NEUROTOX: Two Dosages of Type A Botulinic Toxin in Neurogenic Overactive Bladder

This study has been terminated.

( the study has concluded normally; )

First Received on September 13, 2005. Last Updated on March 3, 2008 History of Changes

Sponsor:	University Hospital, Rouen
Information provided by:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT00213577

Purpose

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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:

complete urinary continence at baseline, and days 30, 90, 180, and 360

Secondary Outcome Measures:

number of mictions or self catheterizations a day
number of leakages, urgency adverse events
guarding times
urodynamics: bladder capacity, reflex volume, residual maximal capacity detrusor pressure, flow detrusor pressure

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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Neurogenic urinary incontinence with urodynamic overactivity resistant to anticholinergic

Exclusion Criteria:

Pregnancy
Bladder cancer
Symptomatic urinary infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213577

Locations

France
CHU-Rouen
Rouen, France, 76031

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator:

Philippe GRISE, MD

CHU de Rouen

More Information

No publications provided by University Hospital, Rouen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Grise P, Ruffion A, Denys P, Egon G, Chartier Kastler E. Efficacy and tolerability of botulinum toxin type A in patients with neurogenic detrusor overactivity and without concomitant anticholinergic therapy: comparison of two doses. Eur Urol. 2010 Nov;58(5):759-66. Epub 2010 Jul 3.

ClinicalTrials.gov Identifier:	NCT00213577 History of Changes
Other Study ID Numbers:	2003/112/HP
Study First Received:	September 13, 2005
Last Updated:	March 3, 2008
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Rouen:

overactive neurogenic bladder

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012