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Clinical Study: Potential New Treatment for Stress Urinary Incontinence

Stress urinary incontinence is the most common form of incontinence in women under the age of 50. With this form of incontinence, involuntary urine leakage can occur during laughing, coughing or sneezing. A clinical trial is evaluating a potential new therapy for this condition that is based on research at Wake Forest Institute for Regenerative Medicine.

Open to women 18 to 75 years old, the study involves isolating muscle progenitor cells from a small biopsy of skeletal muscle. Progenitor cells are found throughout the body and are used to replace cells that are damaged or die naturally with age. The cells will be expanded in a special cell processing facility and then injected into the patient’s bladder neck sphincter region.

Once injected, the cells remain in the body and it is believed that they will provide increased resistance at the bladder opening. Similar treatments have been performed in animals and were found to be safe and show improvement.

All participants will be followed at 1 week, 6 weeks, 3 months, 6 months and 12 months post-injection. The study is evaluating safety as well as changes in incontinence based on number of incontinence episodes and pads used per day and quality of life. Patients will be compensated for their time.

For more details on the study, including detailed inclusion and exclusion criteria, please visit (study ID number: NCT01953315), or contact the study coordinator, Mary-Clare Day, RN, BSN, at 336-713-1343 or

SUI Clinical Study Flyer

Last Updated: 05-31-2016
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