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

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A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with
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
We found this trial at
2
sites
Newport Beach, California 92660
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Newport Beach, CA
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Leuven,
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