Last updated on April 2020

Adaptive Design Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair

Brief description of study

This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) compared to a placebo in the treatment of stress urinary incontinence (SUI) in adult female patients. Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.

Detailed Study Description

Stress urinary incontinence (SUI) is the accidental loss of urine due to physical activity, such as laughing, coughing, or sneezing. Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) involves a medical procedure in which a participant's own muscle cells are collected, processed, and then injected into the tissues of the urinary passage.

This is a double-blind randomized study, which means neither the participant, nor the study doctor will know which treatment group the participant will be in. Participants who are randomly chosen to receive injection with placebo will have the option to receive an injection with their cells after completion of the blinded portion of their study participation (12 months).

Clinical Study Identifier: NCT03104517

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Beaumont Hospital, Royal Oak

Royal Oak, MI United States
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Urology of Virginia, PLLC

Virginia Beach, VA United States
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Magee Women's Hospital of UPMC

Pittsburgh, PA United States
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Derriford Hospital

Plymouth, United Kingdom
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McKay Urology

Charlotte, NC United States
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Prisma Health - Upstate

Greenville, SC United States
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