Efficacy of acupuncture in the treatment of psychogenic erectile dysfunction: study protocol for a randomized control trial

Acupuncture is widely used in China for various conditions. Recently, due to the limitations of conventional treatment, many patients with psychogenic erectile dysfunction (ED) tend to choose acupuncture therapy, which is more commonly applied in countries such as China. The present clinical trial protocol aimed to initially verify the efficacy and safety of acupuncture in the treatment of psychogenic ED. Our study is a prospective, randomized control trial (RCT). The protocol for this RCT is based on the standard protocol items: recommendations for interventional trials (SPIRIT) 2013 statement. After the participants who met the inclusion and exclusion criteria sign an informed consent form, the investigator will schedule them for the trial. Patients will be randomly divided into two groups (acupuncture and sham acupuncture). Both groups will receive 18 sessions of interventions for 6 continuous weeks and will be followed up for 10 weeks. At five time points (0, 2, 4, 6 and 10 weeks), We will measure the primary and secondary outcomes. Emerging evidence support acupuncture therapy for improving male sexual function and its application in andrology. However, its efficacy on patients diagnosed with psychogenic ED has not been extensively studied. With our study, we anticipate to fill the knowledge gap in acupuncture as treatment for psychogenic ED.