Autologous Cell Therapy for Female Stress Urinary Incontinence
NCT ID: NCT01008943
Last Updated: 2021-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2010-06-02
2012-09-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Autologous Muscle Derived Cells
Urethral injection of autologous muscle-derived cells
Interventions
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Autologous Muscle Derived Cells
Urethral injection of autologous muscle-derived cells
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Cook MyoSite
INDUSTRY
Responsible Party
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Principal Investigators
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Lesley K. Carr, MD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Center
Locations
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Foothills Medical Centre
Calgary, Alberta, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Countries
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Related Links
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Autologous muscle derived cells for treatment of stress urinary incontinence in women
Other Identifiers
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09-013
Identifier Type: -
Identifier Source: org_study_id
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