ClinicalTrials.gg
CompletedNCT07300774Updated Jun 4, 2026

Vagus Nerve Stimulation in Premature Ejaculation

An interventional study of Transcutaneous Auricular Vagus Nerve Stimulation in Premature Ejaculation, sponsored by Bahçeşehir University. Completed at 1 site in Turkey (Türkiye). Open to male participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Bahçeşehir University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 14 studies in Premature Ejaculation with a site in Turkey — 3 open to participants now, 3 under way, none of them phase 3. Premature Ejaculation · Turkey.

Enrollment
3rd of 10
102 · median 67
Started
2025
with 2 others
No phase
8 of 14
2 open now
Registered
9th of 14
by date
Lead sponsor
2 of 14
Bahçeşehir University

Among the 14 studies in Premature Ejaculation with a site in Turkey, this one is the 3rd largest by enrollment of the 10 interventional ones, is one of 3 that started in 2025, is one of 8 with no phase, and was the 9th registered.

By phase

14 studies; the count open now beside each. This study's row is marked.

No phasethis study8 · 2 open
Observational4 · 1 open
Phase 42 · 0 open

By the year they started

First in 2016; this study’s year is marked. 3 started in 2025.

What they test

Size and results

Median enrollment 67 across the 10 interventional studies, 102 across the 4 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 14 studies in Premature Ejaculation with a site in Turkey, or all of them as a file.
02

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 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.

Read the 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.

03

Conditions studied

  • Premature Ejaculation

Browse trials for

Keywords

  • Vagus nerve stimulation
  • Heart Rate Variability
  • Premature Ejaculation
04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
102 participants (actual)

Study arms

  • Active comparator
    Stimulation Group

    Transcutaneous auricular vagus nerve stimulation

    Device: Transcutaneous Auricular Vagus Nerve Stimulation

  • Placebo comparator
    Sham Stimulation Group

    Sham Stimulation

    Device: Transcutaneous Auricular Vagus Nerve Stimulation

Interventions

  • DeviceTranscutaneous Auricular Vagus Nerve Stimulation

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

06

What researchers measure

Primary outcomes

  1. Heart Rate Variability

    Heart rate variability will be measured for 5 minutes over the chest using the Polar H10 device.

    Time frame: Baseline and at the end of the 12th week

07

Study locations

1 site
  • Bahcesehir University
    Istanbul, Beşiktaş 34000, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 27590186 ↗
  • 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. PubMed 31746051 ↗
  • 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. PubMed 25017593 ↗

Individual participant data

Plan to share: Undecided — A decision on this matter will be made later.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2025 to primary completion in Apr 2026, 4 months.

Of 25 interventional studies with no phase under Premature Ejaculation, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 39. This study's 4 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 4, 2025
First posted
Dec 24, 2025
StartActual
Dec 1, 2025
Primary completionActual
Apr 30, 2026
CompletionActual
May 3, 2026
Last update
Jun 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07300774
Responsible party
Alper Percin (Asst. Prof., Bahçeşehir University) — Principal investigator
First posted
Dec 24, 2025
Start date
Dec 1, 2025
Primary completion
Apr 30, 2026
Completion
May 3, 2026
Last update
Jun 4, 2026

Study contacts

Ramazan Cihad Yılmaz, Ph.D.
study director · Igdir University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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