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

Not Applicable

Recruiting

• Conditions: Premature Ejaculation
• Interventions: Device: Electroacupuncture at ST36

• Registration Number: NCT06172855
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Study Timeline

• Study First Submitted: 2023-01-16
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-15
• Study Start: 2024-01-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-16
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Premature ejaculation	Electroacupuncture at ST36	Adult male with primary premature ejaculation. They will receive electroacupuncture at ST36 to treat premature ejaculation.

Primary Outcome Measures

Name	Time	Method
Change from baseline intravaginal ejaculatory latency time	Week 6, 10, 14, 18	IELT

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China