Authors' objectives:

This review assesses the effectiveness and cost-effectiveness of tension-free vaginal tape (TVT) in comparison with other surgical procedures, particularly colposuspension, for the treatment of stress urinary incontinence in women.

Authors' recommendations: TVT is less invasive than colposuspension and traditional sling procedures. It is usually performed under regional or local anaesthesia rather than general anaesthesia, and is followed by a shorter stay in hospital. The principal operative complication is bladder perforation, occurring in around one in 25 procedures. This does not appear to carry any long-term risk provided that it is recognised at the time of the operation. Other traumatic injuries, such as to a major vessel or nerve, can occur but are rare. In the longer term, the main concern is complications associated with the use of the tape, particularly erosion into the vagina or urinary tract. Current evidence suggests that these occur only rarely, but it is too soon to judge this reliably. Most assessment has been in the form of description of case series. These show 2-year subjective cure rates (variously measured) of 7495%, with between 3 and 16% additional women improved but not cured. Only limited quality of life data are available from case series, but again they suggested significant improvement following TVT. The data from the case series must be treated with caution as bias may have been introduced because of the way in which cases were selected for inclusion and the lack of controls. Judging how well TVT performs in comparison with other surgical procedures for stress incontinence is difficult because there are few randomised controlled trials (RCTs). Confidence intervals (CIs) around the estimates are therefore wide. In comparison with open colposuspension, at 6 months and based on one trial involving 316 women, the estimated relative cure rate is 9% lower after TVT [relative risk (RR) 0.91; 95% CI 0.78 to 1.07] with an absolute difference of 6% (95% CI 17 to 5%). [Confidential information removed.] Differential withdrawals and losses to follow-up in the trial that contributes most of the data complicate interpretation. The conclusions depend on what assumptions are made about these women. Laparoscopic colposuspension and traditional slings have broadly similar cure rates to TVT and open colposuspension based on limited data from direct comparisons with TVT and from systematic reviews. Injectable agents appear to have lower cure rates. There are currently no RCT data beyond 2 years post-surgery. Although the case series with more than 4 years of follow-up suggest sustained cure rates, there are only three such studies, and they include only around 300 women. Long-term continence rates are therefore currently not known reliably, nor are the effects of TVT on the outcome of future problems such as prolapse and recurrent stress incontinence.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.hta.ac.uk/1307

Year Published: 2003

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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