Status:
COMPLETED
Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery
Lead Sponsor:
Cook MyoSite
Conditions:
Urinary Incontinence
Stress
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 19 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02291432
Start Date
February 19 2015
End Date
June 28 2019
Last Update
November 1 2021
Active Locations (5)
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1
University of Miami School of Medicine
Miami, Florida, United States, 33136
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
3
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
4
McKay Urology
Charlotte, North Carolina, United States, 28207