Trials / Completed
CompletedNCT01382602
Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study
A Double-blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Effectiveness of Cook MyoSite Incorporated AMDC in Female Patients With Stress Urinary Incontinence
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Cook MyoSite · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a clinical trial to study the safety and effectiveness of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of female stress urinary incontinence (SUI).
Detailed description
Study comparing intrasphincteric injection of AMDC-USR with placebo. Subjects unblinded after 12 months visits, but followed for 2 years. Subjects randomized to placebo could elect to receive open-label AMDC-USR after completing 12 months visit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AMDC-USR | AMDC-USR Treatment |
| BIOLOGICAL | Placebo | Placebo treatment |
Timeline
- Start date
- 2011-11-04
- Primary completion
- 2016-02-03
- Completion
- 2017-01-29
- First posted
- 2011-06-27
- Last updated
- 2018-05-17
- Results posted
- 2018-05-17
Locations
10 sites across 3 countries: Canada, Germany, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01382602. Inclusion in this directory is not an endorsement.