CompletedNot Applicable

Vagus Nerve Stimulation in Premature Ejaculation

Turkey (Türkiye)102 participantsStarted 2025-12-01

Plain-language summary

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.

Who can participate

Age range

30 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Having a diagnosis of premature ejaculation according to the International Society for Sexual Medicine (ISSM), * Having the same, non-pregnant, sexually active partner for at least 6 months, * Being in a stable, heterosexual relationship, * Suffering from PE and seeking medical treatment. Exclusion Criteria: * Having acquired PE, * History of vagotomy, * Having diabetes, hypertension, cardiovascular disease, * Abnormal neurological examination findings, * Use of drugs that impair heart rate variability (agents, a-receptor agonists or antagonists, tricyclic or serotonergic antidepressants, antihypertensive drugs) * History of pelvic surgery, * Tobacco or alcohol use, * Any organic cause of PE (as assessed by prostatic secretion analysis, thyroid-stimulating hormone); * Having a psychiatric disorder, * Having skin irritation/lesion at the application site, * International Index of Erectile Function score below 26

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Heart Rate Variability

Timeframe: Baseline and at the end of the 12th week

Trial details

NCT IDNCT07300774

SponsorBahçeşehir University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-30

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