Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery
Status and phase
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Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
25 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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