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

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.

Study Overview

• Status: Recruiting
• Conditions: Premature Ejaculation
• Intervention / Treatment: Diagnostic test: Detecting Brain Activity with Functional Near Infrared Spectroscopy

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weijun Qin, M.D; Phone Number: 13572501300; Email: qinwj@fmmu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 70032
      • Recruiting
      • Air Force Military Medical University
      • Contact: Weijun Qin, M.D; Phone Number: 13730192056 13730192056; Email: mengxl69@163.com
    • Xian, Shaanxi, China, 70032
      • Recruiting
      • Air Force Military Medical University
      • Contact: Weijun Qin, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: premature ejaculation group	Diagnostic test: Detecting Brain Activity with Functional Near Infrared Spectroscopy; Use a functional near-infrared spectroscopy to detect brain activity in the two groups of subjects during resting state and task state.
Experimental: Non-premature ejaculation group	Diagnostic test: Detecting Brain Activity with Functional Near Infrared Spectroscopy; Use a functional near-infrared spectroscopy to detect brain activity in the two groups of subjects during resting state and task state.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Results of near-infrared brain functional imaging	Data on changes in oxygenated hemoglobin concentration	1 hours

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2025
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Ejaculatory Dysfunction; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Premature Birth; Premature Ejaculation
• Other Study ID Numbers: KY20242242

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No