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Urinary Incontinence

For enrollment information involving the following trials, please contact one of the research staff members on the "Meet the Team" page.

Urinary Incontinence - MyoSite Study (AMDC-USR)

Urinary Incontinence - MyoSite Study (AMDC-USR)

A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR with Placebo in Female Subjects with Stress Urinary Incontinence (SUI)

Eligible Treatment Centers

• Emory University Hospital
• The Emory Clinic

ELIGIBILITY

• Adult female (>18 Years) with primary stress urinary incontinence SUI (moderate-to-severe)
• Involuntary leakage of urine on effort, excersion, sneezing or coughing
• Bladder capacity of >200mL
• Post void residual (PVR) urine volume <150mL (repeated testing)
• Limited hypermobility of the urethra with Valsava (Q-tip test <30 degrees)

EXCLUSION CRITERIA

• Less than 6 month of stress urinary incontinence symptoms
• No prior conservative therapy for stress urinary incontinence
• Less than 1 episode per day of stress incontinence (average)
• More than 15 episodes per day of stress incontinence episodes (average)
• More than 2 episodes of awakening to void during normal sleeping hours
• Participating in another investigational drug, device or procedure study within the past 6 months

TREATMENT
Female patients with SUI who qualify for the study will be randomized into either a treatment group or placebo group. The treatment group will receive MyoSite Incorporated Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR). This consists of having the patients own muscle cells harvested, grown/expanded in the laboratory, and then injected back into her urinary sphincter. The objective is to repair the natural urinary sphincter (improve its function) so to control and prevent the urine leakage. Such treatment will avoid placement of any devices and foreign material that have the potential to get infected and erode through tissue. The control group will not receive the muscle cells. The study will enroll 267 patients (179 treatment subjects and 89 controls). Patients will be assessed for improvement in urinary incontinence symptoms at 1 month, 3 months, 6 months, 12 months, and 2 years following treatment.

SPONSOR: Cook MyoSite, Incorporated

Principal Investigator: Dr. Galloway

Co-Investigators & Collaborators:
Dr. Northington (OB/GYN)

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