Vagus Nerve Stimulation in Premature Ejaculation

NCT07300774 | Not Yet Recruiting DMC

• 1 other identifier: AVU00011
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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 H7 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 groups 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.

Conditions

Premature Ejaculation

Keywords

Vagus nerve stimulation; Heart Rate Variability; Premature Ejaculation

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability

  Heart rate variability will be measured for 5 minutes over the chest using the Polar H7 device.

  Baseline and at the end of the 12th week

Study Arms (2)

Stimulation Group

ACTIVE COMPARATOR

Transcutaneous auricular vagus nerve stimulation

Device: Transcutaneous Auricular Vagus Nerve Stimulation

Sham Stimulation Group

PLACEBO COMPARATOR

Sham Stimulation

Device: Transcutaneous Auricular Vagus Nerve Stimulation

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation DEVICE

Non-invasive electrical stimulation of the vagus nerve via the tragus and conchae

Sham Stimulation Group; Stimulation Group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Gender Eligibility Details: Men who experience premature ejaculation will be included in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Bahcesehir University

Istanbul, Beşiktaş, 34000, Turkey (Türkiye)

Location

Related Publications (3)

• Ventus D, Jern P. Lifestyle Factors and Premature Ejaculation: Are Physical Exercise, Alcohol Consumption, and Body Mass Index Associated With Premature Ejaculation and Comorbid Erectile Problems? J Sex Med. 2016 Oct;13(10):1482-7. doi: 10.1016/j.jsxm.2016.08.007. Epub 2016 Aug 31.

  PMID: 27590186 BACKGROUND

• Jiang M, Yan G, Deng H, Liang H, Lin Y, Zhang X. The efficacy of regular penis-root masturbation, versus Kegel exercise in the treatment of primary premature ejaculation: A quasi-randomised controlled trial. Andrologia. 2020 Feb;52(1):e13473. doi: 10.1111/and.13473. Epub 2019 Nov 20.

  PMID: 31746051 BACKGROUND

• La Pera G. Awareness and timing of pelvic floor muscle contraction, pelvic exercises and rehabilitation of pelvic floor in lifelong premature ejaculation: 5 years experience. Arch Ital Urol Androl. 2014 Jun 30;86(2):123-5. doi: 10.4081/aiua.2014.2.123.

  PMID: 25017593 BACKGROUND

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Ramazan Cihad Yılmaz, Ph.D.

  Igdir University

  STUDY DIRECTOR

Central Study Contacts

Alper Percin, Ph.D.

CONTACT

+905452557585; alperpercin@avrasya.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this study, assessor blinding will be performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: A comparison between transcutaneous auricular vagus nerve stimulation and sham stimulation will be performed.

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 24, 2025
• Study Start: January 2, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

TU (1)