Transcript Dr.Mohamed Abdel Fattah - erc

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


No Shares!
No Effect on my Research
ERC/RCOG 2012
ERC/RCOG 2012
Retropubic
from above
Transobturator
‘inside out’
Transobturator
‘outside in’
Retropubic
from below
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G 2012
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:
•4th ICI 2009
•Cochrane Review 2008
Synthetic MUS = 2 Concepts :
Tension Free Vaginal
Tapes = Standard
MUS
 Retropubic TVT (RPTVT)
 Transobturator TVT
(TO-TVT)
Anchored Vaginal
Tapes = Single
Incision Midurethral Slings
(SIMS)
 New Concept? (traditional
slings)
 Anchoring Mechanism
Inside-out TO-TVT
Outside-in TO-TVT
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Standard Mid-urethral Slings
1st 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 2008
ERC/RCOG 2012
Standard Mid-urethral Slings
2nd Gen: Transobturator TVT (TO-TVT)
 Majority of MUS in USA
 BSUG surgical database:
> 30% in UK
GA
Assassa et al 2010
 Objective cure rate at 4
years was 82.4%
Lipais et al, EJOG 2010
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RP-TVT vs. TO-TVT:
12 RCTS: RP-TVT vs. Inside-out &
9 RCTs: RP-TVT vs. Outside-in &
1 RCT: comparing all three
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RP-TVT vs. TO-TVT: Overall Cure Rates
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RP-TVT vs. TO-TVT: Objective Outcome
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RP-TVT vs. TO-TVT: Patient - Reported
Outcome
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RP-TVT vs. TO-TVT: Quality of Life
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RP-TVT vs. TO-TVT: Re-operation
rates
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RP-TVT vs. TO-TVT: Complications
^ RP-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)
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^ TO-TVT
 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
Long- Term FU
RCT: TO-TVT vs. RP –TVT 5 Years Follow-up:
- Patient reported success rate: 62% vs. 60% &
- Objective success 72.9% vs. 71.4%
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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,
0.552-1.645;p=0.796) - Pertained 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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SIMS vs. SMUS –
Operative Details
Operative
Time
Hospital
Stay
Pain Scores
@Day 1
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SIMS vs. SMUS –
Conclusion
SIMS – Inferior
- 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.
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SIMS Better?
- 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, 0.72
√ SMUS = RP-TVT / TO-TVT
X Adjustable SIMS = Within
properly conducted RCTs
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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
 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)
ERC/RCOG 2012
^ TO-TVT
 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
√ 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
m:
Lipais et al 2010: RP-TVT 74%
(n=31)
Abdel-fattah at al 2010: TOTVT (n=46)
 70%; (55.6% for outside-in
TOT and 78.6% for insideout TVT-O)
 Multvariate Regression
Model: A low MUCP was the
only independent predictor
of failure
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TO-TVT in
recurrent SUI
 Biggs
et al reported a
comparable
81% patientreported success rate in 27
women who underwent TVTO(TM)
Int Urogynecol J 2009
RP-TVT in
recurrent SUI
 Best Body of Evidence
 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
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 Lo et al Urol 2002
 Moore et al Int Urogynecol J 2006
 Van-Baelen et al Urol Int 2009
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:
- 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 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.
ERC/RCOG 2012
Incontinence procedures
1950 – 1990 stabilisation of urethrovesical junction
bladder neck elevation
Burch-colposuspension, MMK, facial sling
since 1990
minimal-invasiv midurethral slings
retropubic route TVT°- sling
1. Generation
since 2003
indroduction transobturator route
TOT, TVT-O°
2. Generation
Ab 2006
introduction single-incision minislings
TVT-Secur°, MiniArc°, Ajust°
3. Generation