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Autologous Cell Therapy for Female Stress Urinary Incontinence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01008943
First received: November 5, 2009
Last updated: December 24, 2012
Last verified: December 2012
History of Changes
  Purpose

The Autologous Cell Therapy for Female SUI study is a clinical trial to determine the safety and potential effectiveness of a single dose of 200 million Cook MyoSite Autologous Muscle Derived Cells for treatment of Stress Urinary Incontinence.


Condition Intervention Phase
Stress Urinary Incontinence
 Biological: Autologous Muscle Derived Cells
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Canadian Prospective Nonrandomized Study of Autologous Cell Therapy for Female Stress Urinary Incontinence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in objective measures of stress urinary incontinence [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: July 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Autologous Muscle Derived Cells
Urethral injection of autologous muscle-derived cells

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • SUI with normal detrusor activity confirmed with urodynamics
  • Bladder capacity >200 ml
  • Incontinence has not shown any improvement for at least -6 months
  • Failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)

Exclusion Criteria:

  • Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
  • Neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
  • Uncontrolled diabetes
  • Pregnant, lactating, or plans to become pregnant during course of the study
  • Morbid obesity (defined as 100 pounds over their ideal body weight, or BMI ≥40) and not expected to benefit from treatment
  • Current or acute conditions involving cystitis or urethritis
  • Scheduled to receive radiation treatment to the vicinity, or history of radiation treatment to the urethra or adjacent structures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008943

Locations
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N2T9
Canada, Ontario
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3 M5
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Lesley K. Carr, MD Sunnybrook Health Sciences Center
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01008943     History of Changes
Other Study ID Numbers: 09-013
Study First Received: November 5, 2009
Last Updated: December 24, 2012
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 16, 2013