Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence

Abstract

Objective: To compare tension-free vaginal tape with colposuspension as primary treatment for stress incontinence.

Design: Multicentred randomised comparative trial.

Setting: Gynaecology or urology departments in 14 centres in the United Kingdom and Eire, including university teaching hospitals and district general hospitals.

Participants: 344 women with urodynamic stress incontinence; 175 randomised to tension-free vaginal tape and 169 to colposuspension

Main outcome measures: Assessment before treatment and at six months postoperatively with the SF-36, the Bristol female lower urinary tract symptoms questionnaire, the EQ-5D health questionnaire, a one week urinary diary, one hour perineal pad test, cystometry, and, in some centres, urethral profilometry.

Results: 23 women in the colposuspension group and 5 in the vaginal tape group withdrew before surgery. No significant difference was found between the groups for cure rates: 115 (66%) women in the vaginal tape group and 97 (57%) in the colposuspension group were objectively cured (95% confidence interval for difference in cure -4.7% to 21.3%). Bladder injury was more common during the vaginal tape procedure; postoperative complications, in particular delayed resumption of micturition, were more common after colposuspension. Operation time, duration of hospital stay, and return to normal activity were all longer after colposuspension than after the vaginal tape procedure.

Conclusion: Surgery with tension-free vaginal tape is associated with more operative complications than colposuspension, but colposuspension is associated with more postoperative complications and longer recovery. Vaginal tape shows promise for the treatment of urodynamic stress incontinence because of minimal access and rapid recovery times; cure rates at six months were comparable with colposuspension.

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Flow of participants through trial