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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00231491
First received: October 3, 2005
Last updated: February 16, 2011
Last verified: March 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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

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

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
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: 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:
Additional 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
Study First Received: October 3, 2005
Last Updated: February 16, 2011
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:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014