Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery

Muscle Cell Mediated Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery: An Investigation of Cook MyoSite Autologous Muscle Derived Cells

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.