Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery
NCT ID: NCT02291432
Last Updated: 2021-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2015-02-19
2019-06-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AMDC-USR
Cell treatment
autologous muscle-derived cells (AMDC)
Cell treatment
Interventions
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autologous muscle-derived cells (AMDC)
Cell treatment
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
MALE
No
Sponsors
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Cook MyoSite
INDUSTRY
Responsible Party
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Principal Investigators
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Kenneth Peters, MD
Role: PRINCIPAL_INVESTIGATOR
Beaumont Hospital
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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13-11
Identifier Type: -
Identifier Source: org_study_id