Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 3 for:    The American Association of Female Pelvic Medicine Specialists
Previous Study | Return to List | Next Study

Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

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: NCT01893138
Recruitment Status : Active, not recruiting
First Posted : July 8, 2013
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Cook MyoSite

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Biological: Roll-in Other: Placebo Biological: AMDC for USR Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence
Actual Study Start Date : November 21, 2013
Actual Primary Completion Date : October 9, 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Roll-in
Roll-in patients are allowed in the study (up to 12 per site) and are randomized and treated exactly the same as standard study patients.
 Biological: Roll-in
Placebo control is the vehicle solution used for the study product, AMDC for USR is the study product (autologous muscle derived cells for urinary sphincter repair).
Placebo Comparator: Placebo Other: Placebo
Placebo control is the vehicle solution used for the study product.
Experimental: AMDC for USR Biological: AMDC for USR
AMDC for USR is the study product (autologous muscle derived cells for urinary sphincter repair).
Other Name: Autologous muscle derived cells for urinary sphincter repair


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of leaks due to stress incontinence episodes, as recorded in a diary [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Stress leak frequency [ Time Frame: 12 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01893138


Locations
Show Show 29 study locations
Sponsors and Collaborators
Cook MyoSite
Investigators
Layout table for investigator information
Principal Investigator: Melissa Kaufman, M.D., Ph.D. Vanderbilt University Medical Center, Department of Urologic Surgery
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Cook MyoSite
ClinicalTrials.gov Identifier: NCT01893138    
Other Study ID Numbers: 13-003
First Posted: July 8, 2013    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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)
Transplantation, Autologous
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
 Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders