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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

November 5, 2009
December 24, 2012
July 2010
October 2012   (final data collection date for primary outcome measure)
Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01008943 on ClinicalTrials.gov Archive Site
Improvement in objective measures of stress urinary incontinence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Autologous Cell Therapy for Female Stress Urinary Incontinence
A Canadian Prospective Nonrandomized Study of Autologous Cell Therapy for Female Stress Urinary Incontinence

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stress Urinary Incontinence
Biological: Autologous Muscle Derived Cells
Urethral injection of autologous muscle-derived cells
Experimental: 1
Intervention: Biological: Autologous Muscle Derived Cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01008943
09-013
Not Provided
Cook
Cook
Not Provided
Principal Investigator: Lesley K. Carr, MD Sunnybrook Health Sciences Center
Cook
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP