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

January 12, 2024 updated by: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210053
        • Recruiting
        • Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Premature ejaculation
Adult male with primary premature ejaculation. They will receive electroacupuncture at ST36 to treat premature ejaculation.
Device: Electroacupuncture 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline intravaginal ejaculatory latency time
Time Frame: Week 6, 10, 14, 18
IELT
Week 6, 10, 14, 18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Premature Ejaculation Diagnose Tool
Time Frame: Week 0, 6, 10, 14, 18
The premature ejaculation diagnostic tool (PEDT) is a brief diagnostic measure to assess premature ejaculation
Week 0, 6, 10, 14, 18
Premature Ejaculation Profile
Time Frame: Week 0, 6, 10, 14, 18
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.
Week 0, 6, 10, 14, 18
Chinese Index of Premature Ejaculation
Time Frame: Week 0, 6, 10, 14, 18
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.
Week 0, 6, 10, 14, 18
Penile Nerve Electrophysiology
Time Frame: Week 0, 6, 18
An electrophysiological technique used to examine the axonal composition and reflex activity of the penile nerve
Week 0, 6, 18
Clinical Global Impression of Change
Time Frame: Week 6, 18
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.
Week 6, 18
fMRI
Time Frame: Week 0, 6
Measure GABA levels in thalamic regions using GABA spectroscopy
Week 0, 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

  • Study Chair: Baibing Yang, Doctor, Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Actual)

December 15, 2023

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-LCYJ-PY-26

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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