Trials / Completed
CompletedNCT00463554
TVT-SECUR A Pilot Study for the Treatment of Stress Urinary Incontinence
An Evaluation of the GYNECARE TVT-SECUR* System (Tension-free Support for Incontinence) for the Treatment of Stress Urinary Incontinence *Trademark
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 72 (actual)
- Sponsor
- Ethicon, Inc. · Industry
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to obtain clinical performance information on the GYNECARE TVT-SECUR\* System (Tension-free Support for Incontinence) in women with stress urinary incontinence (SUI).
Detailed description
The primary variable for effectiveness is \> 50% improvement on the subjective symptom Visual Analog Scale (VAS) at Visit 3/Week 5 (35 days post-surgery) to be accepted.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GYNECARE TVT-SECUR* System | A sub-urethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2007-01-01
- Completion
- 2007-12-01
- First posted
- 2007-04-20
- Last updated
- 2023-08-23
Locations
6 sites across 3 countries: United States, Finland, Italy
Source: ClinicalTrials.gov record NCT00463554. Inclusion in this directory is not an endorsement.