Svendsen Ann-Kristine Mandøe, Hagstrøm Søren, Kamperis Konstantinos, Andersen Anna Elizabeth, Henneberg Nanna Celina, Van Batavia Jason, Olesen Anne Estrup, Borch Luise
Department of Pediatrics and Adolescent Medicine, Gødstrup Hospital, Herning, Denmark.
NIDO Centre for Research and Education, Gødstrup Hospital, Herning, Denmark.
JMIR Res Protoc. 2025 Jul 9;14:e63226. doi: 10.2196/63226.
To the best of our knowledge, no studies have investigated the withdrawal strategy of pharmacological treatment with solifenacin or mirabegron in children diagnosed with urinary incontinence who have achieved continence on pharmacotherapy.
The primary objective is to investigate if abrupt withdrawal versus gradual withdrawal of pharmacotherapy (solifenacin or mirabegron) influences the risk of recurrence of incontinence, assessed by a self-reported 14-day calendar of incontinence episodes.
Children aged 5-14 years diagnosed with urinary incontinence, treated with pharmacotherapy of solifenacin or mirabegron and ready for withdrawal, will be randomized 1:1 to either abrupt or gradual withdrawal, according to the medical treatment that the child is receiving. The primary outcome measure is the recurrence of incontinence after withdrawal, 1 month after initiation of withdrawal of the physician-prescribed medication, assessed by a self-reported 14-day calendar of incontinence episodes. In addition, recurrence of incontinence after 3, 6, and 12 months after initiation of withdrawal will be measured. The hypothesis that gradual withdrawal is superior to abrupt withdrawal regarding the risk of recurrence of incontinence will be analyzed by logistic regression.
Recruitment began at the end of May 2024 and will continue until 216 patients are included, which is expected by December 2027. As of February 2025, a total of 25 participants are included.
The results are expected to influence the withdrawal strategy of pharmacological treatment with solifenacin or mirabegron in children with daytime urinary incontinence.
ClinicalTrials.gov NCT06465576; https://clinicaltrials.gov/search?term=NCT06465576.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63226.
据我们所知，尚无研究调查过已通过药物治疗实现尿失禁控制的儿童，停用索利那新或米拉贝隆药物治疗的策略。
主要目的是研究药物治疗（索利那新或米拉贝隆）突然停药与逐渐停药是否会影响尿失禁复发风险，通过自我报告的14天尿失禁发作日历进行评估。
年龄在5至14岁、诊断为尿失禁、接受索利那新或米拉贝隆药物治疗且准备停药的儿童，将根据其正在接受的药物治疗按1:1随机分为突然停药组或逐渐停药组。主要结局指标是在医生开出的药物停药开始1个月后，通过自我报告的14天尿失禁发作日历评估停药后尿失禁的复发情况。此外，还将测量停药开始后3、6和12个月时尿失禁的复发情况。关于尿失禁复发风险，逐渐停药优于突然停药这一假设将通过逻辑回归进行分析。
招募工作于2024年5月底开始，将持续至纳入216名患者，预计在2027年12月完成。截至2025年2月，共纳入25名参与者。
预期结果将影响白天尿失禁儿童停用索利那新或米拉贝隆药物治疗的策略。
ClinicalTrials.gov NCT06465576；https://clinicaltrials.gov/search?term=NCT06465576。
国际注册报告识别码（IRRID）：DERR1-10.2196/63226。
