Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01893138|
Recruitment Status : Active, not recruiting
First Posted : July 8, 2013
Last Update Posted : January 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stress Urinary Incontinence||Biological: Roll-in Other: Placebo Biological: AMDC for USR||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||311 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence|
|Actual Study Start Date :||November 21, 2013|
|Actual Primary Completion Date :||October 9, 2019|
|Estimated Study Completion Date :||October 2020|
Roll-in patients are allowed in the study (up to 12 per site) and are randomized and treated exactly the same as standard study patients.
Placebo control is the vehicle solution used for the study product, AMDC for USR is the study product (autologous muscle derived cells for urinary sphincter repair).
|Placebo Comparator: Placebo||
Placebo control is the vehicle solution used for the study product.
|Experimental: AMDC for USR||
Biological: AMDC for USR
AMDC for USR is the study product (autologous muscle derived cells for urinary sphincter repair).
Other Name: Autologous muscle derived cells for urinary sphincter repair
- Number of leaks due to stress incontinence episodes, as recorded in a diary [ Time Frame: 12 months ]
- Stress leak frequency [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893138
|Principal Investigator:||Melissa Kaufman, M.D., Ph.D.||Vanderbilt University Medical Center, Department of Urologic Surgery|