NCT06172855

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2023

Completed
11 months until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

January 16, 2024

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

January 16, 2023

Last Update Submit

January 12, 2024

Conditions

Premature Ejaculation

Keywords

Premature EjaculationElectroacupunctureST36

Outcome Measures

Primary Outcomes (1)

  • Change from baseline intravaginal ejaculatory latency time

    IELT

    Week 6, 10, 14, 18

Secondary Outcomes (6)

  • Premature Ejaculation Diagnose Tool

    Week 0, 6, 10, 14, 18

  • Premature Ejaculation Profile

    Week 0, 6, 10, 14, 18

  • Chinese Index of Premature Ejaculation

    Week 0, 6, 10, 14, 18

  • Penile Nerve Electrophysiology

    Week 0, 6, 18

  • Clinical Global Impression of Change

    Week 6, 18

  • +1 more secondary outcomes

Study Arms (1)

Premature ejaculation

EXPERIMENTAL

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

Device: Electroacupuncture at ST36

Interventions

Electroacupuncture at ST36DEVICE

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.

Premature ejaculation

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 60
  • Heterosexual, with a single, stable partner for more than 6 months
  • 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.

You may not qualify if:

  • 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
  • Abnormal androgen: sex hormone examination shows abnormal androgen (testosterone)
  • Systemic diseases: ask about medical history of hypertension, diabetes, alcohol dependence, coronary heart disease and mental disorders
  • Organic abnormalities: Abnormal development of external genitalia, bilateral testes, epididymis and spermatic cords with obvious abnormalities on palpation
  • History of surgery and trauma: Dorsal nerve block of the penis, erectile function-related surgery, prostate surgery, pelvic surgery, etc.
  • Influence of drugs: within one month before enrollment, have taken SSRI, tramadol and other drugs to treat diseases
  • Allergy to dapoxetine and lidocaine
  • History of drug, alcohol or substance abuse in the past 6 months
  • Accompanied by erectile dysfunction: International Index of Erectile Function-5 (International Index of Erectile Function, IIEF-5) score ≤ 21 points

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School

Nanjing, Jiangsu, 210053, China

RECRUITING

Related Publications (7)

  • 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.

    PMID: 25356301BACKGROUND

  • 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.

    PMID: 33512256BACKGROUND

  • 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.

    PMID: 29516873RESULT

  • 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.

    PMID: 32037229RESULT

  • 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.

    PMID: 32791039RESULT

  • 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.

    PMID: 27049323RESULT

  • 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.

    PMID: 31148903RESULT

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory DysfunctionGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Baibing Yang, Doctor

    Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School

    STUDY CHAIR

Central Study Contacts

Baibing Yang, Doctor

CONTACT

+86 13914721216njusupermario@163.com

Ning Wu, Doctor

CONTACT

+86 13770803612wuningys@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2023

First Posted

December 15, 2023

Study Start

January 1, 2024

Primary Completion

June 30, 2025

Study Completion

December 30, 2025

Last Updated

January 16, 2024

Record last verified: 2023-12

Locations

CN(1)