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

This study has been terminated.
(the study has concluded normally;)
Sponsor:
Information provided by:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213577
First received: September 13, 2005
Last updated: March 3, 2008
Last verified: March 2008
  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 2

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:


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):
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 April 17, 2014