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Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00231491
First Posted: October 4, 2005
Last Update Posted: February 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assistance Publique - Hôpitaux de Paris
  Purpose
Overactive bladder induce urgency, urge incontinence, nocturia and pollakiuria. This condition is often resistant to anticholinergic drugs used as a first line treatment for this purpose. Moreover muscarinic side effects (constipation, mouth dryness) often limits the use of those treatments. This study is designed to evaluate the efficacy and safety of botulinum toxin A injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.

Condition Intervention Phase
Overactive Bladder Drug: Botulinum Toxin A (Botox ) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder (OAB). A Multicenter Phase II, Randomized, Double-blind, Placebo Controlled 6 Month Study . VESITOX

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Number of urgency and urge incontinence episodes at 3 months after injection [ Time Frame: at 3 months ]

Secondary Outcome Measures:
  • Number of micturition episodes on micturition chart per day [ Time Frame: per day ]
  • Mean value of volume of urine per micturition
  • Mean delay between urgency and leakage Quality of life improvement by Iqol and EuroQol (EQ-5D)
  • Urodynamic parameters : Volume at first contraction, volume at first desire to void, volume at urgency, maximal bladder capacity, maximal detrusor pressure
  • Number of pads used per day
  • Number of patients with less than 3 episodes per day of leakages by urge incontinence or urgency per day
  • Residual volume of urine after flowmetry
  • Maximal flow
  • Visual analogic scale for pain for procedure
  • Biologic modifications
  • Ultrasound of kidneys
  • Toxin A antibodies

Enrollment: 160
Study Start Date: November 2005
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Detailed Description:
This study is designed to evaluate the efficacy and safety of botulinum toxin A injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.
  Eligibility

Information from the National Library of Medicine

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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:

  • Overactive bladder with more than 3 episodes of urgency of urge incontinence per day
  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): NCT00231491


Locations
France
RAYMOND POINCARE Hospital
Garches, France, 92380
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Pierre DENYS, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amel OUSLIMANI, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00231491     History of Changes
Other Study ID Numbers: P030438
First Submitted: October 3, 2005
First Posted: October 4, 2005
Last Update Posted: February 17, 2011
Last Verified: March 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Overactive bladder
Urgency
Urge incontinence
Botulinum toxin A
Quality of life

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents