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A randomised controlled trial comparing TVT TM , Pelvicol TM and autologous fascial slings for the treatment of stress urinary incontinence in women
Author(s) -
Guerrero KL,
Emery SJ,
Wareham K,
Ismail S,
Watkins A,
Lucas MG
Publication year - 2010
Publication title -
bjog: an international journal of obstetrics and gynaecology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.157
H-Index - 164
eISSN - 1471-0528
pISSN - 1470-0328
DOI - 10.1111/j.1471-0528.2010.02696.x
Subject(s) - medicine , urinary incontinence , surgery , stress incontinence , randomized controlled trial , sling (weapon) , urology , urinary system
Please cite this paper as: Guerrero K, Emery S, Wareham K, Ismail S, Watkins A, Lucas M. A randomised controlled trial comparing TVT TM , Pelvicol TM and autologous fascial slings for the treatment of stress urinary incontinence in women. BJOG 2010;117:1493–1503. Objective To compare TVT TM , Pelvicol TM and autologous fascial slings (AFSs). Design A multicentre randomised control trial. Setting Four units in the UK. Population Women requiring primary surgery for stress urinary incontinence (SUI). Methods A total of 201 women with urodynamically proven stress incontinence were randomised into three groups and assessed at baseline, 6 weeks, 6 months and 1 year. Main outcome measure The primary outcome was patient‐reported improvement rates. Secondary outcomes included operative complications/time, intermittent self‐catheterisation (ISC) and re‐operation rates. The quality‐of‐life tools used were the Bristol Female Lower Urinary Tract Symptoms (BFLUTS) and EuroQoL. Results Fifty women had a Pelvicol TM sling, 79 had AFSs and 72 had TVT TM . At 6 months the Pelvicol TM arm had poorer improvement rates (73%) than TVT TM (92%)/AFS (95%); P = 0.003. At 1 year only 61% of the Pelvicol TM slings remained as improved, versus 93% of TVTs and 90% of AFSs ( P < 0.001). Pelvicol TM has poorer dry rates (22%) than TVT TM (55%)/AFS (48%) ( P = 0.001) at 1 year; hence, the Pelvicol TM arm was suspended following interim analysis. There is no difference in the success rates between TVT TM and AFS. One in five women in the Pelvicol TM arm had further surgery for SUI by 1 year, but none required further surgery in the other arms. AFS took longer to do (54 minutes versus 35 minutes for TVT TM /36 minutes for Pelvicol TM ) and had higher ISC rates (9.9 versus 0% Pelvicol TM /TVT TM 1.5%). Hospital stay was shortest for TVT TM (2 days). Most BFLUTS domains showed improvement in all three arms. The improvement for women in the Pelvicol TM arm, however, was less than for women in the other arms in several key domains. Conclusions Pelvicol TM cannot be recommended for the management of SUI. TVT TM does not have greater efficacy than AFS, but does utilise fewer resources.