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

Completed · Phase 3 · Has a placebo group

Conditions studied: Overactive Bladder, Urinary Incontinence

In brief

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

Key facts

Study ID

NCT01767519

Run by

Allergan

People needed

356

Starts

2013-03-01

Expected to finish

2015-03-18

Last updated by the study team

2019-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Newport Beach, California, United States
• Study site — Leuven, Belgium
• Study site — Vancouver, British Columbia, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Prague, Czechia
• Study site — Berlin, Germany
• Study site — Warsaw, Poland
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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