Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)

Status Terminated

Clinical Trial Summary

This randomized multi-centre trial will recruit women with stress urinary incontinence who need surgical treatment for their condition. 300 women will be allocated either to receive a TVT Secur or a standard TVT surgical procedure. The main outcome is effectiveness of the procedure, determined using a 1-hour pad test (which tests for urine leakage) 12 months after surgery. The study will be carried out in 4 to 6 centers and will involve urogynaecologists, urologists and general obstetrician-gynaecologists: all clinicians will have received adequate training.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00685217
Study type	Interventional
Source	University of Calgary
Contact
Status	Terminated
Phase	Phase 3
Start date	May 2008
Completion date	April 2012

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See also
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