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

Nanjing University

Status: Enrolling

Conditions: Premature Ejaculation

Treatments: Device: Electroacupuncture at ST36

Study type: Interventional

Funder types: Other

Identifiers

NCT06172855

2022-LCYJ-PY-26

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Premature ejaculation

Experimental group

Description:

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

Treatment:

Device: Electroacupuncture at ST36