Mirabegron与索利那新治疗儿童非神经源性膀胱过动症的疗效和安全性:一项随机对照试验。

IF 4.5 3区 医学 Q1 UROLOGY & NEPHROLOGY
Islam Mansour, Mahmoud Laymon, Ahmed Abdelhalim, Mohamed S Dawaba, Ahmed S El-Hefnawy
{"title":"Mirabegron与索利那新治疗儿童非神经源性膀胱过动症的疗效和安全性:一项随机对照试验。","authors":"Islam Mansour, Mahmoud Laymon, Ahmed Abdelhalim, Mohamed S Dawaba, Ahmed S El-Hefnawy","doi":"10.1590/S1677-5538.IBJU.2024.0425","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Non-neurogenic overactive bladder (OAB) is a common problem in children. Antimuscarinics have been widely used as first-line medical treatment. However, their frequent side effects necessitate searching for therapeutic alternatives. We aimed to assess the efficacy and safety of the beta 3 agonist, mirabegron.</p><p><strong>Materials and methods: </strong>A randomized controlled trial enrolled child with non-neurogenic OAB refractory to behavioral urotherapy. Patients were randomized to receive either Mirabegron 25/50 mg based on a 40-kg body weight cutoff or solifenacin 5 mg for 12 weeks. Patients were assessed using Dysfunctional Voiding Scoring System questionnaire (DVSS), 3-day voiding diary and uroflowmetry. Vital signs and adverse effects were recorded at baseline and follow-up. The study primary endpoint was ≥50% reduction of the baseline DVSS.</p><p><strong>Results: </strong>Among 128 patients screened, 72 patients (36 in each group) completed the study with a mean age of 9.2±2.3 years. Both groups had significant improvement of DVSS and voiding diary (p<0.001) at 12 weeks. In mirabegron group, 94.4% (34/36) had greater than 50% improvement of DVSS compared to 75% (27/36) of solifenacin group (P=0.02). Complete symptom resolution was observed in 22.2% (8/36) patients on mirabegron versus 8.3% (3/36) on solifenacin (P=0.1). Patients on mirabegron had less adverse effects (19.4% vs 47.2%; p=0.01).</p><p><strong>Conclusion: </strong>Mirabegron is more effective with fewer adverse effects than solifenacin for treatment of children with OAB. Mirabegron treatment improves daytime symptoms and nocturnal enuresis with less risk of constipation. It may be considered as first-line pharmacotherapy in this patient population.</p>","PeriodicalId":49283,"journal":{"name":"International Braz J Urol","volume":"51 2","pages":""},"PeriodicalIF":4.5000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11884633/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Mirabegron Compared to Solifenacin in Treatment of Non-neurogenic Overactive Bladder in Children: A Randomized Controlled Trial.\",\"authors\":\"Islam Mansour, Mahmoud Laymon, Ahmed Abdelhalim, Mohamed S Dawaba, Ahmed S El-Hefnawy\",\"doi\":\"10.1590/S1677-5538.IBJU.2024.0425\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Non-neurogenic overactive bladder (OAB) is a common problem in children. Antimuscarinics have been widely used as first-line medical treatment. However, their frequent side effects necessitate searching for therapeutic alternatives. We aimed to assess the efficacy and safety of the beta 3 agonist, mirabegron.</p><p><strong>Materials and methods: </strong>A randomized controlled trial enrolled child with non-neurogenic OAB refractory to behavioral urotherapy. Patients were randomized to receive either Mirabegron 25/50 mg based on a 40-kg body weight cutoff or solifenacin 5 mg for 12 weeks. Patients were assessed using Dysfunctional Voiding Scoring System questionnaire (DVSS), 3-day voiding diary and uroflowmetry. Vital signs and adverse effects were recorded at baseline and follow-up. The study primary endpoint was ≥50% reduction of the baseline DVSS.</p><p><strong>Results: </strong>Among 128 patients screened, 72 patients (36 in each group) completed the study with a mean age of 9.2±2.3 years. Both groups had significant improvement of DVSS and voiding diary (p<0.001) at 12 weeks. In mirabegron group, 94.4% (34/36) had greater than 50% improvement of DVSS compared to 75% (27/36) of solifenacin group (P=0.02). Complete symptom resolution was observed in 22.2% (8/36) patients on mirabegron versus 8.3% (3/36) on solifenacin (P=0.1). Patients on mirabegron had less adverse effects (19.4% vs 47.2%; p=0.01).</p><p><strong>Conclusion: </strong>Mirabegron is more effective with fewer adverse effects than solifenacin for treatment of children with OAB. Mirabegron treatment improves daytime symptoms and nocturnal enuresis with less risk of constipation. It may be considered as first-line pharmacotherapy in this patient population.</p>\",\"PeriodicalId\":49283,\"journal\":{\"name\":\"International Braz J Urol\",\"volume\":\"51 2\",\"pages\":\"\"},\"PeriodicalIF\":4.5000,\"publicationDate\":\"2025-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11884633/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Braz J Urol\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1590/S1677-5538.IBJU.2024.0425\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Braz J Urol","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1590/S1677-5538.IBJU.2024.0425","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
引用次数: 0

摘要

目的:非神经源性膀胱过动症(OAB)是儿童的常见病。抗菌药物已广泛应用于一线医疗。然而,它们频繁的副作用需要寻找治疗替代方案。我们的目的是评估β 3激动剂mirabegron的有效性和安全性。材料和方法:一项随机对照试验,招募了对行为泌尿治疗难治的非神经源性OAB儿童。患者随机接受Mirabegron 25/ 50mg基于40公斤体重临界值或索利那新5mg,持续12周。采用功能障碍排尿评分系统问卷(DVSS)、3天排尿日记和尿流仪对患者进行评估。在基线和随访时记录生命体征和不良反应。研究的主要终点是基线DVSS降低≥50%。结果:筛选的128例患者中,72例(每组36例)完成研究,平均年龄9.2±2.3岁。两组患儿DVSS及排尿日记均有显著改善(p)结论:美拉贝格龙治疗OAB患儿疗效显著,不良反应少。Mirabegron治疗可改善日间症状和夜间遗尿,减少便秘风险。这类患者可考虑将其作为一线药物治疗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Efficacy and Safety of Mirabegron Compared to Solifenacin in Treatment of Non-neurogenic Overactive Bladder in Children: A Randomized Controlled Trial.

Efficacy and Safety of Mirabegron Compared to Solifenacin in Treatment of Non-neurogenic Overactive Bladder in Children: A Randomized Controlled Trial.

Efficacy and Safety of Mirabegron Compared to Solifenacin in Treatment of Non-neurogenic Overactive Bladder in Children: A Randomized Controlled Trial.

Purpose: Non-neurogenic overactive bladder (OAB) is a common problem in children. Antimuscarinics have been widely used as first-line medical treatment. However, their frequent side effects necessitate searching for therapeutic alternatives. We aimed to assess the efficacy and safety of the beta 3 agonist, mirabegron.

Materials and methods: A randomized controlled trial enrolled child with non-neurogenic OAB refractory to behavioral urotherapy. Patients were randomized to receive either Mirabegron 25/50 mg based on a 40-kg body weight cutoff or solifenacin 5 mg for 12 weeks. Patients were assessed using Dysfunctional Voiding Scoring System questionnaire (DVSS), 3-day voiding diary and uroflowmetry. Vital signs and adverse effects were recorded at baseline and follow-up. The study primary endpoint was ≥50% reduction of the baseline DVSS.

Results: Among 128 patients screened, 72 patients (36 in each group) completed the study with a mean age of 9.2±2.3 years. Both groups had significant improvement of DVSS and voiding diary (p<0.001) at 12 weeks. In mirabegron group, 94.4% (34/36) had greater than 50% improvement of DVSS compared to 75% (27/36) of solifenacin group (P=0.02). Complete symptom resolution was observed in 22.2% (8/36) patients on mirabegron versus 8.3% (3/36) on solifenacin (P=0.1). Patients on mirabegron had less adverse effects (19.4% vs 47.2%; p=0.01).

Conclusion: Mirabegron is more effective with fewer adverse effects than solifenacin for treatment of children with OAB. Mirabegron treatment improves daytime symptoms and nocturnal enuresis with less risk of constipation. It may be considered as first-line pharmacotherapy in this patient population.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
International Braz J Urol
International Braz J Urol UROLOGY & NEPHROLOGY-
CiteScore
4.60
自引率
21.60%
发文量
246
审稿时长
6-12 weeks
期刊介绍: Information not localized
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信