Eligibility

Criteria for participation:

·          Male or female18 years of age or older

·          Must weigh > 40 kg (88 lbs.)

·          Have symptoms of idiopathic overactive bladder with urinary urgency incontinence for a period of at least six months immediately prior to screening

·          Experiences ≥ 3 episodes of urinary urgency incontinence, with no more than one incontinence-free day

·          Experiences urinary frequency, defined as an average of ≥ 8 micturitions (voluntary voids) per day

·          Negative pregnancy test result if female and of childbearing potential

·          Cannot have symptoms of overactive bladder due to any known neurological reason (eg, spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer’s disease, Parkinson’s disease, etc.)

·          Cannot have a predominance of stress incontinence, determined by patient history

·          No anticholinergics or any other medications or therapies to treat symptoms of overactive bladder, including nocturia, within twenty-eight days of Randomization/Day 1

·          Cannot utilize CIC or indwelling catheter to manage their urinary incontinence

·          No previous treatment with any intravesical pharmacologic agent (eg, capsaicin, resiniferatoxin) within twelve months of Randomization/Day 1

·          No previous or current botulinum toxin therapy of any serotype for any urological condition

·          No previous or current botulinum toxin therapy of any serotype for any non-urological condition within twelve weeks of Randomization/Day 1

·          No history of interstitial cystitis

·          Patient has an active genital infection, other than genital warts, either concurrently or within four weeks prior to screening

·          No previous history or current diagnosis of bladder cancer

·          No males with previous or current diagnosis of prostate cancer

·          No hemophilia, or other clotting factor deficiencies, or disorders that cause bleeding diathesis

·          No females who are pregnant, nursing or planning a pregnancy

Duration of Study

Patients will participate in the study for a minimum duration of twenty-four weeks and a maximum duration of thirty-eight weeks.