MedPath

Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

Phase 3
Completed
Conditions
Stress Urinary Incontinence
Registration Number
NCT01893138
Lead Sponsor
Cook MyoSite
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 Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.

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 open-label iltamiocel after completing 12 month visit.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
311
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day DiaryBaseline and 12 months
Secondary Outcome Measures
NameTimeMethod
Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 MonthsBaseline and 12 months
Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 MonthsBaseline and 12 months
Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 MonthsBaseline and 12 months

Trial Locations

Locations (29)

Mayo Clinic Arizona Phoenix Campus

🇺🇸

Phoenix, Arizona, United States

The American Association of Female Pelvic Medicine Specialists

🇺🇸

Agoura Hills, California, United States

Ronald Reagan UCLA Medical Center

🇺🇸

Los Angeles, California, United States

Stanford University

🇺🇸

Stanford, California, United States

Cleveland Clinic Florida

🇺🇸

Weston, Florida, United States

Emory University

🇺🇸

Atlanta, Georgia, United States

NorthShore University HealthSystem

🇺🇸

Skokie, Illinois, United States

IU Health Physicians Urogynecology

🇺🇸

Indianapolis, Indiana, United States

Female Pelvic Medicine & Urogynecology Institute of Michigan

🇺🇸

Grand Rapids, Michigan, United States

Mercy Health Saint Mary's Campus

🇺🇸

Grand Rapids, Michigan, United States

Scroll for more (19 remaining)
Mayo Clinic Arizona Phoenix Campus
🇺🇸Phoenix, Arizona, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.