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Studies of Biomarkers in Female Lower Urinary Tract Symptoms
Recruitment status was: Recruiting
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Purpose
| Condition |
|---|
| Disorder of the Lower Urinary Tract |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Studies of Biomarkers in Different Urodynamic Diagnoses of Female Patients With Lower Urinary Tract Symptoms |
| Estimated Enrollment: | 1000 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Female patients with lower urinary tract symptoms
Exclusion Criteria:
- acute cystitis
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01681784
| Contact: Ho-Hsiung Lin, MD, PhD | +88623123456 ext 71557 | hhlin@ntuh.gov.tw |
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan, 100 | |
| Contact: Ho-Hsiung Lin, MD, PhD +886-23123456 ext 71557 hhlin@ntuh.gov.tw | |
| Principal Investigator: Ho-Hsiung Lin, MD, PhD | |
More Information
| Responsible Party: | National Taiwan University Hospital, Professor Ho-Hsiung Lin |
| ClinicalTrials.gov Identifier: | NCT01681784 History of Changes |
| Other Study ID Numbers: |
200901031R |
| Study First Received: | September 5, 2012 |
| Last Updated: | September 7, 2012 |
Keywords provided by National Taiwan University Hospital:
|
lower urinary tract symptoms biomarkers urodynamic studies |
Additional relevant MeSH terms:
|
Lower Urinary Tract Symptoms Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on July 21, 2017