Clinical trial NCT00231491: Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Keywords: Overactive bladder
Urgency
Urge incontinence
Botulinum toxin A
Quality of life
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-10-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Overactive bladder with more than 3 episodes of urgency of urge incontinence per day

Primary outcomes:
measure: Number of urgency and urge incontinence episodes at 3 months after injection
timeFrame: at 3 months
Secondary outcomes:
measure: Number of micturition episodes on micturition chart per day
timeFrame: per day
measure: Mean value of volume of urine per micturition
measure: Mean delay between urgency and leakage Quality of life improvement by Iqol and EuroQol (EQ-5D)
measure: Urodynamic parameters : Volume at first contraction, volume at first desire to void, volume at urgency, maximal bladder capacity, maximal detrusor pressure
measure: Number of pads used per day
measure: Number of patients with less than 3 episodes per day of leakages by urge incontinence or urgency per day
measure: Residual volume of urine after flowmetry
measure: Maximal flow
measure: Visual analogic scale for pain for procedure
measure: Biologic modifications
measure: Ultrasound of kidneys
measure: Toxin A antibodies
Other outcomes:
Locations:
city: Garches
country: France
facility: RAYMOND POINCARE Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pierre DENYS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Denys 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.