Vagus Nerve Stimulation in Premature Ejaculation

NCT ID: NCT07300774

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-02
• Study Completion Date: 2026-06-01

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.

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 four groups (intra-auricular taVNS, retro-auricular taVNS, intra-auricular sham-taVNS, and retro-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, and adhesive electrode pads with a similar surface area of 36 square millimeters (3 mm × 12 mm) will be used for retroauricular taVNS. Sham groups will also have the same specially designed electrodes placed intra-auricularly and retroauricularly. 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.

Conditions

Premature Ejaculation

Keywords

Vagus nerve stimulation; Heart Rate Variability; Premature Ejaculation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Stimulation Group

Transcutaneous auricular vagus nerve stimulation

Group Type: ACTIVE_COMPARATOR

Transcutaneous Auricular Vagus Nerve Stimulation

Intervention Type: DEVICE

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

Sham Stimulation Group

Sham Stimulation

Group Type: PLACEBO_COMPARATOR

Transcutaneous Auricular Vagus Nerve Stimulation

Intervention Type: DEVICE

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

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bahçeşehir University

OTHER

Sponsor Role: lead

Responsible Party

Alper Percin

Asst. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ramazan Cihad Yılmaz, Ph.D.

Role: STUDY_DIRECTOR

Igdir University

Locations

Bahcesehir University

Istanbul, Beşiktaş, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Alper Percin, Ph.D.

Role: CONTACT

Phone: +905452557585

Email: alperpercin@avrasya.edu.tr

References

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.

Reference Type: BACKGROUND

PMID: 25017593 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31746051 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27590186 (View on PubMed)

Other Identifiers

AVU00011

Identifier Type: -

Identifier Source: org_study_id