Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial

Phase

N/A

Condition

Premature Ejaculation

Treatment

Detecting Brain Activity with Functional Near Infrared Spectroscopy

Clinical Study ID

NCT06570135

KY20242242

Ages 18-45
Male
Accepts Healthy Volunteers

Study 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 activity in resting and task states (Simulated Sex) between the two groups of patients.

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) definitioncriteria for PPE；
patients had a stable, heterosexual relationship with a single sexually activefemale partner for at least 6 months and with at least two sexual intercourses aweek 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 versionof Premature Ejaculation Diagnostic Tool (PEDT);
patients had no history of any previous therapies for PE or had recently stopped thetherapies 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 ifmore than one volunteer was eligible at the same time, the one with the closest agewas 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 activefemale partner for at least 6 months and with at least two sexual intercourses aweek and kept stable during the study period;
patients had fully informed consent, signed informed consent form；

Exclusion

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 onthe 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 tractinfection;
patients with head injuries that prevent them from completing near-infrared lightbrain function imaging
Patients with severe schizophrenia, anxiety, depression or other neurologicalsymptoms or poor compliance

Study Design