Vagus Nerve Stimulation in Premature Ejaculation

June 3, 2026 updated by: Alper Percin, Bahçeşehir University

Transcutaneous 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Premature ejaculation (PE) is one of the most common sexual dysfunctions in men, profoundly affecting the quality of life of both the patient and their partner. Many of the proposed definitions for PE are not based on scientific data and lack diagnostic criteria. The International Society for Sexual Medicine (ISSM) defines PE (lifelong and acquired) as characterized by the following criteria: Ejaculation that occurs almost always or always before or within 1 minute of vaginal penetration (lifelong PE) or a clinically significant decrease in ejaculation latency time, typically to 3 minutes or less (acquired PE); Inability to delay ejaculation in almost all or all vaginal penetrations (lifelong and acquired PE); Negative personal consequences such as distress, anxiety, disappointment, and/or avoidance of sexual intimacy (lifelong and acquired PE). Epidemiological studies based on patient-reported outcome measures have found the prevalence of PE complaints in the male population to be as high as 20-30%. A review of the literature reveals that approaches such as behavioral therapy, exercise programs, neuromuscular electrical stimulation, and yoga are used in the treatment of premature ejaculation, in addition to pharmacological treatment. However, no study has been found that examines the effectiveness of transcutaneous auricular vagal nerve stimulation on autonomic function and PE in men with PE. Therefore, this study was designed to examine the effects of taVNS on autonomic function and PE in men with PE. Participants will be randomly assigned to two groups (intra-auricular taVNS and intra-auricular sham-taVNS). The taVNS will be administered to each group three days per week, with 20-minute session durations, for 12 weeks. 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. For intra-auricular taVNS, bilateral ear sets with a 36-square-millimeter surface area to stimulate the tragus and concha will be used for intra-auricular taVNS. Sham group will also have the same specially designed electrodes placed intra-auricularly. The device will be turned on but set to 0 mA amplitude, so no electrical stimulation will occur. Heart rate variability, Premature Ejaculation Assessment Questionnaire, International Index of Erectile Function will be assessed before and after treatment.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Beşiktaş
      • Istanbul, Beşiktaş, Turkey (Türkiye), 34000
        • Bahcesehir University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stimulation Group
Transcutaneous auricular vagus nerve stimulation
Device: Transcutaneous Auricular Vagus Nerve Stimulation
Non-invasive electrical stimulation of the vagus nerve via the tragus and conchae
Placebo Comparator: Sham Stimulation Group
Sham Stimulation
Device: Transcutaneous Auricular Vagus Nerve Stimulation
Non-invasive electrical stimulation of the vagus nerve via the tragus and conchae

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: Baseline and at the end of the 12th week
Heart rate variability will be measured for 5 minutes over the chest using the Polar H10 device.
Baseline and at the end of the 12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahçeşehir University

Investigators

  • Study Director: Ramazan Cihad Yılmaz, Ph.D., Igdir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Actual)

April 30, 2026

Study Completion (Actual)

May 3, 2026

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVU00011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A decision on this matter will be made later.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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