A Double-blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Effectiveness of Cook MyoSite Incorporated AMDC in Female Patients With Stress Urinary Incontinence
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 20
- Primary Endpoint
- Percentage of Participants With Response (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 12 Months
Study Overview
Brief Summary
This is a clinical trial to study the safety and effectiveness of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of female stress urinary incontinence (SUI).
Detailed Description
Study comparing intrasphincteric injection of AMDC-USR with placebo. Subjects unblinded after 12 months visits, but followed for 2 years. Subjects randomized to placebo could elect to receive open-label AMDC-USR after completing 12 months visit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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 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.
Arms & Interventions
Placebo
Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded and could elect to receive open-label AMDC-USR treatment. Subjects that received unblinded AMDC-USR treatment were followed for 2 years after initial placebo treatment.
Intervention: Placebo (Biological)
AMDC-USR
Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded. Subjects were followed for 2 years after initial AMDC-USR treatment.
Intervention: AMDC-USR (Biological)
Outcomes
Primary Outcomes
Percentage of Participants With Response (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 12 Months
Time Frame: 12 months
A composite primary endpoint of responder rate was used, where a subject was considered a responder if she had ≥ 50% reduction from baseline in stress Incontinence Episode Frequency (stress IEF; reported stress leaks from 3-day diary) or ≥ 50% reduction in leakage from baseline as determined by either the in-office pad weight test or the 24-hour pad weight test.
Secondary Outcomes
No secondary outcomes reported