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

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

Detailed Description
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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.

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

Conditions
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Premature Ejaculation

Intervention / Treatment
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* Device: Electroacupuncture at ST36


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Premature Ejaculation Diagnose Tool | The premature ejaculation diagnostic tool (PEDT) is a brief diagnostic measure to assess premature ejaculation | Week 0, 6, 10, 14, 18 | 
| 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. | Week 0, 6, 10, 14, 18 | 
| 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. | Week 0, 6, 10, 14, 18 | 
| Penile Nerve Electrophysiology | 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 | 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 | Measure GABA levels in thalamic regions using GABA spectroscopy | Week 0, 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Ejaculation, Electroacupuncture, ST36