Testing a new urine test for urethritis in healthy men
Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men
NA · Indiana University · NCT06951009
This study is testing a new urine test to see if it can quickly and accurately detect urethritis in healthy men aged 18 to 50 who don't have any symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Male |
| Sponsor | Indiana University (other) |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06951009 on ClinicalTrials.gov |
What this trial studies
This study aims to establish baseline results using the Sysmex UF-5000 flow cytometer to detect urethritis in healthy men aged 18 to 50 who show no symptoms. The research focuses on the potential of a non-invasive, point-of-care urine test that can provide results within 30 minutes, which could significantly improve the management of sexually transmitted infections (STIs) by identifying asymptomatic cases. By comparing this new method to traditional diagnostic approaches, the study seeks to enhance early diagnosis and treatment of urethritis, ultimately reducing the risk of STI transmission. Participants will provide urine samples for analysis over a two-week period.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy men aged 18 to 50 who do not exhibit any urethral symptoms.
Not a fit: Patients with a history of genital surgery, known urethral abnormalities, or recent STIs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more effective and accessible method for diagnosing urethritis, improving STI management and reducing transmission rates.
How similar studies have performed: While traditional methods for diagnosing urethritis are well-established, the use of urine flow cytometry as a point-of-care test is a novel approach that has not been widely tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men aged 18 to 50. * No urethral symptoms (discharge, dysuria) Exclusion Criteria: * History of genital surgery or known urethral abnormalities * Testing positive for gonorrhea and chlamydia * Diagnosis of a sexually transmitted infection within the last year. * Not available to collect a urine specimen in the morning 3x/week for 2 weeks
Where this trial is running
Indianapolis, Indiana
- Indiana University — Indianapolis, Indiana, United States (RECRUITING)
Study contacts
- Principal investigator: Stephen J Jordan, MD — Indiana University
- Study coordinator: Stephen J Jordan, MD
- Email: jordansj@iu.edu
- Phone: 317-274-8110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urethritis, Healthy Men Age 18-50 With no Urethral Symptoms