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An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook ( Cook MyoSite )
ClinicalTrials.gov Identifier:
NCT00847535
First received: February 18, 2009
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

This is a clinical investigation approved by US FDA and Canadian Health Authority to study the safety and potential effectiveness of the autologous muscle cells for the treatment of stress urinary incontinence.


Condition Intervention
Stress Urinary Incontinence
Cell Therapy
 Biological: autologous muscle cell injection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Muscle Cell Mediated Therapy for Stress Urinary Incontinence: An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells.

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 urinary stress incontinence [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: September 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Transurethral dose escalation
 Biological: autologous muscle cell injection
Injection of autologous muscle cells
2
Periurethral dose escalation
 Biological: autologous muscle cell injection
Injection of autologous muscle cells

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient has known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
  • Patient has a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
  • Patient has uncontrolled diabetes
  • Patient is pregnant, lactating, or plans to become pregnant during the course of the study
  • Patient is morbidly obese (defined as 100 pounds over their ideal body weight, or BMI ≥40) and would not be expected to benefit from treatment
  • Patient has current or acute conditions involving cystitis or urethritis
  • Patient is scheduled to receive radiation treatment to the vicinity
  • Patients with a history of radiation treatment to the urethra or adjacent structures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847535

Locations
United States, Michigan
Wm Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Canada, Ontario
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Cook MyoSite
Investigators
Principal Investigator: Kenneth Peters, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Cook ( Cook MyoSite )
ClinicalTrials.gov Identifier: NCT00847535     History of Changes
Other Study ID Numbers: 08-006, IND1
Study First Received: February 18, 2009
Last Updated: March 19, 2013
Health Authority: United States: Food and Drug Administration
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 22, 2013