Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

Stress Urinary Incontinence Clinical Trial

Official title:

A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893138
• Other study ID #: 13-003
• Status: Completed
• Phase: Phase 3
• Start date: November 21, 2013
• Est. completion date: November 10, 2020

Study information

• Verified date: December 2022
• Source: Cook MyoSite
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: November 10, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Other:
• Placebo
Placebo control is the vehicle solution used for the study product.

Biological:
• Iltamiocel
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven
Germany	Universitätsklinikum Essen	Essen
Germany	Praxisklinik Urologie Rhein-Ruhr (PUR/R)	Mülheim
United States	The American Association of Female Pelvic Medicine Specialists	Agoura Hills	California
United States	Emory University	Atlanta	Georgia
United States	Montefiore Medical Center	Bronx	New York
United States	Medical University of South Carolina	Charleston	South Carolina
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	Cleveland Clinic	Cleveland	Ohio
United States	Inova Fairfax Hospital	Falls Church	Virginia
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	Greenville Health System	Greenville	South Carolina
United States	Methodist Urology Associates	Houston	Texas
United States	IU Health Physicians Urogynecology	Indianapolis	Indiana
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	NYU Urology Associates	New York	New York
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Mayo Clinic Arizona Phoenix Campus	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Premier Medical Group of the Hudson Valley PC	Poughkeepsie	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Benaroya Research Institute at Virginia Mason	Seattle	Washington
United States	Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic	Sioux Falls	South Dakota
United States	NorthShore University HealthSystem	Skokie	Illinois
United States	Stanford University	Stanford	California
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cook MyoSite

Countries where clinical trial is conducted

United States,  Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency	Spearman's correlation used for analysis	Baseline and 12 months
Other	Treatment Durability at 24 Months	Treatment durability defined as iltamiocel-treated participants with reduction in stress incontinence episode frequency (SIEF) at 12 months who maintained that response at 24 months	Baseline, 12 months, and 24 months after injection with iltamiocel
Primary	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	Participants With at = 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months		Baseline and 12 months
Secondary	Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months		Baseline and 12 months
Secondary	Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months		Baseline and 12 months