Studies of Biomarkers in Female Lower Urinary Tract Symptoms

Studies of Biomarkers in Different Urodynamic Diagnoses of Female Patients With Lower Urinary Tract Symptoms

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01681784

Enrollment

1000

Registered

2012-09-10

Start date

2009-01-31

Completion date

2014-01-31

Last updated

2012-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of the Lower Urinary Tract

Keywords

lower urinary tract symptoms, biomarkers, urodynamic studies

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Female patients with lower urinary tract symptoms

Exclusion criteria

* acute cystitis

Countries

Taiwan

Contacts

Primary ContactHo-Hsiung Lin, MD, PhD

hhlin@ntuh.gov.tw+88623123456

Outcome results