Long‐term follow‐up of a multicentre randomised controlled trial comparing tension‐free vaginal tape, xenograft and autologous fascial slings for the treatment of stress urinary incontinence in women

Objective To compare the long-term outcomes of a tension-free vaginal tape (TVT; Gynecare™, Somerville, NJ, USA), autologous fascial sling (AFS) and xenograft sling (porcine dermis, Pelvicol™; Bard, Murray Hill, NJ, USA) in the management of female stress urinary incontinence (SUI). Patients and Methods A multicentre randomised controlled trial carried out in four UK centres from 2001 to 2006 involving 201 women requiring primary surgery for SUI. The women were randomly assigned to receive TVT, AFS or Pelvicol. The primary outcome was surgical success defined as ‘women reporting being completely ‘dry’ or ‘improved’ at the time of follow-up’. The secondary outcomes included ‘completely dry’ rates, changes in the Bristol Female Lower Urinary Tract Symptoms (BFLUTS) and EuroQoL EQ-5D questionnaire scores. Results In all, 162 (80.6%) women were available for follow-up with a median (range) duration of 10 (6.6–12.6) years. ‘Success’ rates for TVT, AFS and Pelvicol were 73%, 75.4% and 58%, respectively. Comparing the 1- and 10-year ‘success’ rates, there was deterioration from 93% to 73% (P < 0.05) in the TVT arm and 90% to 75.4% (P < 0.05) in the AFS arm; ‘dry’ rates were 31.7%, 50.8% and 15.7%, respectively. Overall, the ‘dry’ rates favoured AFS when compared with Pelvicol (P < 0.001) and TVT (P = 0.036). The re-operation rate for persistent SUI was 3.2% (two patients) in the TVT arm, 13.1% (five) in the Pelvicol arm, while none of the patients in the AFS arm required further intervention. Conclusions Our study indicates there is not enough evidence to suggest a difference in long-term success rates between AFS and TVT. However, there is some evidence that ‘dry’ rates for AFS may be more durable than TVT.