Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study

Urinary Incontinence, Stress Clinical Trial

Official title:

A Double-blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Effectiveness of Cook MyoSite Incorporated AMDC in Female Patients With Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382602
• Other study ID #: 10-019
• Status: Completed
• Phase: Phase 3
• Start date: November 4, 2011
• Est. completion date: January 29, 2017

Study information

• Verified date: April 2018
• Source: Cook MyoSite
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 29, 2017
• Est. primary completion date: February 3, 2016
• 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 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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Biological:
• AMDC-USR
AMDC-USR Treatment
• Placebo
Placebo treatment

Locations

Country	Name	City	State
Canada	Foothills Medical Center	Calgary	Alberta
Canada	Southern Alberta Institute of Urology	Calgary	Alberta
Canada	Centre for Applied Urological Research Queens University	Kingston	Ontario
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Can-Med Clinical Research Inc.	Victoria	British Columbia
Canada	Victoria Gynecology and Continence Clinic	Victoria	British Columbia
Germany	Praxisklinik Urologie Rhein-Ruhr	Mülheim
United Kingdom	Worthing Hospital	Worthing

Sponsors (1)

Lead Sponsor	Collaborator
Cook MyoSite

Countries where clinical trial is conducted

Canada,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Response (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 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.	12 months