Premature Ejaculation
Conditions
Keywords
Premature Ejaculation, Electroacupuncture, ST36
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.
Interventions
DEVICEElectroacupuncture 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.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline intravaginal ejaculatory latency time | Week 6, 10, 14, 18 | IELT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| fMRI | Week 0, 6 | Measure GABA levels in thalamic regions using GABA spectroscopy |
| Penile Nerve Electrophysiology | Week 0, 6, 18 | An electrophysiological technique used to examine the axonal composition and reflex activity of the penile nerve |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactBaibing Yang, Doctor
Backup ContactNing Wu, Doctor
Outcome results
None listed