Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

Phase 3

Completed

Conditions: Stress Urinary Incontinence

Interventions: Other: Placebo
Biological: Iltamiocel

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo control is the vehicle solution used for the study product.
Iltamiocel	Iltamiocel	AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells.

Primary Outcome Measures

Name	Time	Method
Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary	Baseline and 12 months

Secondary Outcome Measures

Name	Time	Method
Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months	Baseline and 12 months
Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months	Baseline and 12 months
Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months	Baseline 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
Stanford University
🇺🇸
Stanford, California, United States
Cleveland Clinic Florida
🇺🇸
Weston, Florida, 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
NYU Urology Associates
🇺🇸
New York, New York, United States
Premier Medical Group of the Hudson Valley PC
🇺🇸
Poughkeepsie, New York, United States
McKay Urology
🇺🇸
Charlotte, North Carolina, United States
The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
🇺🇸
Cincinnati, Ohio, United States
University of Oklahoma Health Sciences Center
🇺🇸
Oklahoma City, Oklahoma, United States
Greenville Health System
🇺🇸
Greenville, South Carolina, United States
Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
🇺🇸
Sioux Falls, South Dakota, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Inova Fairfax Hospital
🇺🇸
Falls Church, Virginia, United States
University Hospital Leuven
🇧🇪
Leuven, Belgium
Universitätsklinikum Essen
🇩🇪
Essen, Germany
Praxisklinik Urologie Rhein-Ruhr (PUR/R)
🇩🇪
Mülheim, Germany
Ronald Reagan UCLA Medical Center
🇺🇸
Los Angeles, California, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
NorthShore University HealthSystem
🇺🇸
Skokie, Illinois, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
IU Health Physicians Urogynecology
🇺🇸
Indianapolis, Indiana, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Methodist Urology Associates
🇺🇸
Houston, Texas, United States
Benaroya Research Institute at Virginia Mason
🇺🇸
Seattle, Washington, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Montefiore Medical Center
🇺🇸
Bronx, New York, United States