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Sponsored by: |
University Hospital, Rouen |
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Information provided by: | University Hospital, Rouen |
ClinicalTrials.gov Identifier: | NCT00213577 |
The purpose of this study is to determine the efficacy and tolerance of 2 dosages (750 versus 500 units) of the Dysport type A botulinic toxin for patient suffering from neurogenic urinary incontinence by an overactive bladder and the failure of anticholinergic drugs.
Condition | Intervention | Phase |
---|---|---|
Overactive Bladder |
Drug: type A botulinum toxin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of the Efficacy and Tolerance of 2 Dosages of Type A Botulinic Toxin in Neurogenic Areactive Bladder Resistant to Oral Medical Treatment |
Enrollment: | 80 |
Study Start Date: | December 2003 |
Study Completion Date: | October 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 2003/112/HP |
Study First Received: | September 13, 2005 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00213577 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
overactive neurogenic bladder |
Urinary Bladder, Neurogenic Signs and Symptoms Urinary Bladder, Overactive Botulinum Toxins |
Cystocele Urologic Diseases Urinary Bladder Diseases |
Signs and Symptoms Urological Manifestations Urinary Bladder, Overactive Botulinum Toxins Urologic Diseases |
Anti-Dyskinesia Agents Therapeutic Uses Urinary Bladder Diseases Central Nervous System Agents Pharmacologic Actions |