A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence
Status: | Completed |
---|---|
Conditions: | Overactive Bladder, Urology |
Therapuetic Areas: | Gastroenterology, Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | March 2013 |
End Date: | March 2015 |
A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with
overactive bladder (OAB) and urinary incontinence.
overactive bladder (OAB) and urinary incontinence.
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
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