Abstract | BACKGROUND: 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.
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Authors | Pierre 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 |
Journal | European urology
(Eur Urol)
Vol. 61
Issue 3
Pg. 520-9
(Mar 2012)
ISSN: 1873-7560 [Electronic] Switzerland |
PMID | 22036776
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved. |
Chemical References |
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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)
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