Inclusion Criteria:
- male or female, aged 18 to 80 years old, weighing 110 pounds or more.
- urinary incontinence as a result of neurogenic detrusor overactivity for a period of at least 3 months prior to screening as a result of spinal cord injury
- must have a stable neurological injury occurring at least 6 months or more.
- has detrusor overactivity demonstrated during the screening period or within 1 year of screening.
- has a negative pregnancy result if female and of childbearing potential.
The following criteria are also required for entry into the study at Randomization/Day 1:
- experiences at least 14 episodes or more of urinary incontinence per week with no more than 2 incontinent-free days.
- currently uses or is willing to use clean intermittent catheterization (CIC) to empty the bladder (indwelling catheter is not permitted).
- Volunteers with a negative urine culture result must take an antibiotic medication for 3 days immediately prior to Randomization/Day 1 and agree to continue antibiotic medication for at least 3 days following treatment. Volunteers with a positive urine culture result indicating urinary tract infection (UTI), must take an antibiotic to which the identified organism is sensitive for at least 3 days immediately prior to Randomization/Day 1, on Randomization/Day 1, and continue for 3 days following the procedure (or longer as needed).
Exclusion Criteria:
- has history or evidence of any pelvic or urological abnormalities including but not limited to the following:
1. elevated serum creatinine more than 2 times the upper limit of normal (reference range)
2. current or history of hematuria, 1) if the hematuria is determined to be a pathologic condition or 2) is uninvestigated
3. interstitial cystitis in the opinion of the investigator bladder stones within 6 months of screening
4. surgery or bladder disease other than detrusor overactivity that may impact bladder function with the exception of surgeries for bladder stones (more than 6 months) and stress incontinence, uterine prolapse, rectocele, or cystocele (more than1year) from screening.
- has had previous or current botulinum toxin therapy within 9 months.
- has been immunized for any botulinum toxin serotype.
- discontinued anticholinergic medication for overactive bladder less than 14 days prior to Randomization/Day 1.
- has a history or current diagnosis of bladder cancer.
- male with previous or current diagnosis of prostate cancer or has a Prostate Specific Antigen (PSA) level greater than 10.0 ng/mL.
- has 24 hour total volume voided more than 3000 mL of urine
- has a post void residual volume above 200 mL.
- has an active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening.
- uses any anti-platelet or anticoagulant therapy or is using medications with anticoagulative effects within 3 days prior to treatment.
- has hemophilia or other clotting factor deficiencies or disorders that cause bleeding diatheses.
- has had concurrent treatment or treatment within 6 months of Randomization/Day 1 with capsaicin or resiniferatoxin.
- currently using or plans to use an implanted or non-implantable electrostimulation/ neuromodulation device for treatment of overactive bladder.
- has a known allergy or sensitivity to any components of the study medication, anesthetics or antibiotics or any other products associated with the treatment and general study procedures.
- has any medical condition that may put the volunteer at increased risk with exposure to onaBoNT-A including diagnosed myasthenia gravis, Eaton-Lambert syndrome or amyotrophic lateral sclerosis.
- female and pregnant, nursing or planning a pregnancy during the study, or of childbearing potential and unable or unwilling to use a reliable form of contraception during the study.
- currently or has previously participated in another therapeutic drug or device study within 30 days of screening.