Examining brain activity during sexual behavior in men with premature ejaculation

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

This study tests how brain activity differs in men with premature ejaculation compared to those without it while they perform sexual tasks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Male
• Sponsor: Xijing Hospital (Academic / other)
• Locations: 2 sites (Xi'an, Shaanxi and 1 other locations)
• Trial ID: NCT06570135 on ClinicalTrials.gov

What this trial studies

This study investigates brain activity in men with primary premature ejaculation compared to those without the condition. Using near-infrared spectroscopy (NIRS), the research aims to detect and compare changes in brain activity during resting and simulated sexual tasks. The study includes men aged 18 to 45 who meet specific criteria for premature ejaculation and have stable heterosexual relationships. The goal is to better understand the neurological underpinnings of this condition.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 to 45 who meet the criteria for primary premature ejaculation and have a stable sexual relationship.

Not a fit: Patients who do not have premature ejaculation or those with a history of previous therapies for the condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and treatment options for men suffering from premature ejaculation.

How similar studies have performed: While studies on brain activity related to sexual behavior exist, this specific approach using NIRS in the context of premature ejaculation is relatively novel.

Eligibility criteria

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

Where this trial is running

Xi'an, Shaanxi and 1 other locations

• Air Force Military Medical University — Xi'an, Shaanxi, China (Recruiting)
• Air Force Military Medical University — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Study coordinator: Weijun Qin, M.D

Conditions Premature Ejaculation