At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Proteomic Pattern in Female Stress Urinary Incontinence: a Pilot Study
In Brief
An observational study evaluating collection of urine and blood sample for Female Stress Urinary Incontinence. Completed, enrolled 40 participants across 1 site.
Detailed Summary
Objective: The primary objective of the study is the comparison of protein concentrations between patients with stress urinary incontinence (SUI) and healthy controls. Aim: This pilot study aims to determine a possible altered protein profile in women suffering from SUI, compared to healthy women and therefore to discriminate a potential protein biomarker for SUI. Main outcome measure: mass spectrometric measuring of urinary proteomic secretome in diseased and healthy subjects (sequence coverage and number of identified proteins) Trial design: Prospective case- control study Setting: Department of Gynecology and Obstetrics of the Medical University of Vienna in co- operation with the Core Facilities Proteomics of the Medical University of Vienna Population: Twenty female patients with SUI and twenty healthy patients who attend the outpatient clinic of the Department of Obstetrics and Gynaecology, Medical University of Vienna (sample size calculation FDR 0.05, power of 80%, assumed proportion of true H0 0.95, assumed standardized effect size of 1) Methods: Examinations to be carried out: patient history, provocative stress test, ICIQ short form questionnaire, residual urine volume (ultrasound) and urine analysis (dipstick testing). A urine sample is obtained from the patient after spontaneous micturition, to which protease inhibitor will be added immediately. Two serum blood vials (each 9ml) are taken from a peripheral vein of the patient for routine laboratory and further research. Proteomics analysis will be performed using chromatographic separation (LC) with mass spectrometric detection (MS).