Autologous Cell Therapy for Female Stress Urinary Incontinence

This study has been completed.
Information provided by (Responsible Party):
Cook ( Cook MyoSite ) Identifier:
First received: November 5, 2009
Last updated: June 25, 2013
Last verified: June 2013

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:

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


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

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 identifier: NCT01008943

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 MyoSite
Principal Investigator: Lesley K. Carr, MD Sunnybrook Health Sciences Center
  More Information

No publications provided

Responsible Party: Cook ( Cook MyoSite ) Identifier: NCT01008943     History of Changes
Other Study ID Numbers: 09-013
Study First Received: November 5, 2009
Last Updated: June 25, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms processed this record on April 17, 2014