Last updated on August 2019

Muscle Fiber Fragment Treatment for Urinary Incontinence

Brief description of study

This study is designed to evaluate the safety of autologous muscle fiber fragments for the treatment of urinary incontinence due to incompetent outlet (bladder neck/urethra).

Detailed Study Description

Eligible subjects with a diagnosis of urinary incontinence who give consent to take part will undergo a biopsy of the muscle from the inner thigh under anesthesia. During the same procedure, muscle fiber fragments will be obtained from the sample and then immediately delivered via target injected into the bladder neck sphincter region using an endoscopic needle via cystoscope or under ultrasound guidance. All subjects will be followed at 1 week, 6 weeks, 3 months, 6 months and 12 months post-treatment injection.

Clinical Study Identifier: NCT01953263

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Wake Forest Urology Clinic

Winston-Salem, NC United States
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