Phase 3
N=297
Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
Stress Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT01893138 ↗Enrolled (actual)
297
Serious AEs
6.1%
Results posted
Jan 2023
Primary outcome: Primary: Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary — 103; 52 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Other); Iltamiocel (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Cook MyoSite
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary |
103; 52 | — |
| SECONDARY Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months |
73; 30 | — |
| SECONDARY Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months |
53; 22 | — |
| SECONDARY Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months |
-5.8; -4.9 | — |
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 Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01893138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.