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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
---|---|
Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00231491 |
Overactive bladder induce urgency, urge incontinence, nocturia and pollakiuria. This condition is often resistant to anticholinergic drugs used as a first line treatment for this purpose. Moreover muscarinic side effects (constipation, mouth dryness) often limits the use of those treatments. This study is designed to evaluate the efficacy and safety of botulinum toxin A injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.
Condition | Intervention | Phase |
---|---|---|
Overactive Bladder (OAB) |
Drug: Botulinum Toxin A (Botox ) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder (OAB). A Multicenter Phase II, Randomized, Double-Blind, Placebo Controlled 6 Month Study . VESITOX |
Estimated Enrollment: | 160 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | April 2007 |
This study is designed to evaluate the efficacy and safety of botulinum toxin A injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact: Pierre DENYS, MD | +33(0)-1 47 10 70 72 | pierre.denys@rpc.aphp.fr |
France | |
RAYMOND POINCARE Hospital | Recruiting |
GARCHES, France, 92380 | |
Contact: Philippe DENYS, MD +33(0)-1 47 10 70 72 pierre.denys@rpc.aphp.fr |
Principal Investigator: | Pierre DENYS, MD | Assistance Publique - Hôpitaux de Paris |
Study ID Numbers: | P030438, AOM03111 |
Study First Received: | October 3, 2005 |
Last Updated: | March 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00231491 |
Health Authority: | France: Ministry of Health |
Overactive bladder Urgency Urge incontinence Botulinum toxin A Quality of life |
Signs and Symptoms Urinary Bladder, Overactive Botulinum Toxins Cystocele Urologic Diseases |
Urinary Bladder Diseases Quality of Life Urinary Incontinence Botulinum Toxin Type A Urinary Incontinence, Urge |
Urological Manifestations Anti-Dyskinesia Agents Therapeutic Uses Central Nervous System Agents Pharmacologic Actions |