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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 23, 2015
Last verified: March 2015
  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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 23, 2015
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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016