OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder
Status: | Completed |
---|---|
Conditions: | Overactive Bladder, Urology |
Therapuetic Areas: | Gastroenterology, Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/8/2017 |
Start Date: | October 28, 2013 |
End Date: | January 5, 2017 |
This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared
with placebo, in achieving a 100% reduction in urinary incontinence in patients with
overactive bladder (OAB) not properly managed with an anticholinergic.
with placebo, in achieving a 100% reduction in urinary incontinence in patients with
overactive bladder (OAB) not properly managed with an anticholinergic.
Inclusion Criteria:
-Patients with symptoms of Overactive Bladder (OAB) (frequency and urgency) with urinary
incontinence for at least 6 months prior to screening.
Exclusion Criteria:
- Symptoms of OAB due to a neurological reason
- Use of anticholinergics or other medications or therapies to treat symptoms of OAB
within 7 days of screening
- Use of Clean Intermittent Catheterization (CIC) or indwelling catheter to manage
urinary incontinence
- Use of botulinum toxin therapy of any serotype for any urological condition
- Use of botulinum toxin therapy of any serotype for any non-urological condition in the
12 weeks prior to screening
- History of any pelvic or urological abnormalities, bladder surgery or disease, other
than OAB, that may affect bladder function
- Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral
Sclerosis.
We found this trial at
40
sites
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University of Southern California The University of Southern California is one of the world’s leading...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000

Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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State College, Pennsylvania 16801
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