Studies of Biomarkers in Female Lower Urinary Tract Symptoms

• Conditions: Disorder of the Lower Urinary Tract

• Registration Number: NCT01681784
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

To determine the sensitivity and specificity of urinary NGF, PGE2, IL-6, EGF or combinations in diagnosing different urodynamic diagnoses.

Detailed Description

Abstract

Background/Purpose:

Urodyamic study is an objective method to evaluate female patients with lower urinary tract symptoms (LUTS). However, this method includes place a urinary catheter, thus prevents it as a routine method to evaluate and follow up patients with LUTS. Therefore, it is necessary to find a simple and objective method to help in evaluating female patients with LUTS. Several kinds of biomarker had been reported in diagnosing patients with overactive bladder; however, the sensitivity remained poor. The aim of this study is to find a useful biomarker, biomarkers, or combinations, with the aid of urodynamic study, to objectively and precisely in evaluating the female patients with LUTS.

Patients and Methods:

We will perform a prospective study to recruit 300 female patients with LUTS at the outpatient clinic of Department of Obstetrics and Gynecology of National Taiwan University Hospital and Far Eastern Memorial Hospital.

All patients will be asked to complete OABSS, UDI-6 \& IIQ-7 questionnaires, voiding diary, 20-min pad test and urodynamic studies. Urinary nerve growth factor, prostaglandin E2, interleukin-6 and epidermal growth factor were also measured. Besides, we will also recruit 30 female patients without LUTS in our outpatient clinic, and they will be asked to complete the above questionnaire and examinations except pad test and urodynamic studies.

Possible Results:

With the comparison of the above parameters between non-LUTS and LUTS patients, we can answer the questions that (1) the mean values of urinary NGF, PGE2, IL-6, EGF in different urodynamic studies, (2) the sensitivity and specificity of urinary NGF, PGE2, IL-6, EGF or combinations in diagnosing different urodynamic diagnoses.

Study Timeline

• Study Start: 2009-01
• Status Verified: 2009-03
• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2012-09-07
• Last Update Submitted: 2012-09-07
• Study First Posted: 2012-09-10
• Last Update Posted: 2012-09-10
• Primary Completion: 2014-01
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

• Female patients with lower urinary tract symptoms

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Exclusion Criteria

• acute cystitis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan