vs. TO-TVT: ComplicationsComplications

^ RP-TVT ^ RP-TVT ^ TO-TVT ^ TO-TVT LUT injury or vaginal

perforations (OR: 2.5; 95% CI OR: 1.75–3.57; p < 0.0001)

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

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

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Systematic Review in Progress – SPFN & International collaboration - No RCTs

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MUS as secondary surgery at 12 MUS as secondary surgery at 12 m: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

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TO-TVT in recurrent SUITO-TVT in recurrent SUI

RP-TVT in RP-TVT in recurrent SUIrecurrent SUI

Biggs et alBiggs et al reported a reported a comparable 81% patient-comparable 81% patient-reported success rate in reported success rate in 27 women who 27 women who underwent TVT-Ounderwent TVT-O(TM) (TM)

Int Urogynecol J 2009

Similar results with the Similar results with the “outside-in” TOT were “outside-in” TOT were comparable to the 62.5% comparable to the 62.5% & 62% reported for TOT & 62% reported for TOT following failed MUS and following failed MUS and colposuspensioncolposuspension

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

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Canadian Guidelines Canadian Guidelines

In Women with combination of previous In Women with combination of previous continence surgery and intrinsic sphincter continence surgery and intrinsic sphincter deficiency : deficiency :

- - Autologous PV slings and low-tension RP- TVT Autologous PV slings and low-tension RP- TVT are considered more optimal proceduresare considered more optimal procedures:-More obstructive-Exert more urethral pressure at time of stress.

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

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My Conclusion RP-TVT & TO-TVT are the standard MUS RP-TVT & TO-TVT are the standard MUS

with no conclusive evidence to favour one with no conclusive evidence to favour one approach to the other in: approach to the other in:

Primary SUIPrimary MUI Recurrent SUI with no evidence of ISD

In Women with combination of In Women with combination of Recurrent SUI & ISD: Recurrent SUI & ISD: low-tension RP- TVT low-tension RP- TVT or Autologous PV slings.or Autologous PV slings.

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Incontinence procedures

1950 – 19901950 – 1990 stabilisation of urethrovesical junctionstabilisation of urethrovesical junctionbladder neck elevationbladder neck elevationBurch-colposuspension, MMK, facial slingBurch-colposuspension, MMK, facial sling

since 1990since 1990 minimal-invasiv midurethral slingsminimal-invasiv midurethral slingsretropubic route TVT°- slingretropubic route TVT°- sling1. Generation1. Generation

since 2003since 2003 indroduction transobturator routeindroduction transobturator routeTOT, TVT-O°TOT, TVT-O°2. Generation2. Generation

Ab 2006Ab 2006 introduction single-incision minislings introduction single-incision minislings TVT-Secur°, MiniArc°, Ajust°TVT-Secur°, MiniArc°, Ajust°3. Generation3. Generation