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

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