Vagus Nerve Stimulation in Premature Ejaculation

Introduction: Premature ejaculation (PE), one of the most common sexual dysfunctions in men, negatively affects sexual function and quality of life. Transcutaneous auricular vagal nerve stimulation (taVNS) provides autonomic regulation non-invasively by balancing the sympathetic and parasympathetic systems. Objective: To investigate the effectiveness of taVNS on autonomic and sexual function in men with PE and to compare the effectiveness of different taVNS application methods. Materials and Methods: This prospective, randomized, sham-controlled, single-blind (evaluator) study will be conducted on 102 men with PE. Physical, sociodemographic, and clinical characteristics will be evaluated. Heart rate variability will be assessed using the Polar H10 device, premature ejaculation status using the Premature Ejaculation Assessment Questionnaire, and sexual function using the International Index of Erectile Function. Participants will be randomized into two groups (intra-auricular taVNS and sham-taVNS). taVNS treatment will be administered to each group three days per week, with 20-minute sessions, for 12 weeks. For in-ear taVNS, bilateral ear sets with a 36-square-millimeter surface area will be used to stimulate the tragus and concha will be used to stimulate the tragus and concha for intra-auricular taVNS, while adhesive electrode pads with a similar surface area of 36 square millimeters (3 mm × 12 mm) will be used for retroauricular taVNS. The taVNS protocol includes bilateral auricular stimulation for 20 minutes, a stimulation frequency of 25 hertz (Hz), a pulse width of 250 μs, suprathreshold current (0.13-50 mA), and a biphasic mode. Sham group will also have the same specially designed electrodes placed inside the ear. The device will be turned on but set to 0 mA amplitude, so no electrical stimulation will be delivered.

NCT Number	NCT07300774
Lead Sponsor	Bahçeşehir University
Conditions	Premature Ejaculation
Enrollment	102 participants
Start Date	2025-12-01
Primary Completion	2026-04-30 (estimated)
Study Completion	2026-05-03 (estimated)
Updated on ClinicalTrials.gov	2026-06-04