Premature ejaculation
Conditions
Interventions
Treatment Group:Orally administered sertraline hydrochloride tablets (50 mg, once daily), Chinese herbal formula for premature ejaculation (200 mL, twice daily), electroacupuncture therapy for pudenda
Healthy Control Group:Non-intervention, only accept functional magnetic resonance imaging (fMRI), electroencephalogram (EEG) examination, collection of related samples, and multi-omics analysis.
Sponsors
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-50 years, male. 2.In generally good health and in a stable heterosexual relationship for over 6 months. 3.Diagnosis of premature ejaculation (Premature Ejaculation Diagnostic Tool (PEDT) score = 11). 4.Duration of symptoms of at least 3 months but less than 10 years. 5.Normal erectile function (International Index of Erectile Function (IIEF) score > 21). 6.Serum levels of total testosterone, prolactin, and thyroid-stimulating hormone (TSH) within normal ranges. 7.No phimosis or history of circumcision among all participants. 8.No use of medications for premature ejaculation within 2 weeks prior to grouping. If there is a history of medication use within this period, a 14-day washout period must be completed before enrollment. 9.Patients voluntarily agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.History of severe prostatitis symptoms, lower urinary tract symptoms, urinary tract infection, or substance abuse involving psychotropic medications. 2.History of severe psychiatric disorders, such as mood and anxiety disorders, schizophrenia, etc. 3.History of using medications known to affect ejaculation within the past 6 months. 4.International Index of Erectile Function (IIEF) score = 21. 5.Poorly controlled hypertension (systolic blood pressure = 160 mmHg and diastolic blood pressure = 100 mmHg despite treatment). 6.Poorly controlled diabetes mellitus (fasting plasma glucose (FPG) level > 7.0 mmol/L [126 mg/dL]). 7.Contraindications to magnetic resonance imaging (MRI). 8.Conditions preventing proper electrode placement (e.g., scalp trauma, infection). 9.Participation in any other clinical trial within the 3 months prior to this study, or any other condition deemed unsuitable for participation by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intravaginal Ejaculation Latency Time;Premature Ejaculation Diagnostic Tool score; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome score;fMRI;EEG;Metabolomic profiles and key metabolites; | — |
Countries
China
Contacts
Public ContactYue Duan
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed