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Autologous Muscle Derived Cells for Stress Urinary Incontinence in Men
The purpose of this study is to evaluate the safety and efficacy of a new medical procedure in which the patient's own muscle cells are collected, processed, and then re-injected into the tissues of their urinary passage. The product being tested is Cook MyoSite Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR), which is a preparation of the patient's own muscle cells that are collected, expanded, and then injected into the tissues of the urinary passage.
Who may be Eligible
Male, at least 18 years old, with primary symptoms of SUI following prostate surgery that occurred at least 12 months prior to enrollment, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation. Inclusion: Patient has undergone prostate surgery such as radical prostatectomy or prostate resectioin, but has not undergone radiation therapy, cryotherapy, or high-intensity focused ultrasound of the prostate. SUI severity should be >10 g and < 400 g of urine leakage over 24 hours, as determined by a 24-hour pad test during screening. Patient has failed to achieve acceptable resolution of SUI symptoms following prior therapy.