Trials / Terminated
TerminatedNCT00685217
Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)
Tension-free Vaginal Tape Management of Stress Incontinence in Women: Randomized Trial of TVT Secur Versus TVT
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- University of Calgary · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | TVT Secur (Gynecare) | Sling device for stress urinary incontinence |
| PROCEDURE | TVT (Gynecare) | Sling procedure for stress urinary incontinence |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2011-03-01
- Completion
- 2012-04-01
- First posted
- 2008-05-28
- Last updated
- 2016-08-31
Locations
4 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT00685217. Inclusion in this directory is not an endorsement.