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Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence.
BMJ. 2002 Jul 13; 325(7355):67.BMJ

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.

Authors+Show Affiliations

Department of Obstetrics and Gynaecology, University of Newcastle upon Tyne.No affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

12114234

Citation

Ward, Karen, et al. "Prospective Multicentre Randomised Trial of Tension-free Vaginal Tape and Colposuspension as Primary Treatment for Stress Incontinence." BMJ (Clinical Research Ed.), vol. 325, no. 7355, 2002, p. 67.
Ward K, Hilton P, United Kingdom and Ireland Tension-free Vaginal Tape Trial Group. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ. 2002;325(7355):67.
Ward, K., & Hilton, P. (2002). Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ (Clinical Research Ed.), 325(7355), 67.
Ward K, Hilton P, United Kingdom and Ireland Tension-free Vaginal Tape Trial Group. Prospective Multicentre Randomised Trial of Tension-free Vaginal Tape and Colposuspension as Primary Treatment for Stress Incontinence. BMJ. 2002 Jul 13;325(7355):67. PubMed PMID: 12114234.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. AU - Ward,Karen, AU - Hilton,Paul, AU - ,, PY - 2002/7/13/pubmed PY - 2002/8/6/medline PY - 2002/7/13/entrez SP - 67 EP - 67 JF - BMJ (Clinical research ed.) JO - BMJ VL - 325 IS - 7355 N2 - 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. SN - 1756-1833 UR - https://www.unboundmedicine.com/medline/citation/12114234/Prospective_multicentre_randomised_trial_of_tension_free_vaginal_tape_and_colposuspension_as_primary_treatment_for_stress_incontinence_ DB - PRIME DP - Unbound Medicine ER -