Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder.
1 other identifier
interventional
160
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2005
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedStudy Start
First participant enrolled
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFebruary 17, 2011
March 1, 2007
4.4 years
October 3, 2005
February 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of urgency and urge incontinence episodes at 3 months after injection
at 3 months
Secondary Outcomes (12)
Number of micturition episodes on micturition chart per day
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
- +7 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Overactive bladder with more than 3 episodes of urgency of urge incontinence per day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
RAYMOND POINCARE Hospital
Garches, 92380, France
Related Publications (2)
Rajkumar GN, Small DR, Mustafa AW, Conn G. A prospective study to evaluate the safety, tolerability, efficacy and durability of response of intravesical injection of botulinum toxin type A into detrusor muscle in patients with refractory idiopathic detrusor overactivity. BJU Int. 2005 Oct;96(6):848-52. doi: 10.1111/j.1464-410X.2005.05725.x.
PMID: 16153215BACKGROUNDDenys P, Le Normand L, Ghout I, Costa P, Chartier-Kastler E, Grise P, Hermieu JF, Amarenco G, Karsenty G, Saussine C, Barbot F; VESITOX study group in France. Efficacy and safety of low doses of onabotulinumtoxinA for the treatment of refractory idiopathic overactive bladder: a multicentre, double-blind, randomised, placebo-controlled dose-ranging study. Eur Urol. 2012 Mar;61(3):520-9. doi: 10.1016/j.eururo.2011.10.028. Epub 2011 Oct 25.
PMID: 22036776DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre DENYS, MD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 3, 2005
First Posted
October 4, 2005
Study Start
November 1, 2005
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
February 17, 2011
Record last verified: 2007-03