Status:
COMPLETED
An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence
Lead Sponsor:
Cook MyoSite
Conditions:
Stress Urinary Incontinence
Cell Therapy
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 inc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 9 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2011
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00847535
Start Date
October 9 2008
End Date
November 2 2011
Last Update
September 8 2023
Active Locations (3)
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1
Wm Beaumont Hospital
Royal Oak, Michigan, United States, 48073
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
3
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5