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Autologous Muscle-derived Cells Female Stress Urinary Incontinence Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01382602
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a clinical trial is to study the safety and effectiveness of autologous muscle-derived cells (AMDC) for the treatment of female stress urinary incontinence (SUI).

Condition or disease Intervention/treatment Phase
Urinary Incontinence, Stress Biological: AMDC Biological: Placebo Control Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : December 2011
Primary Completion Date : January 14, 2016
Study Completion Date : January 29, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: AMDC Biological: AMDC
Cell Treatment
Placebo Comparator: Placebo Control Biological: Placebo Control
Placebo treatment


Outcome Measures

Primary Outcome Measures :
  1. Number of stress incontinence episodes or pad weight [ Time Frame: 12 Months ]
  2. Incidence of treatment-related serious adverse events and the incidence of protocol-defined treatment- or procedure-related adverse events [ Time Frame: 12 Months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382602


Locations
Canada, Alberta
Foothills Medical Center
Calgary, Alberta, Canada, T2N 2T9
Southern Alberta Institute of Urology
Calgary, Alberta, Canada, T2V 1P9
Canada, British Columbia
Victoria Gynecology and Continence Clinic
Victoria, British Columbia, Canada, V8R 6R3
Can-Med Clinical Research Inc.
Victoria, British Columbia, Canada, V8T 5G1
Canada, Ontario
Centre for Applied Urological Research Queen s University
Kingston, Ontario, Canada, K7L 2V7
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1Z5
Canada, Quebec
Center Hospitalier de Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Germany
Praxisklinik Urologie Rhein-Ruhr
Mülheim, Germany, 45468
United Kingdom
Worthing Hospital
Worthing, United Kingdom, BN11 2DH
Sponsors and Collaborators
Cook MyoSite
Investigators
Principal Investigator: Lesley K. Carr, MD, FRCSC Sunnybrook Health Sciences Centre
More Information

Responsible Party: Cook MyoSite
ClinicalTrials.gov Identifier: NCT01382602     History of Changes
Other Study ID Numbers: 10-019
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cook Group Incorporated ( Cook MyoSite ):
Urinary Incontinence, Stress
Tissue Therapy (Cell Therapy)
Transplantation, Autologous

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders