Evaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence

Inclusion Criteria:

- Participant weighs ≥ 40 kg (88 lb)

- Participant has symptoms of Over Active Bladder (OAB) (frequency and urgency) with
urinary incontinence for a period of at least 6 months immediately prior to screening.

Exclusion Criteria:

- Participant has symptoms of OAB due to any known neurological reason (eg, spinal cord
injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's
disease, etc.)

- Participant has received pharmacologic therapy to treat symptoms of OAB, including
nocturia, within 7 days of the start of the screening period procedures

- Participant uses clean intermittent catheterization (CIC) or indwelling catheter to
manage urinary incontinence

- Participant has been treated with any intravesical pharmacologic agent (eg, capsaicin,
resiniferatoxin) within 12 months of Day 1

- Participant has had previous or current botulinum toxin therapy of any serotype for
any urological condition

- Participant has had previous or current botulinum toxin therapy of any serotype for
any non-urological condition within 12 weeks of Day 1

- Participant has been immunized for any botulinum toxin serotype

- Participant has history or evidence of any pelvic or urological abnormalities, bladder
surgery or disease, other than OAB, that may affect bladder function

- Participant has an active genital infection, other than genital warts, either
concurrently or within 4 weeks prior to screening

- Participant has a history or current diagnosis of bladder cancer or other urothelial
malignancy

- Participant is male with previous or current diagnosis of prostate cancer

- Participant has a history of 2 or more urinary tract infections (UTIs) within 6 months
of Day 1 or is taking prophylactic antibiotics to prevent chronic UTIs

- Participant has current or previous uninvestigated hematuria

- Participant has hemophilia, or other clotting factor deficiencies, or disorders that
cause bleeding diathesis

- Participant cannot withhold any antiplatelet, anticoagulant therapy or medications
with anticoagulant effects for 3 days prior to Day 1

- Participant has a known allergy or sensitivity to any botulinum toxin preparation

- Participant has any medical condition that may put him/her at increased risk with
exposure to BOTOX® including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or
amyotrophic lateral sclerosis

- Participant has current swallowing or breathing difficulties.