Department of Urology, Division of Pediatric Urology, Radboud University Medical Center, Amalia Children's Hospital, Geert Grooteplein Zuid 10, Nijmegen, 6500 HB, The Netherlands.
Department of Medical Psychology and Social Work, Wilhelmina Children's Hospital Utrecht, Utrecht, The Netherlands.
Trials. 2022 Aug 13;23(1):648. doi: 10.1186/s13063-022-06600-6.
Lower urinary tract dysfunction or functional urinary incontinence is a common condition with a prevalence up to 21% between 6 and 8 year-old children. It is associated with an impaired quality of life, lower self-esteem, and social stigmatization. Urotherapy is the first treatment of choice for functional daytime urinary incontinence (DUI) in children. Alarm therapy can be a part of urotherapy as it provides the child adequate feedback on wetting accidents. Current alarm systems notify either at a set interval or give a notification when wetting has already occurred to prompt the child to go to the toilet. These alarms do not teach the child the interpretation of the bladder sensation preceding wetting accidents. A new wearable bladder sensor, the SENS-U, recently became available. This is a relative small, wireless ultrasonic sensor, which continuously monitors bladder filling. The SENS-U is able to provide an alarm at the exact moment voiding is warranted. It facilitates the child to learn the sensation of bladder filling preceding voiding in an easier way, increasing the learning curve throughout treatment. Its additional effect in urotherapy on continence and cost-effectiveness is to be determined.
METHODS/DESIGN: This is a multi-center clinical superiority parallel-group randomized controlled trial including a total of 480 children. Participants between 6 and 16 years of age with functional DUI in which urotherapy is offered as the next treatment of choice are eligible. Four centers, two academic hospitals, and two general care (peripheral) centers are participating. Participants will be randomized at a 1:1:1 ratio into three groups: urotherapy (care as usual), urotherapy with the SENS-U added for 3 consecutive weeks throughout the training, or urotherapy with a SHAM device for 3 weeks. The primary outcome is number of wetting accidents per week after 3 months of training, compared between the SENS-U and the SHAM device. The magnitude of the placebo effect will be assessed by comparing the results of the SHAM group versus the control (care as usual) group.
To our knowledge, this is the first trial studying not only the effect but also the cost-effectiveness of alarm interventions as commonly added in urotherapy.
ISRCTN44345202 . Registered on March 2022.
下尿路功能障碍或功能性尿失禁是一种常见病症，6 至 8 岁儿童的患病率高达 21%。它与生活质量受损、自尊心下降和社会污名化有关。尿疗是治疗儿童功能性日间尿失禁（DUI）的首选治疗方法。警报疗法可以作为尿疗的一部分，因为它可以为孩子提供关于遗尿事故的充分反馈。目前的警报系统要么按设定的时间间隔发出通知，要么在已经发生湿时发出通知，以提示孩子去厕所。这些警报器并不能教导孩子在遗尿事故发生前对膀胱感觉的解释。最近，一种新的可穿戴式膀胱传感器 SENS-U 问世。这是一种相对较小的无线超声传感器，可连续监测膀胱充盈情况。SENS-U 能够在需要排尿的确切时刻发出警报。它使孩子更容易以一种简单的方式学习在排尿前膀胱充盈的感觉，从而增加治疗过程中的学习曲线。它在尿疗中的额外效果，包括对控尿和成本效益的影响，有待确定。
方法/设计：这是一项多中心临床优势平行组随机对照试验，共纳入 480 名儿童。参与者为 6 至 16 岁的功能性 DUI 儿童，他们将接受尿疗作为下一个治疗选择。有四个中心，两个学术医院和两个普通护理（外围）中心参与。参与者将以 1:1:1 的比例随机分为三组：尿疗（常规护理）、尿疗加 SENS-U 连续 3 周治疗、或尿疗加 SHAM 装置 3 周。主要结局是 3 个月训练后每周湿尿次数，比较 SENS-U 与 SHAM 装置的差异。通过比较 SHAM 组与对照组（常规护理）的结果，评估安慰剂效应的大小。
据我们所知，这是首次研究警报干预的效果和成本效益的试验，这些干预措施通常作为尿疗的一部分添加。
ISRCTN44345202。于 2022 年 3 月注册。
