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