Trials / Unknown
UnknownNCT01115465
Study of Macroplastique Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence
Real-time Observation of Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 276 (actual)
- Sponsor
- Uroplasty, Inc · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The ROSE Registry will determine the long-term safety and effectiveness of Macroplastique in the treatment of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).
Detailed description
The Rose Registry is a five-year post-market study of the safety and effectiveness of Macroplastique in the treatment of female stress urinary incontinence due to intrinsic sphincter deficiency.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Macroplastique | Macroplastique is an injectable soft-tissue bulking agent used to treat stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD). |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2021-12-01
- Completion
- 2022-02-01
- First posted
- 2010-05-04
- Last updated
- 2020-03-11
Locations
19 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01115465. Inclusion in this directory is not an endorsement.