Background: 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.

Methods: 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.

Discussion: This study will investigate the effect of a mobile-based CBT intervention on patients with PE.

Trial registration: Chinese Clinical Trial Registry (ChiCTR2300070581).