Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder.
Information source: Assistance Publique - Hôpitaux de Paris
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Bladder (OAB)
Intervention: Botulinum Toxin A (Botox ) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s):
Pierre DENYS, MD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris
Overall contact:
Pierre DENYS, MD, Phone: +33(0)-1 47 10 70 72, Email: pierre.denys@rpc.aphp.fr
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Number of urgency and urge incontinence episodes at 3 months after injection
Secondary outcome: Number of micturition episodes on micturition chart per dayMean 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
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Overactive bladder with more than 3 episodes of urgency of urge incontinence per day
Locations and Contacts
Pierre DENYS, MD, Phone: +33(0)-1 47 10 70 72, Email: pierre.denys@rpc.aphp.fr
RAYMOND POINCARE Hospital, GARCHES 92380, France; Recruiting
Philippe DENYS, MD, Phone: +33(0)-1 47 10 70 72, Email: pierre.denys@rpc.aphp.fr
Additional Information
Related publications: 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.
Starting date: November 2005
Ending date: April 2007
Last updated: March 13, 2007
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