A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence

• Status: Completed
• Trial end date: 2015-03-18
• Target enrollment: 0
• Participant gender: All

Summary

A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with overactive bladder (OAB) and urinary incontinence.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA; Solifenacin Succinate

Criteria

Inclusion Criteria:

• Symptoms of Overactive Bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months

• Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion Criteria:

• Overactive Bladder caused by neurological condition

• Patient has predominance of stress incontinence

• Use of anticholinergics or other medications to treat OAB symptoms in the 7 days prior to screening

• Previous use of solifenacin

• History or evidence of pelvic or urological abnormality

• Previous use of any botulinum toxin of any serotype for any urological condition

• Previous use of any botulinum toxin of any serotype for any non-urological condition within 12 weeks of randomization

• Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis