Autologous Muscle Derived Cells for Female Urinary Sphincter Repair



Status:Active, not recruiting
Conditions:Urology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:1/19/2019
Start Date:October 2013
End Date:August 2020

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A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence

This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will
evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle Derived Cells
for Urinary Sphincter Repair (AMDC-USR) compared to a placebo (vehicle) control dose in the
treatment of stress urinary incontinence (SUI) in adult female patients.


Inclusion Criteria:

- Female patient has primary symptoms of SUI, as confirmed by patient medical history
and clinical symptoms, including a focused incontinence evaluation.

Exclusion Criteria:

- Patient has symptoms of pure urge incontinence as confirmed by basic evaluation of
etiology from a patient medical history, including a focused incontinence history.

- Patient has symptoms of mixed urinary incontinence where urge incontinence is the
predominant factor.

- Patient has had stress urinary incontinence symptoms less than 6 months prior to
signing the informed consent.

- Patient has not previously attempted conservative treatment prior to signing the
informed consent. (Examples of conservative treatment include behavior modifications,
bladder exercises, biofeedback, etc.)

- Patient has more than 2 episode of awakening to void during normal sleeping hours.

- Patient cannot be maintained on a stable dose and/or frequency of medication
(including diuretics) known to affect lower urinary tract function, including but not
limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers,
for at least 2 weeks prior to screening or is likely to change during the course of
the study.

- Patient is pregnant, lactating, or plans to become pregnant during the course of the
study.

- Patient refuses to provide written informed consent.

- Patient is not at least 18 years of age.

- Patient is not available for the follow-up evaluations as required by the protocol.
We found this trial at
27
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Falls Church, VA
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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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Nashville, TN
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Weston, FL
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28207
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Grand Rapids, MI
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Grand Rapids, Michigan 49503
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Greenville, South Carolina 29615
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Houston, Texas 77024
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Indianapolis, Indiana 46202
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Leuven,
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Los Angeles, California 90095
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New York, New York 10016
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Phoenix, Arizona 85054
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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Royal Oak, Michigan 48073
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Skokie, Illinois 60076
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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