Psychometric properties of a self-assessment questionnaire concerning symptoms and impairment in urinary tract infections: the UTI-SIQ-8.
Ildikó Gágyor, Katrin Rentzsch, Stephanie Strube-Plaschke...
https://pubmed.ncbi.nlm.nih.gov/33589460Actively Recruiting
Led by Wuerzburg University Hospital · Updated on 2025-02-17
200
Participants Needed
2
Research Sites
N/A
Total Duration
W
Wuerzburg University Hospital
Lead Sponsor
J
Jena University Hospital
Collaborating Sponsor
This research focuses on adult women who visit their general practitioner with symptoms suggesting a bladder infection, such as burning during urination, lower abdominal pain, and frequent or urgent urination. The study aims to evaluate the accuracy of a new point-of-care urine test system called PA-100-AST from Sysmex, comparing it to the traditional laboratory urine culture test. This observational study is conducted in general practice settings to see how well the PA-100-AST performs for diagnosing uncomplicated urinary tract infections in women. The PA-100-AST system rapidly detects bacteria in urine and reports antibiotic susceptibility for common antibiotics used to treat urinary tract infections. It identifies bacterial groups but does not specify exact bacterial species. Urine samples are tested immediately after collection with the PA-100-AST, and additional samples are sent to labs for standard culture tests. The study involves adult women suspected of uncomplicated UTIs visiting several general practices, with all testing done under routine conditions. Participants provide urine samples and complete a questionnaire at their initial visit. Researchers collect clinical data, dipstick test results, and antibiotic susceptibility information. The main outcome measures include the test's sensitivity, specificity, predictive values, and likelihood ratios compared to the lab culture. The study also explores agreement between the PA-100-AST and lab susceptibility results. Participation involves routine consultations, and results help assess the new test's usefulness in general practice.
CONDITIONS
Rapid Point-of-care Bacteriuria and Microbial Susceptibility for Women With Suspected Uncomplicated Urinary Tract Infections: Diagnostic Accuracy in General Practice.
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during routine consultation
Duration - Same day as enrollment
Participants provide a fresh urine sample for rapid point-of-care testing and laboratory-based urine culture to evaluate bacteriuria and antibiotic susceptibility.
1 visit (in-person) for urine sample collection and testing
Duration - Up to 1 day
Participants are observed through data collection on clinical symptoms and management decisions during routine care.
Data collected during initial visit; no additional visits required
Total: 2 locations
1
University Hospital Wurzburg, Department of General Practice
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
2
University Hospital Jena
Jena, Thuringia, Germany, 07743
Actively Recruiting
P
Peter K. Kurotschka, MD
K
Kathrin Lasher, Nurse
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Ildikó Gágyor, Katrin Rentzsch, Stephanie Strube-Plaschke...
https://pubmed.ncbi.nlm.nih.gov/33589460Carles Alonso-Tarrés, Carla Benjumea Moreno, Ferran Navarro...
https://pubmed.ncbi.nlm.nih.gov/38825624