Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of urinary incontinence overactive bladder in patients with a spinal cord injury or multiple sclerosis.

Botulinum toxin Type A 300U has been discontinued from the study after regulatory approval of botulinum toxin Type A 200U. Patients remaining in the study who were allocated to receive botulinum toxin Type A 300U at treatment 2 (and had not yet received it) will receive botulinum toxin Type A 200U instead.

Inclusion Criteria:

• Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
• Inadequate response to anticholinergic medication used to treat overactive bladder.
• Neurological respiratory impairment and abnormal pulmonary function test results

Exclusion Criteria:

• History or evidence of pelvic or urologic abnormality
• Previous or current diagnosis of bladder or prostate cancer
• Symptomatic or untreated urinary tract infection at time of enrollment