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Proteomic Pattern in Female Stress Urinary Incontinence: a Pilot Study

NCT02023502 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2024-03-15

No results posted yet for this study

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).

Conditions

  • Female Stress Urinary Incontinence

Interventions

OTHER

collection of urine and blood sample

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Heinz Kölbl, Univ.-Prof.Dr.Dr.h.c. · Medical University of Vienna, Department of Obstetrics and Gynaecology

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-04-30
Completion
2015-09-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02023502 on ClinicalTrials.gov