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



Status:Active, not recruiting
Conditions:Other Indications, Overactive Bladder, Overactive Bladder, Urology, Urology, Urology
Therapuetic Areas:Gastroenterology, Nephrology / Urology, Other
Healthy:No
Age Range:18 - Any
Updated:1/19/2019
Start Date:December 2014
End Date:June 2019

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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 of autologous muscle-derived cells (AMDC) for the treatment of male
stress urinary incontinence (SUI) for patients that have undergone prior 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.
We found this trial at
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Charlotte, North Carolina 28207
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Royal Oak, Michigan 48073
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