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.