Combined pudendal nerve electroacupuncture and transcranial acupuncture stimulation for premature ejaculation: a randomized clinical study

Electroacupuntura del nervio pudendo combinada con estimulación acupuntural transcraneal para la eyaculación precoz: estudio clínico aleatorizado

Background: Premature ejaculation (PE) is a common and distressing condition with a multifactorial etiology and limited tolerable long-term treatment options. Current literature suggests that neuromodulatory approaches that simultaneously target peripheral reflex pathways and central regulatory mechanisms may provide additive therapeutic benefits. Methods: In this single-center, block-randomized clinical study, 120 men with PE were assigned to an observation group (n = 60) or a control group (n = 60). The observation group received pudendal nerve electroacupuncture (PNEA) combined with repetitive transcranial acupuncture stimulation (rTAS) twice weekly for 8 weeks, whereas the control group received PNEA alone on the same schedule. Fifty-three participants in the observation group and 55 in the control group completed follow-up. Outcomes, including intravaginal ejaculation latency time (IELT), Premature Ejaculation Diagnostic Tool (PEDT), Self-rating Anxiety Scale (SAS), and Self-rating Depression Scale (SDS) scores, were assessed at baseline and at week 8. Results: At week 8, the observation group exhibited a longer IELT and greater reductions in PEDT, SAS, and SDS scores than the control group (all p < 0.05). Overall response rates were 94.34% in the observation group and 83.64% in the control group (p = 0.12). No serious adverse events were observed, and reported adverse events were mild and transient. Conclusions: Compared with PNEA alone, combined PNEA+ rTAS provided greater improvements in ejaculatory latency and overall symptom burden over 8 weeks while maintaining good tolerability. These findings support integrated peripheral–central neuromodulation as a promising therapeutic option for PE and indicate that further confirmation in randomized, sham-controlled trials with longer follow-up is warranted. Clinical Trial Registration: The study was retrospectively registered with the International Traditional Medicine Clinical Trial Registry (ITMCTR) as: ITMCTR2025002555.

Resumen

Antecedentes: La eyaculación precoz (EP) es una afección frecuente y angustiante, de etiología multifactorial y con opciones limitadas de tratamiento a largo plazo que sean tolerables. La literatura actual indica que los enfoques neuromoduladores que actúan simultáneamente sobre las vías reflejas periféricas y los mecanismos reguladores centrales pueden aportar beneficios terapéuticos aditivos. Métodos: En este estudio clínico unicéntrico, aleatorizado por bloques, 120 varones con EP fueron asignados a un grupo de observación (n = 60) o a un grupo control (n = 60). El grupo de observación recibió electroacupuntura del nervio pudendo (PNEA) combinada con estimulación acupuntural transcraneal repetitiva (rTAS) dos veces por semana durante 8 semanas, mientras que el grupo control recibió únicamente PNEA con la misma pauta. Completaron el seguimiento 53 participantes del grupo de observación y 55 del grupo control. Los desenlaces, incluidos el tiempo de latencia eyaculatoria intravaginal (IELT), la herramienta diagnóstica de eyaculación precoz (PEDT) y las puntuaciones de la escala de autoevaluación de ansiedad (SAS) y la escala de autoevaluación de depresión (SDS), se evaluaron al inicio y en la semana 8. Resultados: En la semana 8, el grupo de observación presentó un IELT más prolongado y mayores reducciones en las puntuaciones de PEDT, SAS y SDS que el grupo control (todos p < 0.05). Las tasas de respuesta global fueron del 94.34% en el grupo de observación y del 83.64% en el grupo control (p = 0.12). No se observaron acontecimientos adversos graves, y los acontecimientos adversos notificados fueron leves y transitorios. Conclusiones: En comparación con PNEA sola, la combinación PNEA + rTAS proporcionó mayores mejoras en la latencia eyaculatoria y en la carga global de síntomas durante 8 semanas, manteniendo una buena tolerabilidad. Estos hallazgos respaldan la neuromodulación periférico-central integrada como una opción terapéutica prometedora para la EP e indican que se requiere confirmación adicional en ensayos aleatorizados, controlados con simulación (sham) y con un seguimiento más prolongado. Registro del Ensayo Clínico: El estudio se registró retrospectivamente en el International Traditional Medicine Clinical Trial Registry (ITMCTR) con el número: ITMCTR2025002555.

Premature ejaculation; Pudendal nerve electroacupuncture; Repetitive transcranial acupuncture stimulation

Palabras Clave

Eyaculación precoz; Electroacupuntura del nervio pudendo; Estimulación acupuntural transcraneal repetitive

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