Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
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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 :
Completed
First Posted : July 8, 2013
Last Update Posted : April 19, 2021
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Condition or disease | Intervention/treatment | Phase |
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Stress Urinary Incontinence | Biological: Roll-in: AMDC for USR Other: Placebo Biological: AMDC for USR Other: Roll in: Placebo | Phase 3 |
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 |

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.
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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.
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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. |
- Number of leaks due to stress incontinence episodes, as recorded in a diary [ Time Frame: 12 months ]
- Stress leak frequency [ Time Frame: 12 months ]

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

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

Principal Investigator: | Melissa Kaufman, M.D., Ph.D. | Vanderbilt University Medical Center, Department of Urologic Surgery |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Urinary Incontinence, Stress Tissue Therapy (Cell Therapy) Transplantation, Autologous |
Urinary Incontinence Enuresis Urinary Incontinence, Stress Urination Disorders Urologic Diseases |
Lower Urinary Tract Symptoms Urological Manifestations Behavioral Symptoms Elimination Disorders Mental Disorders |