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Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder.
This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, March 2007
First Received: October 3, 2005   Last Updated: March 13, 2007   History of Changes
Sponsor: Assistance Publique - Hôpitaux de Paris
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00231491
  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 (OAB)
Drug: Botulinum Toxin A (Botox )
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Secondary Outcome Measures:
  • Number of micturition episodes on micturition chart 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

Estimated Enrollment: 160
Study Start Date: November 2005
Estimated Study Completion Date: April 2007
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Overactive bladder with more than 3 episodes of urgency of urge incontinence per day
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231491

Contacts
Contact: Pierre DENYS, MD +33(0)-1 47 10 70 72 pierre.denys@rpc.aphp.fr

Locations
France
RAYMOND POINCARE Hospital Recruiting
GARCHES, France, 92380
Contact: Philippe DENYS, MD     +33(0)-1 47 10 70 72     pierre.denys@rpc.aphp.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Pierre DENYS, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Study ID Numbers: P030438, AOM03111
Study First Received: October 3, 2005
Last Updated: March 13, 2007
ClinicalTrials.gov Identifier: NCT00231491     History of Changes
Health Authority: France: Ministry of Health

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

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 February 08, 2010