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 ; G ynecare™, S omerville, NJ , USA ), autologous fascial sling ( AFS ) and xenograft sling (porcine dermis, P elvicol™; B ard, M urray H ill, 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 P elvicol. 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 B ristol F emale L ower U rinary T ract S ymptoms ( BFLUTS ) and E uro Q o L EQ ‐5 D 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. ‘ S uccess’ rates for TVT , AFS and P elvicol 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 P elvicol ( 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 P elvicol 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 .