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Sponsors and Collaborators: |
Veterans Medical Research Foundation Allergan |
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Information provided by: | Veterans Medical Research Foundation |
ClinicalTrials.gov Identifier: | NCT00850733 |
The specific aim of this study is to evaluate the safety and efficacy of each of 2 dosages of BOTOX® (200 U or 300 U) compared to placebo injected into the detrusor for the treatment of urinary incontinence caused by neurogenic detrusor overactivity in patients who have not been adequately managed with anticholinergic therapy.
Condition |
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Urinary Incontinence Urinary Bladder, Overactive |
Study Type: | Observational |
Official Title: | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of Safety and Efficacy of a Single Treatment With 2 Dose Levels of BOTOX Purified Neurotoxin Complex Followed by a Treatment With BOTOX in Patients With… |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
The study will recruit 260 patients nationwide with an expected recruitment of 6 patients at the VA San Diego Healthcare System. Patients must be between 18-80 years of age and will include patients with neurogenic detrusor overactivity as a result of spinal cord injury or multiple sclerosis, with urinary incontinence, who have not been adequately managed with anticholinergic therapy. 50% of the patients randomized will be of spinal cord injury etiology and 50% of multiple sclerosis etiology.
Inclusion Criteria:
Patient has urinary incontinence as a result of neurogenic detrusor overactivity for a period of at least 3 months prior to screening as a result of spinal cord injury or multiple sclerosis, determined by documented patient history. In addition:
Patient has a negative pregnancy result if female and of childbearing potential.
The following criteria are also required for entry into the study at Randomization/Day 1:
Exclusion Criteria:
Patient has history or evidence of any pelvic or urological abnormalities including but not limited to the following:
Responsible Party: | Veterans Medical Research Foundation ( Michael Albo, MD ) |
Study ID Numbers: | 071304, VMRF Project #07366 |
Study First Received: | February 20, 2009 |
Last Updated: | February 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00850733 History of Changes |
Health Authority: | United States: Institutional Review Board |
Signs and Symptoms Urinary Bladder, Overactive Cystocele Urologic Diseases |
Urination Disorders Urinary Bladder Diseases Urinary Incontinence Botulinum Toxin Type A |
Signs and Symptoms Urological Manifestations Urinary Bladder, Overactive Urologic Diseases |
Urination Disorders Urinary Bladder Diseases Urinary Incontinence |