Objective To compare the long-term outcomes of tension-free vaginal tape (TVT) and colposuspension as primary treatment for stress incontinence.
Study design Multicentre randomised controlled trial.
Setting Secondary and tertiary care gynaecology, urology and urogynaecology departments in 14 centres in the UK and Eire.
Population Women with urodynamically confirmed stress incontinence and who had previously failed to respond to conservative treatment were invited to participate.
Methods Three hundred and forty-four women were randomised; 175 to TVT and 169 to colposuspension. This paper reports the 5-year outcomes.
Main outcome measures The primary outcome at 5 years was a 1-hour perineal pad test; other outcomes included clinical examination, Short Form-36 (SF-36) health status and Bristol Female Lower Urinary Tract Symptoms (BFLUTS) questionnaires.
Results A negative 1-hour pad test was recorded in 58/72 (81%) women in the TVT group and 44/49 (90%) in the colposuspension group (P= 0.21, Fisher’s exact test) at 5 years. There was an increase in enterocoele and rectocele in the colposuspension group; three late tape complications were seen in the TVT group.
Conclusion This study did not detect a significant difference between TVT and colposuspension for the cure of stress incontinence at 5 years. The effect of both procedures on cure of incontinence and improvement in quality of life is maintained in the long term. Vault and posterior vaginal wall prolapse are seen more commonly after colposuspension. Tape erosion may occur several years after surgery.