认知行为疗法治疗女性膀胱过度活动症：一项随机对照试验的研究方案。
Cognitive behavioral therapy for overactive bladder in women: study protocol for a randomized controlled trial.
机构信息
Department of Urology, Kyoto University Graduate School of Medicine, 54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.
Department of Health Promotion and Human Behavior, Kyoto University School of Public Health, Kyoto, Japan.
出版信息
BMC Urol. 2020 Aug 20;20(1):129. doi: 10.1186/s12894-020-00697-0.
BACKGROUND
Overactive bladder (OAB) symptoms affect daily life by decreasing health-related quality of life (HRQol). However, there remain no very effective treatment for OAB. Pharmacotherapy is one of the best treatments, but it is not always efficient and may incur adverse events. Although behavioral therapy is another effective treatment, there are very few structured treatment manuals on how to prescribe behavioral therapy to treat OAB for whom. Cognitive behavioral therapy (CBT) is a psychotherapy consisting of structured sessions to solve problems with the collaborative empiricism between therapists and patients. OAB symptoms are supposed to worsen with cognitive distortion, and CBT is expected to be effective in treating OAB by modifying such cognitive processes. In this trial, we will evaluate the efficacy of CBT for OAB.
METHODS
A randomized, controlled, open-label, multicenter parallel-group superiority trial will be conducted. Participants with moderate to severe OAB symptoms with or without pharmacotherapy will be recruited and will be randomly allocated 1:1 to two different groups by minimization (age, baseline OAB severity, treatment status, types of intervention, and treating institutions). The intervention group will be prescribed an individual CBT program covering six techniques in 4 sessions (30 min each), with or without pharmacotherapy. The primary outcome is the change scores in an OAB-questionnaire (OAB-q) from baseline to the end of the trial (week 13). Secondary outcomes will include other patient reported outcome measures and the frequency volume chart. All analyses will be conducted on an intention-to-treat principle.
DISCUSSION
This trial will determine the efficacy of CBT to treat OAB using a rigorous methodology. The effectiveness of CBT with a structured manual may not only lead to a new treatment option for patients suffering from OAB symptoms, but may also reduce the social burden by OAB.
TRIAL REGISTRATION
UMIN-CTR Clinical Trial, CTR-UMIN000038513 . Registered on November 7, 2019.
背景
膀胱过度活动症（OAB）症状会降低健康相关生活质量（HRQol），从而影响日常生活。然而，目前仍没有针对 OAB 的非常有效的治疗方法。药物治疗是最佳治疗方法之一，但并不总是有效，并且可能会产生不良反应。尽管行为疗法是另一种有效的治疗方法，但针对 OAB 患者，针对如何开具行为治疗的结构化治疗手册却非常少。认知行为疗法（CBT）是一种心理治疗，由一系列结构化的治疗会议组成，以解决患者与治疗师之间的合作实证问题。OAB 症状被认为会随着认知扭曲而恶化，并且 CBT 通过改变这种认知过程有望对 OAB 有效。在这项试验中，我们将评估 CBT 对 OAB 的疗效。
方法
这将是一项随机、对照、开放标签、多中心平行组优效性试验。将招募患有中重度 OAB 症状的患者（无论是否接受药物治疗），并通过最小化（年龄、基线 OAB 严重程度、治疗状态、干预类型和治疗机构）将其 1:1 随机分配到两个不同的组。干预组将被开具一份个人 CBT 计划，涵盖六个技术，共 4 个疗程（每个疗程 30 分钟），可同时或不与药物治疗结合使用。主要结局是从基线到试验结束（第 13 周）时 OAB 问卷（OAB-q）的变化评分。次要结局将包括其他患者报告的结局测量和频尿量图表。所有分析均将基于意向治疗原则进行。
讨论
这项试验将使用严格的方法确定 CBT 治疗 OAB 的疗效。使用结构化手册的 CBT 的有效性不仅可能为患有 OAB 症状的患者提供新的治疗选择，而且还可能通过 OAB 减轻社会负担。
试验注册
UMIN-CTR 临床试验，CTR-UMIN000038513。于 2019 年 11 月 7 日注册。
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