Urology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.
Urol Int. 2021;105(11-12):1011-1017. doi: 10.1159/000515992. Epub 2021 May 19.
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.
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.
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.
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.
本研究旨在探讨米拉贝隆与索利那新治疗新诊断的儿童膀胱过度活动症（OAB）的疗效和安全性。
我们对新诊断为 OAB 的儿科患者进行了前瞻性随机对照研究。患者随机分为 3 组：米拉贝隆（50mg 每日 1 次）组 I、索利那新（5mg）组 II 和安慰剂组 III。在开始治疗前和 3 个月疗程结束时，我们获得了 3 天的排尿日记。该日记包括每天失禁发作次数、每次排尿量、每天排尿次数和残余尿量。此外，父母/患者被要求评估症状缓解情况，并在整个研究期间记录不良反应。
共有 190 名年龄在 5 至 14 岁的患者完成了本研究。在试验结束时，与安慰剂组相比，I 组和 II 组在我们的疗效参数方面均显示出显著改善，且 I 组和 II 组之间无显著差异。基于症状缓解评估的总体成功率在治疗组（I 组为 87.5%，II 组为 90.2%）显著高于安慰剂组（55.8%）。口干在 I 组、II 组和安慰剂组中的发生率分别为 2.8%、10%和 0%，便秘在 I 组、II 组和安慰剂组中的发生率分别为 2.8%、11.4%和 1.4%，I 组与安慰剂组之间无统计学差异。然而，在这些副作用方面，II 组与安慰剂组之间存在显著差异。
米拉贝隆和索利那新在控制新诊断儿童的 OAB 症状方面具有相当的疗效，但米拉贝隆的副作用似乎较少。
