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Sponsors and Collaborators: |
Urological Sciences Research Foundation Allergan |
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Information provided by: | Urological Sciences Research Foundation |
ClinicalTrials.gov Identifier: | NCT00479596 |
The current study will investigate the comparative efficacy, safety and patient satisfaction of intradetrusor injections BOTOX® injections (200U) versus placebo (saline) injections in the treatment of OAB secondary to benign prostatic obstruction (BPO).
Condition | Intervention | Phase |
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Overactive Bladder |
Drug: Botox |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy Study of Intradetrusor Injections of Botox® for the Treatment of Urinary Incontinence Secondary to Benign Prostatic Obstruction (BTX0621) |
Estimated Enrollment: | 40 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | May 2007 |
Overactive bladder is a common problem that follows chronic prostatic bladder outlet obstruction and is part of the benign prostatic hyperplasia syndrome (BPH) in men. Unfortunately, it does not often resolve after treatment (TURP, etc) of the obstruction from enlarged prostate gland. Patients with obstructive BPH typically commence treatment with alpha-blockers or anticholinergic agents; the former being used to treat enlarged prostate medically, and the latter to treat overactive bladder symptoms. However, as mentioned, anticholinergics cause many intolerable side effects leading to discontinuation in many patients. Furthermore this class of drug is still considered a relative contraindication in this population by some clinicians.
Therefore other modalities need to be studied in these men. Based on numerous studies in overactive bladder (OAB), we hypothesize that these patients will experience significant improvement (particularly if their symptoms of urgency and frequency) without significant side effects from intradetrusor injections of BOTOX® even though they have were refractory to systemic anticholinergics.
Ages Eligible for Study: | 40 Years to 90 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Leonard S Marks, M.D. | (310) 838-6347 | lsmarks@ucla.edu |
Contact: Malu Macairan, M.D. | (310) 838-6347 | mmacairan@usrf.org |
United States, California | |
Urological Sciences Research Foundation | Recruiting |
Culver City, California, United States, 90232 | |
Contact: Malu Macairan, M.D. 310-838-6347 mmacairan@usrf.org | |
Contact: Anthony Cancio (310) 838-6347 acancio@usrf.org | |
Principal Investigator: Leonard S Marks, M.D. |
Principal Investigator: | Leonard S Marks, M.D. | Urological Sciences Research Foundation |
Study ID Numbers: | BTX0621 |
Study First Received: | May 25, 2007 |
Last Updated: | May 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00479596 History of Changes |
Health Authority: | United States: Institutional Review Board |
Overactive Bladder OAB Refractory OAB Botox Bladder |
Signs and Symptoms Urinary Bladder, Overactive Botulinum Toxins Cystocele Urologic Diseases |
Urinary Bladder Diseases Neoplasm Metastasis Urinary Incontinence Peripheral Nervous System Agents Botulinum Toxin Type A |
Signs and Symptoms Urological Manifestations Urinary Bladder, Overactive Urologic Diseases Physiological Effects of Drugs |
Urinary Bladder Diseases Neuromuscular Agents Peripheral Nervous System Agents Botulinum Toxin Type A Pharmacologic Actions |