Premature ejaculation
Conditions
Interventions
Primary premature ejaculation group:Oral ?-Aminobutyric Acid
Sponsors
Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: a. Male aged 18-60 years; b. Heterosexual, in a monogamous and stable sexual relationship with regular intercourse for at least 6 months; c. Symptoms of primary premature ejaculation (PPE): Reported intravaginal ejaculatory latency time (IELT) =1 minute since the first sexual experience, accompanied by poor ejaculatory control causing distress, frustration, embarrassment, and/or avoidance of sexual intimacy; d. Neurophysiological examination consistent with the diagnostic criteria for sympathetic hyperexcitability-associated premature ejaculation: - Penile sympathetic skin response (PSSR) latency 40.83 ms, - Dorsal nerve somatosensory evoked potentials (DNSEP) >39.03 ms; e. Voluntarily signed informed consent form, with full understanding and acceptance of the study duration, and willingness to comply with all requirements including scheduled treatments, follow-ups, and other study procedures; f. For patients with fertility intentions: Willingness to use highly effective contraception during the study and for 120 days after the last treatment.
Exclusion criteria
Exclusion criteria: a. Genitourinary infections:Presence of urinary tract infection symptoms (e.g., urinary irritation symptoms, prostatitis, hematospermia) or abnormal urinalysis findings (leukocyturia/hematuria); b. Organic abnormalities:** Congenital malformations of external genitalia (penis, scrotum, testis, epididymis or spermatic cord) or lumbar organic diseases; c. Systemic diseases:** Psychiatric disorders, endocrine diseases (hyper/hypothyroidism, gonadal dysfunction), neurological disorders, severe cardiovascular diseases (hypertension, hypotension), diabetes mellitus, epilepsy; Abnormal hepatic/renal function or coagulation parameters; d. Surgical/trauma history:** Previous penile dorsal neurectomy, erectile function-related surgeries, prostate/pelvic/lumbar surgeries; Major trauma history (severe straddle injuries, penile fracture, lumbar trauma); e. Medication/dietary factors: - Received sexual dysfunction treatments within 3 months prior to enrollment - Systemic/inhaled corticosteroid use or medications affecting GABA metabolism [4] - Significant dietary pattern changes during study period; f. Alcohol abuse or substance dependence; g. **Concomitant erectile dysfunction:** International Index of Erectile Function-5 (IIEF-5) score =21; h. **Claustrophobia or related conditions**, or history of adverse reactions during confined-space examinations (CT/MRI); i. **Occupations requiring high concentration:** Pilots, professional drivers, etc.; j. **Participation in other clinical trials within 1 month;** k. **Other conditions deemed ineligible by investigators.**
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intravaginal ejaculatory latency time; | — |
Countries
China
Contacts
Public ContactChunlu Xu
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Outcome results
None listed