Status:
RECRUITING
Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial
Lead Sponsor:
Xijing Hospital
Conditions:
Premature Ejaculation
Eligibility:
MALE
18-45 years
Phase:
NA
Brief Summary
This is a controlled study of patients with and without primary premature ejaculation. It is based on near-infrared spectroscopy (NIRS) functional brain imaging to detect and compare changes in brain ...
Eligibility Criteria
Inclusion
- Inclusion Criteria (primary premature ejaculation subjects):
- patients' age varied from 18 to 45 years；
- patients met the 2014 International Society for Sexual Medicine (ISSM) definition criteria for PPE；
- patients had a stable, heterosexual relationship with a single sexually active female partner for at least 6 months and with at least two sexual intercourses a week and kept stable during the study period;
- Patients with premature ejaculation lasting longer than 6 months；
- patients were identified if their scores were higher than 9 on the Chinese version of Premature Ejaculation Diagnostic Tool (PEDT);
- patients had no history of any previous therapies for PE or had recently stopped the therapies for at least 3 months
- patients had fully informed consent, signed informed consent form
- Inclusion Criteria (Non-premature ejaculation subjects):
- Men between the ages of 18-45 years were included according to an age difference of \<3 years between each patient and the primary premature ejaculation group, and if more than one volunteer was eligible at the same time, the one with the closest age was selected；
- Patient does not meet the 2014 International Society for Sexual Medicine (ISSM) criteria for defining premature ejaculation；
- patients had a stable, heterosexual relationship with a single sexually active female partner for at least 6 months and with at least two sexual intercourses a week and kept stable during the study period;
- patients had fully informed consent, signed informed consent form；
- Exclusion Criteria:
- patients were diagnosed with secondary PE, variable PE, and subjective PE;
- patients were using medications for endocrinological, metabolic, chronic systemic, or psychiatric diseases;
- patients were abusing alcohol or illegal drugs；
- patients were diagnosed with erectile dysfunction (ED) if their scores were \<21 on the abridged five-item International Index of Erectile Function (IIEF-5)
- patients were diagnosed with sexual hormone abnormalities, hyperthyroidism, hypothyroidism, Peyronie's disease, prostatitis, urethritis, or urinary tract infection;
- patients with head injuries that prevent them from completing near-infrared light brain function imaging
- Patients with severe schizophrenia, anxiety, depression or other neurological symptoms or poor compliance
Exclusion
Key Trial Info
Start Date :
April 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06570135
Start Date
April 8 2025
End Date
December 30 2025
Last Update
April 17 2025
Active Locations (2)
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1
Air Force Military Medical University
Xi'an, Shaanxi, China, 70032
2
Air Force Military Medical University
Xi'an, Shaanxi, China, 70032