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

Use our guide to learn which trials are right for you!

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
sites
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
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...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
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...
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
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...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
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...
?
mi
from
Weston, FL
Click here to add this to my saved trials
?
mi
from
Agoura Hills, CA
Click here to add this to my saved trials
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...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Houston, Texas 77024
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Leuven,
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
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...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Phoenix, Arizona 85054
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
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...
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials
Royal Oak, Michigan 48073
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Skokie, Illinois 60076
?
mi
from
Skokie, IL
Click here to add this to my saved trials
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
?
mi
from
Stanford, CA
Click here to add this to my saved trials