A randomised controlled trial comparing TVTTM, PelvicolTM and autologous fascial slings for the treatment of stress urinary incontinence in women

Objective To compare TVTTM, PelvicolTM 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 PelvicolTM sling, 79 had AFSs and 72 had TVTTM. At 6 months the PelvicolTM arm had poorer improvement rates (73%) than TVTTM (92%)/AFS (95%); P = 0.003. At 1 year only 61% of the PelvicolTM slings remained as improved, versus 93% of TVTs and 90% of AFSs (P < 0.001). PelvicolTM has poorer dry rates (22%) than TVTTM (55%)/AFS (48%) (P = 0.001) at 1 year; hence, the PelvicolTM arm was suspended following interim analysis. There is no difference in the success rates between TVTTM and AFS. One in five women in the PelvicolTM 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 TVTTM/36 minutes for PelvicolTM) and had higher ISC rates (9.9 versus 0% PelvicolTM/TVTTM 1.5%). Hospital stay was shortest for TVTTM (2 days). Most BFLUTS domains showed improvement in all three arms. The improvement for women in the PelvicolTM arm, however, was less than for women in the other arms in several key domains. Conclusions PelvicolTM cannot be recommended for the management of SUI. TVTTM does not have greater efficacy than AFS, but does utilise fewer resources.