Autologous Muscle-derived Cells Female Stress Urinary Incontinence Clinical Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook ( Cook MyoSite )
ClinicalTrials.gov Identifier:
NCT01382602
First received: June 24, 2011
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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 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: 150
Study Start Date: December 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: June 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Can-Med Clinical Research Inc.
Victoria, British Columbia, Canada, V8T 5G1
Victoria Gynecology and Continence Clinic
Victoria, British Columbia, Canada, V8R 6R3
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

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: June 12, 2014
Health Authority: Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Paul-Ehrlich-Institut

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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014