Status:
COMPLETED
Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
Lead Sponsor:
Cook MyoSite
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 (generic name Ilta...
Detailed Description
Study comparing intrasphincteric injection of iltamiocel with placebo. Subjects unblinded after 12 month visits, but followed for up to 2 years. Subjects randomized to placebo could elect to receive o...
Eligibility Criteria
Inclusion
- Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.
Exclusion
- 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.
Key Trial Info
Start Date :
November 21 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2020
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT01893138
Start Date
November 21 2013
End Date
November 10 2020
Last Update
January 5 2023
Active Locations (29)
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1
Mayo Clinic Arizona Phoenix Campus
Phoenix, Arizona, United States, 85054
2
The American Association of Female Pelvic Medicine Specialists
Agoura Hills, California, United States, 91301
3
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90024
4
Stanford University
Stanford, California, United States, 94304