Autologous Cell Therapy for Female Stress Urinary Incontinence

This study is ongoing, but not recruiting participants.

First Received on November 5, 2009. Last Updated on September 21, 2011 History of Changes

Sponsor:	Cook
Information provided by (Responsible Party):	Cook
ClinicalTrials.gov Identifier:	NCT01008943

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 II

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:

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

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 ]

Estimated Enrollment:	16
Study Start Date:	July 2010
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	October 2011 (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:	September 21, 2011
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 February 09, 2012