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

NCT06570135 | Recruiting

• 1 other identifier: KY20242242
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Conditions

Premature Ejaculation

Outcome Measures

Primary Outcomes (1)

• Results of near-infrared brain functional imaging

  Data on changes in oxygenated hemoglobin concentration

  1 hours

Study Arms (2)

premature ejaculation group

EXPERIMENTAL

Diagnostic Test: Detecting Brain Activity with Functional Near Infrared Spectroscopy

Non-premature ejaculation group

EXPERIMENTAL

Diagnostic Test: Detecting Brain Activity with Functional Near Infrared Spectroscopy

Interventions

Detecting Brain Activity with Functional Near Infrared Spectroscopy DIAGNOSTIC_TEST

Use a functional near-infrared spectroscopy to detect brain activity in the two groups of subjects during resting state and task state.

Non-premature ejaculation group; premature ejaculation group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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；

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (2)

Air Force Military Medical University

Xi'an, Shaanxi, 70032, China

RECRUITING

Air Force Military Medical University

Xi'an, Shaanxi, 70032, China

RECRUITING

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Weijun Qin, M.D

CONTACT

13572501300; qinwj@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 26, 2024
• Study Start: April 8, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 17, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)