MedTrace Logo

Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study

NCT01382602 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-05-17

Study results available
· View outcomes & findings →

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).

Conditions

  • Urinary Incontinence, Stress

Interventions

BIOLOGICAL

AMDC-USR

AMDC-USR Treatment

BIOLOGICAL

Placebo

Placebo treatment

Sponsors & Collaborators

  • Cook MyoSite

    lead INDUSTRY

Principal Investigators

  • Lesley K. Carr, MD, FRCSC · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-04
Primary Completion
2016-02-03
Completion
2017-01-29
FDA Drug
Yes

Countries

  • Canada
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01382602 on ClinicalTrials.gov