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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Botulinum Toxin A (Botox )


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overactive bladder with more than 3 episodes of urgency of urge incontinence per day

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Botulinum Toxin A (Botox )|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of urgency and urge incontinence episodes at 3 months after injection |  | at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive bladder, Urgency, Urge incontinence, Botulinum toxin A, Quality of life