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Vagus Nerve Stimulation in Premature Ejaculation

NCT07300774 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-12-24

No results posted yet for this study

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

Interventions

DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation

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

Sponsors & Collaborators

  • Bahçeşehir University

    lead OTHER

Principal Investigators

  • Ramazan Cihad Yılmaz, Ph.D. · Igdir University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-02
Primary Completion
2026-05-30
Completion
2026-06-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07300774 on ClinicalTrials.gov