HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

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.

AbstractBACKGROUND:
In the treatment of patients with idiopathic overactive bladder (iOAB), high doses of botulinum toxin type A (BoNTA) were often associated with complications resulting from high postvoid residuals (PVR), leading to clean intermittent catheterisation (CIC) and urinary tract infections (UTI).
OBJECTIVE:
Evaluate the efficacy and tolerability of low doses of onabotulinumtoxinA compared to placebo in patients with iOAB.
DESIGN, SETTING, AND PARTICIPANTS:
Between 2005 and 2009, adults with persistent iOAB were included in a prospective, randomised, double-blind, placebo-controlled comparative trial.
INTERVENTION:
Patients were randomised to undergo a single intradetrusor injection procedure of either placebo or onabotulinumtoxinA (50 U, 100 U or 150 U).
MEASUREMENTS:
The initial evaluations (ie, clinical and urodynamic variables as well as quality of life [QoL]) were repeated at day 8 and months 1, 3, 5, and 6.
RESULTS AND LIMITATIONS:
Ninety-nine patients were included in the efficacy analysis. Three months after the procedure, we observed>50% improvement versus baseline in urgency and urge urinary incontinence (UUI) in 65% and 56% of patients who respectively received 100 U (p=0.086) and 150 U (p=0.261) BoNTA injections and >75% improvement in 40% of patients of both groups (100 U [p=0.058] and 150 U [p=0.022]). Complete continence was observed in 55% and 50% patients after 100 U and 150 U BoNTA treatment, respectively, at month 3. Frequency symptoms and QoL improved up to the 6-mo visit. We observed only three patients with a PVR>200 ml in the 150 U group and a few UTIs.
CONCLUSIONS:
100 U and 150 U BoNTA injections were well tolerated and have both shown to improve symptoms and QoL in patients with iOAB. Nevertheless, 100 U injections showed a reasonable efficacy, with a lower risk of high PVR.
TRIAL REGISTRATION:
ClinicalTrials.gov NCT00231491.
AuthorsPierre Denys, Loïc Le Normand, Idir Ghout, Pierre Costa, Emmanuel Chartier-Kastler, Philippe Grise, Jean-François Hermieu, Gérard Amarenco, Gilles Karsenty, Christian Saussine, Frédéric Barbot, VESITOX study group in France
JournalEuropean urology (Eur Urol) Vol. 61 Issue 3 Pg. 520-9 (Mar 2012) ISSN: 1873-7560 [Electronic] Switzerland
PMID22036776 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Chemical References
  • Botulinum Toxins, Type A
Topics
  • Aged
  • Botulinum Toxins, Type A (administration & dosage, adverse effects)
  • Female
  • Humans
  • Male
  • Middle Aged
  • Quality of Life
  • Treatment Outcome
  • Urinary Bladder, Overactive (drug therapy)
  • Urinary Incontinence, Urge (drug therapy)

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: