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

Completed · Phase 1/Phase 2

Conditions studied: Urinary Incontinence, Stress, Urination Disorders, Urologic Diseases, Lower Urinary Tract Symptoms, Urological Manifestations

In brief

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.

Key facts

Study ID

NCT02291432

Run by

Cook MyoSite

People needed

25

Starts

2015-02-19

Expected to finish

2019-06-28

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Miami School of Medicine — Miami, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• McKay Urology — Charlotte, North Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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