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Clinical Trials/NCT06172855
NCT06172855
Recruiting
Not Applicable

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

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 site in 1 country35 target enrollmentJanuary 1, 2024
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ConditionsPremature Ejaculation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Ejaculation
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Enrollment
35
Locations
1
Primary Endpoint
Change from baseline intravaginal ejaculatory latency time
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
December 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Change from baseline intravaginal ejaculatory latency time

Time Frame: Week 6, 10, 14, 18

IELT

Secondary Outcomes

  • Premature Ejaculation Diagnose Tool(Week 0, 6, 10, 14, 18)
  • Penile Nerve Electrophysiology(Week 0, 6, 18)
  • fMRI(Week 0, 6)
  • Premature Ejaculation Profile(Week 0, 6, 10, 14, 18)
  • Chinese Index of Premature Ejaculation(Week 0, 6, 10, 14, 18)
  • Clinical Global Impression of Change(Week 6, 18)

Study Sites (1)

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