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

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ClinicalTrials.gov Identifier: NCT00213577
Recruitment Status : Terminated (the study has concluded normally;)
First Posted : September 21, 2005
Last Update Posted : March 24, 2015
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Overactive Bladder Drug: type A botulinum toxin Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : December 2003
Primary Completion Date : September 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. complete urinary continence at baseline, and days 30, 90, 180, and 360

Secondary Outcome Measures :
  1. number of mictions or self catheterizations a day
  2. number of leakages, urgency adverse events
  3. guarding times
  4. urodynamics: bladder capacity, reflex volume, residual maximal capacity detrusor pressure, flow detrusor pressure

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015

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