Abstract / Summary
Erectile dysfunction (ED) is a prevalent and impactful sequelae following robotic-assisted radical prostatectomy (RARP), significantly diminishing patients’ quality of life. Although electroacupuncture is widely employed for ED management in China, robust evidence supporting its efficacy specifically for post-RARP ED remains scarce. This study aims to evaluate the efficacy and safety of electroacupuncture versus a sham procedure in prostatic cancer (PCa) survivors after RARP. A total of 114 participants will be randomized in a 1:1 ratio to receive either electroacupuncture (EA) or sham electroacupuncture (SEA). All participants will undergo 24 treatment sessions over 8 weeks, followed by an 8-week observational follow-up period. The primary outcome is the International Index of Erectile Function (IIEF-5) score. Secondary outcomes include the Erectile Hardness Scale (EHS), sexual encounter profile (SEP) questions 2 and 3, serum testosterone levels, penile hemodynamic parameters, the Hospital Anxiety and Depression Scale (HADS), and a visual analogue scale (VAS) for patient-reported subjective efficacy. Serum testosterone and penile hemodynamics will be assessed at baseline, week 8, and week 16; all other outcomes will be evaluated at baseline and weeks 4, 8, 12, and 16. All analyses will adhere to the intention-to-treat principle. This rigorously designed, sham-controlled trial aims to address the current evidence gap regarding electroacupuncture for post-prostatectomy erectile dysfunction. By employing high methodological standards, it seeks to generate unbiased efficacy and safety data. If proven effective, the findings would support the integration of acupuncture as a viable non-pharmacological option within post-surgical rehabilitation protocols. International Traditional Medicine Clinical Trial Registry (registration number: ITMCTR2025001479).