The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Hangzhou Kang Ming Information Technology Co., Ltd, Hangzhou, China.
PLoS One. 2023 Dec 27;18(12):e0295663. doi: 10.1371/journal.pone.0295663. eCollection 2023.
Premature ejaculation (PE) is one of the most common male sexual dysfunctions, with a prevalence of about 4%-39% in the Chinese population. Studies have shown that a variety of biological factors can lead to premature ejaculation, such as central nervous system disorders, hypersensitivity of the penis head, and psychological factors. Based on clinical experience, psychological counseling and education of patients and partners should be ranked as the first priority when treating PE. Cognitive behavioral therapy (CBT) addresses emotional, behavioral, and cognitive disorders by altering beliefs and actions. It has also been demonstrated to be clinically useful in treating a number of diseases. The purpose of this trial is to evaluate the efficacy of a mobile-based CBT intervention on patients with PE compared to conventional routine treatment.
This study is a prospective randomized controlled trial that will be conducted from May 2023 to Dec 2024 at ten hospitals, primarily including the First Affiliated Hospital of Sun Yat-sen University with an 8-week follow-up. The clinical trial central randomization system will be used to create and implement the specific randomization method. Baseline data of both groups will be measured and collected. The premature ejaculation diagnostic tool (PEDT) and the female sexual distress scale-revised for premature ejaculation (FSDS-R-PE) will be collected on the first day, 28±2 days, and 56±2 days during the intervention period, and the intravaginal ejaculatory latency time (IELT) will be measured in both groups. The Shapiro-Wilk test will be used for normality testing. Pearson correlation analysis will be used for correlation analysis. Differences between groups will be compared using analysis of variance or exact probability calculations.
This study will investigate the effect of a mobile-based CBT intervention on patients with PE.
Chinese Clinical Trial Registry (ChiCTR2300070581).
早泄（PE）是最常见的男性性功能障碍之一，中国人群的患病率约为 4%-39%。研究表明，多种生物学因素可导致早泄，如中枢神经系统紊乱、龟头敏感度增加和心理因素等。基于临床经验，在治疗 PE 时，应将对患者和伴侣的心理疏导和教育列为首要任务。认知行为疗法（CBT）通过改变信念和行为来解决情绪、行为和认知障碍。它在治疗多种疾病方面也已被证明具有临床应用价值。本试验旨在评估基于移动设备的 CBT 干预对 PE 患者的疗效，与常规常规治疗相比。
本研究是一项前瞻性随机对照试验，将于 2023 年 5 月至 2024 年 12 月在十家医院进行，主要包括中山大学附属第一医院，随访 8 周。将使用临床试验中央随机化系统来创建和实施具体的随机化方法。将对两组的基线数据进行测量和收集。在干预期间的第一天、28±2 天和 56±2 天，将使用早泄诊断工具（PEDT）和修订后的女性性困扰量表-早泄版（FSDS-R-PE）收集数据，同时测量两组的阴道内射精潜伏期时间（IELT）。将使用 Shapiro-Wilk 检验进行正态性检验。Pearson 相关分析将用于相关性分析。使用方差分析或确切概率计算比较组间差异。
本研究将调查基于移动设备的 CBT 干预对 PE 患者的影响。
中国临床试验注册中心（ChiCTR2300070581）。
