Authors' objectives:

The Association Franaise d'Urologie requested an assessment of the efficacy and safety of tension-free vaginal tape (TVT) and the economic impact of its use to treat isolated stress urinary incontinence (SUI) compared with the Burch colposuspension (BCS), the gold standard surgical procedure.

Authors' results and conclusions: Description. TVT is a surgical method of treatment for female SUI. It was introduced 5 years ago, and has developed very rapidly. An elastic polypropylene (Prolene) tape is inserted by the vaginal route to provide tension-free support for the middle part of the urethra. The aim is to recreate a pubourethral neoligament. Studies selected: - 13 clinical studies with a grade IV level of evidence, in which SUI was diagnosed objectively. Their external validity was poor. - 3 economic studies with a low level of design (measured by the Drummond criteria). Only one study gave details of the costs involved. The other 2 studies reported intermediate results. Efficacy on SUI. In the absence of any randomised controlled studies, it was only possible to compare TVT and BCS indirectly. The conclusions are therefore affected by a number of biases. - Short- and medium-term efficacy (5 years). Objective cure rates seem to be similar for TVT and BCS. Cure rates for TVT were in the range 86%-90% at 3 years, and 84.7% at 5 years. The cure rate for BCS was estimated as 84% at 4 years. - Long-term efficacy (> 5 years). In the absence of any data for TVT, it is not possible to estimate any possible reduction in cure rate, as can be seen for BCS. Peri- and post-operative observations. - Duration of the TVT procedure and of post-TVT urinary catheterisation seem to be shorter than those reported for BCS. - Hospital stay and time to resumption of activity seem to be shorter for patients treated by TVT. - There have been no reports of deaths related to the TVT procedure in the literature examined, while BCS-related mortality was 5/10 000. - The incidence of bladder perforation, bleeding, urinary infection and urinary retention were the same for both procedures, while the risk of blood transfusion was slightly higher for BCS.

Authors' recommendations: Clinical trials. In view of the problems involved in carrying out randomised controlled trials, given the rapid development of the technology, a cohort study should be conducted in a representative sample of patients undergoing TVT with annual follow-up over a period of 5 years. Development of indications. TVT seems to be an effective, safe and reproducible first-choice surgical treatment for isolated SUI and, in this indication, it is gradually replacing BCS. But it has also been proposed in indications that have not yet been validated (recurrence after traditional surgery for incontinence, presence of sphincter insufficiency or of mixed incontinence, combination of TVT and treatment for prolapse), which means that a further assessment is needed in 1 or 2 years' time. Standardisation of practice and costs. Data obtained from the PMSI (French computerised medical information system program) reveals discrepancies in how TVT is coded by different hospitals. Standardising practice would make it possible to interpret the diffusion of the method more accurately. Recognition of the method as a separate entity would also permit better management of the extra cost generated within hospital departments.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.has-sante.fr/

Year Published: 2002

URL for published report: n/a

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: France

Organisation Name: L'Agence Nationale d'Accreditation d'Evaluation en Santé

Contact Address: 2 avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex, France. Tel: +33 01 55 93 71 88; Fax: +33 01 55 93 74 35;

Contact Name: sh.leerobin@has-sante.fr

Contact Email: sh.leerobin@has-sante.fr

Copyright: <p>Agence Nationale pour le Developpement de l'Evaluation Medicale</p>