COMPLETED

Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Acute urethritis (inflammation of the male urethra) affects millions of men in the United States each year. Effective management of STIs is complicated by asymptomatic infections, as men often delay seeking care until symptoms become severe. Yet, even men without symptoms can show measurable evidence of urethritis. Therefore, a cheap, simple, and non-invasive point-of-care (POC) test, providing results within 30 minutes, could significantly enhance STI management by facilitating early diagnosis and treatment. A new diagnostic method, urine flow cytometry, has shown potential in hospital settings for accurately detecting inflammation by counting white blood cells (infection-fighting cells) in urine samples. The Sysmex UF-5000 flow cytometer, a state-of-the-art device, may offer a non-invasive, cost-effective, and accurate method to diagnose urethritis compared to traditional Gram stains and urinalysis, potentially extending its use beyond specialized clinics. This study aims to determine the efficacy and precision of the Sysmex UF-5000 analyzer in diagnosing urethritis using first-catch urine samples. Additionally, the study seeks to evaluate whether urine collected using the 10 mL Colli-Pee device provides greater accuracy and precision compared to the standard urine cup (30-60 mL) when used with urine flow cytometry and LE urinalysis.

Official Title

Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men

Quick Facts

Study Start:2025-04-09
Study Completion:2025-05-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06951009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men aged 18 to 50.
  2. * No urethral symptoms (discharge, dysuria)
  1. * History of genital surgery or known urethral abnormalities
  2. * Testing positive for gonorrhea and chlamydia
  3. * Diagnosis of a sexually transmitted infection within the last year.
  4. * Not available to collect a urine specimen in the morning 3x/week for 2 weeks

Contacts and Locations

Principal Investigator

Stephen J Jordan, MD
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

Indiana University
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Stephen J Jordan, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-09
Study Completion Date2025-05-07

Study Record Updates

Study Start Date2025-04-09
Study Completion Date2025-05-07

Terms related to this study

Additional Relevant MeSH Terms

  • Urethritis
  • Healthy Men Age 18-50 With no Urethral Symptoms