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

Study Identifier
191622-125
CT.gov Identifier
NCT01767519
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Bladder Disorder - Overactive Bladder
    • Study Drug
  • BOTOX®
  • solifenacin
  • Botox placebo (normal saline)
  • solifenacin placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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

    Protocol Summary

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

    Study Locations

    Location
    Status
    Location
    Newport Beach, California, United States
    Status
    Not applicable
    Location
    Leuven, Belgium
    Status
    Not applicable
    Location
    Vancouver, British Columbia, Canada
    Status
    Not applicable
    Location
    Toronto, Ontario, Canada
    Status
    Not applicable
    Location
    Prague, Czech Republic
    Status
    Not applicable
    Location
    Berlin, Germany
    Status
    Not applicable
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