Overview

OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder

Status:
Completed
Trial end date:
2017-01-05
Target enrollment:
0
Participant gender:
All
Summary
This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Allergan
Treatments:
abobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
incobotulinumtoxinA
onabotulinumtoxinA
Criteria
Inclusion Criteria:

-Patients with symptoms of Overactive Bladder (OAB) (frequency and urgency) with urinary
incontinence for at least 6 months prior to screening.

Exclusion Criteria:

- Symptoms of OAB due to a neurological reason

- Use of anticholinergics or other medications or therapies to treat symptoms of OAB
within 7 days of screening

- Use of Clean Intermittent Catheterization (CIC) or indwelling catheter to manage
urinary incontinence

- Use of botulinum toxin therapy of any serotype for any urological condition

- Use of botulinum toxin therapy of any serotype for any non-urological condition in the
12 weeks prior to screening

- History of any pelvic or urological abnormalities, bladder surgery or disease, other
than OAB, that may affect bladder function

- Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral
Sclerosis.