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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Number of urgency and urge incontinence episodes at 3 months after injection
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Overactive bladder with more than 3 episodes of urgency of urge incontinence per day
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of urgency and urge incontinence episodes at 3 months after injection
Time Frame: at 3 months
Secondary Outcomes
- 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
- 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