Autologous Cell Therapy for Stress Urinary Incontinence in Males 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.