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

This study has been terminated.

( the study has concluded normally; )

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

Sponsored by:	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

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

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

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

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

Keywords provided by University Hospital, Rouen:

overactive neurogenic bladder

Study placed in the following topic categories:

Urinary Bladder, Neurogenic
Signs and Symptoms
Urinary Bladder, Overactive
Botulinum Toxins

Cystocele
Urologic Diseases
Urinary Bladder Diseases

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009