Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01681784 |
| Other study ID # |
200901031R |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
September 5, 2012 |
| Last updated |
September 7, 2012 |
| Start date |
January 2009 |
| Est. completion date |
January 2014 |
Study information
| Verified date |
March 2009 |
| Source |
National Taiwan University Hospital |
| Contact |
Ho-Hsiung Lin, MD, PhD |
| Phone |
+88623123456 |
| Email |
hhlin[@]ntuh.gov.tw |
| Is FDA regulated |
No |
| Health authority |
Taiwan: Department of Health |
| Study type |
Observational
|
Clinical Trial Summary
To determine the sensitivity and specificity of urinary NGF, PGE2, IL-6, EGF or combinations
in diagnosing different urodynamic diagnoses.
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.
