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

Muscle Cell Mediated Therapy for Stress Urinary Incontinence: An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells.

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.

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