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RecruitingNCT06172855Updated Jan 16, 2024

The Study on the Effectiveness and Safety of Electroacupuncture at ST36 in Treating Primary Premature Ejaculation

An interventional study of Electroacupuncture at ST36 in Premature Ejaculation, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Recruiting at 1 site in China. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-01-16.

Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
Male
01

Study summary

A pilot prospective single-arm cohort study on the Effectiveness and Safety of Electroacupuncture at ST36(Zusanli) in Treating Primary Premature Ejaculation

Read the detailed description

This is a pilot prospective single-arm cohort study to verify the Effectiveness and Safety of Electroacupuncture at ST36(Zusanli) in Treating Primary Premature Ejaculation, based on the result on animal study that daily electroacupuncture at ST36(Zusanli) for 30 days could delay the ejaculation of male SD rats.

02

Conditions studied

  • Premature Ejaculation

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Keywords

  • Premature Ejaculation
  • Electroacupuncture
  • ST36
03

In context

Premature Ejaculation

106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.

This study's planned enrollment of 35 is below the median of 84 across 89 interventional studies indexed under Premature Ejaculation.

Browse Premature Ejaculation studies →

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 250 studies on the registry; 147 are open to participants now.

Browse The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

  1. Age 18 to 60
  2. Heterosexual, with a single, stable partner for more than 6 months
  3. Symptoms of primary premature ejaculation: Complaints of IELT ≤ 1 min since the first sexual intercourse, and poor ability to control ejaculation leading to anxiety, annoyance, depression or/and avoidance of sexual life and other negative effects.

Exclusion criteria

Exclusion Criteria:

  1. Urinary system infection: Urinary tract infection symptoms (such as urinary tract irritation symptoms, prostatitis symptoms, blood semen, etc.) or urine routine shows abnormal white blood cells and red blood cells
  2. Abnormal androgen: sex hormone examination shows abnormal androgen (testosterone)
  3. Systemic diseases: ask about medical history of hypertension, diabetes, alcohol dependence, coronary heart disease and mental disorders
  4. Organic abnormalities: Abnormal development of external genitalia, bilateral testes, epididymis and spermatic cords with obvious abnormalities on palpation
  5. History of surgery and trauma: Dorsal nerve block of the penis, erectile function-related surgery, prostate surgery, pelvic surgery, etc.
  6. Influence of drugs: within one month before enrollment, have taken SSRI, tramadol and other drugs to treat diseases
  7. Allergy to dapoxetine and lidocaine
  8. History of drug, alcohol or substance abuse in the past 6 months
  9. Accompanied by erectile dysfunction: International Index of Erectile Function-5 (International Index of Erectile Function, IIEF-5) score ≤ 21 points
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Premature ejaculation

    Adult male with primary premature ejaculation. They will receive electroacupuncture at ST36 to treat premature ejaculation.

    Device: Electroacupuncture at ST36

Interventions

  • DeviceElectroacupuncture at ST36

    Electroacupuncture at ST36, which located at the anterior aspect of the lower leg, 3 cun below ST 35, one finger-breadth (middle finger) from the anterior crest of the tibia. Twice or 3 times per week, for 6 weeks.

06

What researchers measure

Primary outcomes

  1. Change from baseline intravaginal ejaculatory latency time

    IELT

    Time frame: Week 6, 10, 14, 18

Secondary outcomes

  1. Premature Ejaculation Diagnose Tool

    The premature ejaculation diagnostic tool (PEDT) is a brief diagnostic measure to assess premature ejaculation

    Time frame: Week 0, 6, 10, 14, 18

  2. Premature Ejaculation Profile

    Premature Ejaculation Profile (PEP) is a self-reported outcome instrument for evaluating domains of PE and its treatment and comprises of four single-item measures, a profile, and an index score.

    Time frame: Week 0, 6, 10, 14, 18

  3. Chinese Index of Premature Ejaculation

    The Chinese Index of Premature Ejaculation(CIPE) has 10 questions, focusing on libido, erectile function, ejaculatory latency, sexual satisfaction and difficulty in delaying ejaculation, self-confidence and depression. Each question was responded to on a 5 point Likert-type scale.

    Time frame: Week 0, 6, 10, 14, 18

  4. Penile Nerve Electrophysiology

    An electrophysiological technique used to examine the axonal composition and reflex activity of the penile nerve

    Time frame: Week 0, 6, 18

  5. Clinical Global Impression of Change

    Clinical Global Impressions (CGI) scale is a well-established research rating tool applicable to all psychiatric disorders that can easily be used by the practicing clinician to meet this need.

    Time frame: Week 6, 18

  6. fMRI

    Measure GABA levels in thalamic regions using GABA spectroscopy

    Time frame: Week 0, 6

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Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Serefoglu EC, McMahon CG, Waldinger MD, Althof SE, Shindel A, Adaikan G, Becher EF, Dean J, Giuliano F, Hellstrom WJ, Giraldi A, Glina S, Incrocci L, Jannini E, McCabe M, Parish S, Rowland D, Segraves RT, Sharlip I, Torres LO. An evidence-based unified definition of lifelong and acquired premature ejaculation: report of the second international society for sexual medicine ad hoc committee for the definition of premature ejaculation. Sex Med. 2014 Jun;2(2):41-59. doi: 10.1002/sm2.27. PubMed 25356301 ↗
  • Kimura K, Kitagawa Y, Tajima F. Effects of a Single Session of Acupuncture Treatment on Blood Pressure and Heart Rate Variability in Patients with Mild Hypertension. J Altern Complement Med. 2021 Apr;27(4):342-348. doi: 10.1089/acm.2020.0324. Epub 2021 Jan 28. PubMed 33512256 ↗
  • Xia JD, Chen J, Yang BB, Sun HJ, Zhu GQ, Dai YT, Yang J, Wang ZJ. Differences in sympathetic nervous system activity and NMDA receptor levels within the hypothalamic paraventricular nucleus in rats with differential ejaculatory behavior. Asian J Androl. 2018 Jul-Aug;20(4):355-359. doi: 10.4103/aja.aja_4_18. PubMed 29516873 ↗
  • Zhang QJ, Yang BB, Yang J, Wang YM, Dai YT, Song NH, Wang ZJ, Xia JD. Inhibitory Role of Gamma-Aminobutyric Receptors in Paraventricular Nucleus on Ejaculatory Responses in Rats. J Sex Med. 2020 Apr;17(4):614-622. doi: 10.1016/j.jsxm.2020.01.006. Epub 2020 Feb 7. PubMed 32037229 ↗
  • Liu S, Wang ZF, Su YS, Ray RS, Jing XH, Wang YQ, Ma Q. Somatotopic Organization and Intensity Dependence in Driving Distinct NPY-Expressing Sympathetic Pathways by Electroacupuncture. Neuron. 2020 Nov 11;108(3):436-450.e7. doi: 10.1016/j.neuron.2020.07.015. Epub 2020 Aug 12. PubMed 32791039 ↗
  • Sahin S, Bicer M, Yenice MG, Seker KG, Yavuzsan AH, Tugcu V. A Prospective Randomized Controlled Study to Compare Acupuncture and Dapoxetine for the Treatment of Premature Ejaculation. Urol Int. 2016;97(1):104-11. doi: 10.1159/000445253. Epub 2016 Apr 7. PubMed 27049323 ↗
  • Lu MJ, Yu Z, He Y, Yin Y, Xu B. Electroacupuncture at ST36 modulates gastric motility via vagovagal and sympathetic reflexes in rats. World J Gastroenterol. 2019 May 21;25(19):2315-2326. doi: 10.3748/wjg.v25.i19.2315. PubMed 31148903 ↗
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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

Started Jan 2024 (actual). Primary completion is estimated for Jun 2025, 17 months after the start.

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 planned 17 months is above that.

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

Registered
Jan 16, 2023
First posted
Dec 15, 2023
StartActual
Jan 1, 2024
Primary completionEst.
Jun 30, 2025
CompletionEst.
Dec 30, 2025
Last update
Jan 16, 2024
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 Jan 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06172855
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible party
Sponsor
First posted
Dec 15, 2023
Start date
Jan 1, 2024
Primary completion
Jun 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Jan 16, 2024

Study contacts

Baibing Yang, Doctor
Contact
njusupermario@163.com
+86 13914721216
Ning Wu, Doctor
Contact
wuningys@163.com
+86 13770803612
Baibing Yang, Doctor
study chair · Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School

Oversight

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

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