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Trial record 3 of 3 for:    The American Association of Female Pelvic Medicine Specialists
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Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

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ClinicalTrials.gov Identifier: NCT01893138
Recruitment Status : Completed
First Posted : July 8, 2013
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Cook MyoSite

Study Description
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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: AMDC for USR Other: Placebo Biological: AMDC for USR Other: Roll in: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual 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 : November 1, 2019
Actual Study Completion Date : November 10, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Roll-in: AMDC for USR
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: AMDC for USR
AMDC for USR is the study product (autologous muscle derived cells for urinary sphincter repair).
Placebo Comparator: Placebo
Placebo control is the vehicle solution used for the study product.
 Other: Placebo
Placebo control is the vehicle solution used for the study product.
Experimental: AMDC for USR
AMDC for USR is the study product (autologous muscle derived cells for urinary sphincter repair).
 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
Placebo Comparator: Roll in: Placebo
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.
 Other: Roll in: Placebo
Placebo control is the vehicle solution used for the study product.


Outcome Measures
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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
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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
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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
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Sponsors and Collaborators
Cook MyoSite
Investigators
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Principal Investigator: Melissa Kaufman, M.D., Ph.D. Vanderbilt University Medical Center, Department of Urologic Surgery
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: April 19, 2021
Last Verified: April 2021
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)
Transplantation, Autologous
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
 Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders