Autologous Muscle-derived Cells Female Stress Urinary Incontinence Clinical Study

This study is currently recruiting participants.
Verified February 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook ( Cook MyoSite )
ClinicalTrials.gov Identifier:
NCT01382602
First received: June 24, 2011
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

This is a clinical trial approved by Health Canada to study the safety and effectiveness of autologous muscle-derived cells (AMDC) for the treatment of female stress urinary incontinence (SUI).


Condition Intervention Phase
Urinary Incontinence, Stress
Biological: AMDC
Biological: Placebo Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Number of stress incontinence episodes or pad weight [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Incidence of treatment-related serious adverse events and the incidence of protocol-defined treatment- or procedure-related adverse events [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 246
Study Start Date: December 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMDC Biological: AMDC
Cell Treatment
Placebo Comparator: Placebo Control Biological: Placebo Control
Placebo treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382602

Contacts
Contact: Patricia Kultgen 765-463-7537 pkultgen@medinst.com

Locations
Belgium
Universitaire Ziekenhuizen K.U.Leuven Not yet recruiting
Leuven, Belgium, 3000
Contact: Dirk DeRidder, MD       dirk.deridder@uz.kuleuven.ac.be   
Canada, Alberta
Foothills Medical Center Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Magali Robert, MD    403-944-1636      
Southern Alberta Institute of Urology Recruiting
Calgary, Alberta, Canada, T2V 1P9
Contact: Kevin Carlson, MD    403-943-8978      
Canada, British Columbia
Can-Med Clinical Research Inc. Withdrawn
Victoria, British Columbia, Canada, V8T 5G1
Victoria Gynecology and Continence Clinic Recruiting
Victoria, British Columbia, Canada, V8R 6R3
Contact: David Quinlan, MD    250-595-1095      
Canada, Nova Scotia
IWK Health Centre Terminated
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
Centre for Applied Urological Research Queen s University Not yet recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Stephen S. Steele, MD    (613) 548-6090    steeles@kgh.kari.net   
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Harold Drutz, MD, FRCSC    416-586-4642      
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Lesley K. Carr, MD, FRCSC    1-416-480-5113    lesley.carr@sunnybrook.ca   
Canada, Quebec
Center Hospitalier de Fleurimont Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Le-Mai Tu, MD    819-820-6868 ext 14595      
Germany
Universitätsklinikum Essen, Klinik für Urologie Not yet recruiting
Essen, Germany, 45147
Contact: Herbert Rubben    +49 (0) 201-723-32 11      
Praxisklinik Urologie Rhein-Ruhr Recruiting
Mülheim, Germany, 45468
Contact: Tim Schneider, MD    +49(0)208-94067900    t.schneider@pur-r.de   
Hong Kong
Prince of Wales Hospital, The Chinese University of Hong Kong Not yet recruiting
Hong Kong, Hong Kong
Contact: Anthony Ng    852-26321663      
Queen Mary Hospital, Hong Kong University Not yet recruiting
Hong Kong, Hong Kong
Contact: Ada Tsui-Lin Ng    852-22554852      
Netherlands
University Hospital Maastricht - Urology Department Not yet recruiting
Maastricht, Netherlands, 6229
Contact: Gommert A Van Koeveringe    +31 433875254    g.van.koeveringe@mumc.nl   
United Kingdom
Worthing Hospital Recruiting
Worthing, United Kingdom, BN11 2DH
Contact: Waleed Al-Singary    01903 205111 ext 4085    waleed.alsingary@wsht.nhs.uk   
Sponsors and Collaborators
Cook MyoSite
Investigators
Principal Investigator: Lesley K. Carr, MD, FRCSC Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Cook ( Cook MyoSite )
ClinicalTrials.gov Identifier: NCT01382602     History of Changes
Other Study ID Numbers: 10-019
Study First Received: June 24, 2011
Last Updated: February 4, 2014
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014