Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery
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To study the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) for patients that have undergone prior prostate surgery.
This preliminary, prospective, single-arm clinical study will evaluate the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) that develops following prostate surgery.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male, at least 18 years old, with primary symptoms of SUI following prostate surgery,
Patient has undergone prostate surgery 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,
Patient has failed to achieve acceptable resolution of SUI symptoms following prior therapy.
Symptoms of only urge urinary incontinence,
Symptoms of stress urinary incontinence prior to prostate surgery,
Routinely has more than 2 episodes of awakening to void during normal sleeping hours,
Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy,
Previously treated with a periurethral balloon or adjustable sling for urinary incontinence,
Symptoms of overflow incontinence
Additional medical restrictions as specified in the Clinical Investigation Plan,
Additional anatomical restrictions as specified in the Clinical Investigation Plan.