Efficacy of sacral nerve root magnetic stimulation in primary premature ejaculation: mechanistic and clinical analysis

BACKGROUND: Primary premature ejaculation (PPE) is a common lifelong sexual disorder that adversely affects sexual satisfaction and quality of life (QoL), and current treatments have limitations in efficacy, tolerability, or durability. AIM: To evaluate the clinical efficacy, safety, and feasibility of sacral nerve root magnetic stimulation (SNRMS) vs sham in men with PPE. METHODS: From July 2023 to September 2024, we conducted a prospective, single-blind, randomized, sham-controlled trial. Fifty-three men meeting ISSM criteria for PPE (age 18-65, stable sexual relationship) were randomized 1:1. Active stimulation used a Magneuro60F coil positioned over S2-S4. Sham delivered identical coil placement and initial low-intensity pulse but no therapeutic output thereafter. Randomization used computer-generated permuted blocks with allocation concealment by sealed envelopes; patients were blinded, and outcome assessors/statisticians remained masked. Analyses used intention-to-treat principles; continuous outcomes reported as mean ± SD with 95% CI and Cohen's d; categorical outcomes compared with Fisher's exact test. OUTCOMES: Primary outcome was change in intravaginal ejaculatory latency time (IELT) measured by stopwatch at 6 months after treatment completion; treatment success defined as IELT ≥90 s at 6 months. Secondary outcomes included Premature Ejaculation Profile (PEP), sexual satisfaction (5-point Likert), International Index of Erectile Function (IIEF-5), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), SF-12 QoL, and adverse events. RESULTS: At 6 months, mean IELT increased from 37.4 ± 13.7 to 92.1 ± 46.4 s in the SNRMS group (mean change 54.7 s; 95% CI, 38.2-71.1; Cohen's d = 1.37). Treatment success (IELT ≥90 s) occurred in 33.3% (9/27) of SNRMS participants. PEP, sexual satisfaction, SAS, SDS, and SF-12 mental scores improved significantly more with SNRMS (all P < .01). Adverse events were mild and transient; no serious adverse events occurred. CLINICAL IMPLICATIONS: Sacral nerve root magnetic stimulation is a promising non-invasive therapy that can substantially prolong IELT and improve sexual and psychological outcomes in men with PPE, potentially offering a durable alternative to daily pharmacotherapy. STRENGTHS AND LIMITATIONS: Strengths include prospective randomized sham-control, blinded outcome assessment, and multi-domain outcomes with 6-month follow-up. Limitations include single-center design, modest sample size limiting subgroup analyses, lack of objective neurophysiological measures (electromyography [EMG]/functional MRI [fMRI]) to confirm mechanisms, and the need to confirm durability beyond 6 months. CONCLUSION: In this randomized sham-controlled study, SNRMS produced clinically and statistically significant improvements in IELT, ejaculatory control, sexual satisfaction, and psychological well-being in men with PPE.