McMaster Pediatric Surgery Research Collaborative (KJ, CL, JD), Hamilton, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University (LHB, FF), Hamilton, Ontario, Canada; Clinical Urology Research Enterprise Program, McMaster Children's Hospital (LHB, MR, FF, KJ, NB, JD, AJL), Hamilton, Ontario, Canada; Division of Urology, Hospital for Sick Children (AJL), Toronto, Ontario, Canada.
McMaster Pediatric Surgery Research Collaborative (KJ, CL, JD), Hamilton, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University (LHB, FF), Hamilton, Ontario, Canada; Clinical Urology Research Enterprise Program, McMaster Children's Hospital (LHB, MR, FF, KJ, NB, JD, AJL), Hamilton, Ontario, Canada; Division of Urology, Hospital for Sick Children (AJL), Toronto, Ontario, Canada.
J Urol. 2017 Mar;197(3 Pt 2):877-884. doi: 10.1016/j.juro.2016.08.089. Epub 2016 Aug 26.
We evaluated whether an animated bladder training video was as effective as standard individual urotherapy in improving bladder/bowel symptoms.
Patients 5 to 10 years old who scored greater than 11 on the bladder/bowel Vancouver questionnaire were included in a noninferiority randomized, controlled trial. Children with vesicoureteral reflux, neuropathic bladder, learning disabilities, recent urotherapy or primary nocturnal enuresis were excluded from analysis. Patients were randomly assigned to receive standard urotherapy or watch a bladder training video in clinic using centralized blocked randomization schemes. Bladder/bowel symptoms were evaluated at baseline and 3-month followup by intent to treat analysis. A sample size of 150 patients ensured a 3.5 difference in mean symptomology scores between the groups, which was accepted as the noninferiority margin.
Of 539 screened patients 173 (37%) were eligible for study and 150 enrolled. A total of 143 patients (95%) completed the trial, 5 (4%) were lost to followup and 2 (1%) withdrew. Baseline characteristics were similar between the groups. Baseline mean ± SD symptomology scores were 19.9 ± 5.5 for the bladder training video and 19.7 ± 6.0 for standard urotherapy. At 3 months the mean symptomology scores for the bladder training video and standard urotherapy were reduced to 14.4 ± 6.5 and 13.8 ± 6.0, respectively (p = 0.54). The mean difference was 0.6 (95% CI -1.4-2.6). The upper 95% CI limit of 2.6 did not exceed the preset 3.5 noninferiority margin.
The bladder training video was not inferior to standard urotherapy in reducing bladder/bowel symptoms in children 5 to 10 years old. The video allows families to have free access to independently review bladder training concepts as often as necessary.
我们评估了动画膀胱训练视频是否与标准个体尿疗法一样有效，以改善膀胱/肠道症状。
本研究纳入了膀胱/肠道温哥华问卷评分大于 11 分的 5 至 10 岁患者，进行非劣效性随机对照试验。排除有膀胱输尿管反流、神经性膀胱、学习障碍、近期尿疗或原发性夜间遗尿的患者。患者随机分配接受标准尿疗或在诊所观看膀胱训练视频，采用中心化分组随机化方案。采用意向治疗分析在基线和 3 个月随访时评估膀胱/肠道症状。150 例患者的样本量确保了两组间平均症状评分有 3.5 的差异，这被认为是非劣效性边界。
在筛查的 539 例患者中，有 173 例（37%）符合研究条件，有 150 例入组。共有 143 例（95%）患者完成了试验，5 例（4%）失访，2 例（1%）退出。两组间的基线特征相似。膀胱训练视频组和标准尿疗组的基线平均（±SD）症状评分分别为 19.9±5.5 和 19.7±6.0。3 个月时，膀胱训练视频组和标准尿疗组的平均症状评分分别降至 14.4±6.5 和 13.8±6.0（p=0.54）。平均差值为 0.6（95%CI-1.4-2.6）。95%CI 的上限 2.6 不超过预设的 3.5 非劣效性边界。
在 5 至 10 岁儿童中，膀胱训练视频在减轻膀胱/肠道症状方面并不劣于标准尿疗。该视频允许家庭自由访问并根据需要反复独立查看膀胱训练概念。
