To evaluate the efficacy and safety of onabotulinumtoxinA (botulinum toxin type A) 100 U in patients with overactive bladder and urinary incontinence.
This was a phase III, randomized, double-blind, placebo-controlled trial in Japanese patients who were inadequately managed with overactive bladder medications (anticholinergics and/or β3 -adrenergic receptor agonists). Eligible patients were randomized 1:1 to receive a single dose of either onabotulinumtoxinA or placebo into the detrusor muscle (n = 124 each). The primary end-point was the change in the number of daily urinary incontinence episodes at week 12 from baseline. Secondary end-points included volume voided per micturition, other symptomatic measures (urinary urgency incontinence, micturition, urgency and nocturia) and patient-reported outcomes.
In the onabotulinumtoxinA group, there was a significantly greater decrease from baseline in the mean number of daily urinary incontinence episodes compared with the placebo group (2.16; P < 0.001), and significantly greater improvement for all secondary end-points (P < 0.05). Urinary tract infection, dysuria, urinary retention and post-void residual urine volume increased represented adverse events occurring at a higher rate in the onabotulinumtoxinA group. The majority of these were mild or moderate in severity.
Statistically significant and clinically relevant improvements in symptoms and patient-reported outcomes, and tolerability were seen in patients with overactive bladder and urinary incontinence who had been inadequately managed with overactive bladder medications after using onabotulinumtoxinA.
International journal of urology : official journal of the Japanese Urological Association. 2020 Jan 20 [Epub ahead of print]
Osamu Yokoyama, Masashi Honda, Tomonori Yamanishi, Yuki Sekiguchi, Kenji Fujii, Takashi Nakayama, Takao Mogi
Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan., Department of Urology, Tottori University Faculty of Medicine, Tottori, Japan., Department of Urology, Dokkyo Medical University, Tochigi, Japan., Yokohama Motomachi Women's Clinic LUNA, Kanagawa, Japan., Medicines Development, Japan Development Division, GlaxoSmithKline, Tokyo, Japan., Biomedical Data Sciences Department, Japan Development Division, GlaxoSmithKline, Tokyo, Japan.