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Studies of Biomarkers in Female Lower Urinary Tract Symptoms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01681784
First received: September 5, 2012
Last updated: September 7, 2012
Last verified: March 2009

September 5, 2012
September 7, 2012
January 2009
January 2014   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT01681784 on ClinicalTrials.gov Archive Site
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Studies of Biomarkers in Female Lower Urinary Tract Symptoms
Studies of Biomarkers in Different Urodynamic Diagnoses of Female Patients With Lower Urinary Tract Symptoms

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Patients' voided urine

Non-Probability Sample

Female patients with lower urinary tract symptoms and underwent urodynamic studies

Disorder of the Lower Urinary Tract
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female patients with lower urinary tract symptoms

Exclusion Criteria:

  • acute cystitis
Female
20 Years and older
Yes
Contact: Ho-Hsiung Lin, MD, PhD +88623123456 ext 71557 hhlin@ntuh.gov.tw
Taiwan
 
NCT01681784
200901031R
Yes
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Not Provided
National Taiwan University Hospital
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP