This trial is active, not recruiting.

Condition urinary incontinence, stress
Treatments amdc, placebo control
Phase phase 3
Sponsor Cook MyoSite
Start date December 2011
End date February 2016
Trial size 150 participants
Trial identifier NCT01382602, 10-019


This is a clinical trial is to study the safety and effectiveness of autologous muscle-derived cells (AMDC) for the treatment of female stress urinary incontinence (SUI).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Cell Treatment
(Placebo Comparator)
placebo control
Placebo treatment

Primary Outcomes

Number of stress incontinence episodes or pad weight
time frame: 12 Months
Incidence of treatment-related serious adverse events and the incidence of protocol-defined treatment- or procedure-related adverse events
time frame: 12 Months

Eligibility Criteria

Female participants at least 18 years old.

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 for at least 1 month 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 randomization 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.

Additional Information

Official title A Double-blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Effectiveness of Cook MyoSite Incorporated AMDC in Female Patients With Stress Urinary Incontinence
Principal investigator Lesley K. Carr, MD, FRCSC
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Cook.