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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291432
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Cook MyoSite

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 undergone prior prostate surgery.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Stress Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Biological: autologous muscle-derived cells (AMDC) Phase 1 Phase 2

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 male stress urinary incontinence (SUI) that develops following prostate surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Muscle Cell Mediated Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery: An Investigation of Cook MyoSite Autologous Muscle Derived Cells
Study Start Date : December 2014
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AMDC-USR
Cell treatment
Biological: autologous muscle-derived cells (AMDC)
Cell treatment




Primary Outcome Measures :
  1. Rate of product-related serious adverse events [ Time Frame: 24 months ]
  2. Rate of product-related, biopsy procedure-related, and injection procedure-related adverse events [ Time Frame: 24 months ]
  3. Volume of post-void residual urine [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Amount of urine leakage [ Time Frame: 12 months ]
  2. Change is patient-reported quality of life assessed by a questionnaire [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291432


Locations
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United States, Florida
University of Miami School of Medicine
Miami, Florida, United States, 33136
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, North Carolina
McKay Urology
Charlotte, North Carolina, United States, 28207
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Cook MyoSite
Investigators
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Principal Investigator: Kenneth Peters, MD Beaumont Hospital
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Responsible Party: Cook MyoSite
ClinicalTrials.gov Identifier: NCT02291432    
Other Study ID Numbers: 13-11
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cook MyoSite:
Urinary Incontinence, Stress
Tissue Therapy (Cell Therapy)
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urologic Diseases
Urination Disorders
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders