Clinical Evaluation of Self-collected Urine Samples for the Detection of Human Papillomavirus in Males

What this Trial Is About

Human papillomavirus (HPV) infection is a common viral infection of the genital tract mainly spread through sexual contact, with an estimated 85% to 90% lifetime infection risk among sexually active individuals. While much research has focused on HPV in women, studies on male HPV infections are limited. Many men carry HPV without symptoms, which complicates prevention and control efforts. This study aims to develop and evaluate a reliable method for detecting HPV in men using self-collected urine samples, which could offer a less invasive and more convenient alternative to traditional penile swab tests. The study consists of two parts. The first part compares HPV detection results from self-collected urine samples with those from physician-collected penile samples in male patients with genital warts, penile intraepithelial neoplasia (PIN), and penile cancer. The second part investigates HPV consistency between urine samples from male patients and their female partners by comparing male urine and penile samples with cervical swabs from female partners. Participants provide self-collected urine samples followed by physician-collected samples for comparison. Participants will provide urine and swab samples, and data will be collected to compare HPV detection accuracy between self-collected urine and physician-collected genital samples, as well as between couples. The main outcome is to evaluate the test results of the new HPV detection method on urine samples compared to standard genital sample tests within a 12-week period. Secondary outcomes include assessing the consistency of HPV presence in couples within 8 weeks. This research may provide new strategies for male-specific HPV detection using home-based self-testing methods.

Clinical Performance of Urine HPV Testing in Males