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JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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.
European Urology 2012 March
BACKGROUND: 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.
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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