Mirabegron versus Solifenacin in Children with Overactive Bladder: Prospective Randomized Single-Blind Controlled Trial

Abstract

<b><i>Purpose:</i></b> The purpose of this study is to investigate the efficacy and safety of mirabegron versus solifenacin in the treatment of newly diagnosed overactive bladder (OAB) in children. <b><i>Methods:</i></b> We conducted a prospective randomized controlled study on pediatric patients with newly diagnosed OAB. Patients were randomized into 3 groups: mirabegron (50 mg once daily) in group I, solifenacin (5 mg) in group II, and placebo in group III. Before starting our treatment and at the end of the 3 months course, we obtained a 3-day voiding diary. This diary included incontinence episode per day, mean voided volume per micturition, mean number of micturition per day, and post-void residual urine. Moreover, the parents/patients were asked to rate symptom relief, and the adverse events were recorded throughout the study period. <b><i>Results:</i></b> A total of 190 patients aged from 5 to 14 years completed this study. At the end of this trial, both groups I and II showed significant improvement versus placebo regarding our efficacy parameters with no significant difference between group I and II. The overall success rate based on assessment of symptom relief was significantly higher in the treated groups (87.5% in I and 90.2% in II) versus placebo (55.8%). Dry mouth was reported in 2.8, 10, and 0% and constipation in 2.8, 11.4, and 1.4% in group I, II, and III, respectively, without statistically significant difference between group I and placebo. However, there was a significant difference between group II and placebo regarding these side effects. <b><i>Conclusion:</i></b> Both mirabegron and solifenacin have comparable efficacy regarding the control of OAB symptoms in the newly diagnosed children, but mirabegrone seems to have less side effects.

The Effectiveness in Activating M-Type K+ Current Produced by Solifenacin ([(3R)-1-azabicyclo[2.2.2]octan-3-yl] (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate): Independent of Its Antimuscarinic Action

“…However, recent evidence has been reported showing that the treatment with SOL could be closely linked to an increased risk of the impairment in cognitive functions [20][21][22][23][24][25][26][27][28][29][30][31]. Therefore, it is pertinent to reappraise the mechanism of SOL actions on electrical behaviors in varying excitable cells, given that its growing clinical use occurs [6,32].…”

Mirabegron in the Management of Overactive Bladder Syndrome

“… 60 Similarly, a prospective, single-blind study comparing mirabegron 50 mg (n = 64), solifenacin 5 mg (n = 65), and placebo (n = 61), in children aged 5 to 14 years, who reported ongoing bothersome urgency symptoms after at least 3 months of behavioural therapy, reported comparable efficacy for both mirabegron and solifenacin. 61 There was a significant improvement in the number of incontinence episodes per day, mean number of voids per day, and mean void volume, in both groups, but the frequency of adverse effects was lower in those taking mirabegron.…”

Efficacy of solifenacin, mirabegron and combination therapy in children with daytime urinary incontinence (BeDry): Protocol for a randomized single-blinded controlled trial (Preprint)

“…The estimated for the sample size calculations are based on one placebo-controlled trial, prospective and retrospective studies [16][17][18][19][20] . We expect 15% of the children to have a complete response on treatment with low dose solifenacin 5 mg, and 15% of the children to have a complete response on treatment with low dose mirabegron 25 mg.…”

“…In the pediatric population, mirabegron is used off-label, either as monotherapy or in combination with antimuscarinics 12 13 . The efficacy of mirabegron compared to placebo has been elucidated among children 9 . Furthermore, the drug has high safety and tolerability in the pediatric population 23 .…”