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Studies of Biomarkers in Female Lower Urinary Tract Symptoms

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01681784
First Posted: September 10, 2012
Last Update Posted: September 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose
To determine the sensitivity and specificity of urinary NGF, PGE2, IL-6, EGF or combinations in diagnosing different urodynamic diagnoses.

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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   Samples With DNA
Patients' voided urine

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)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Female patients with lower urinary tract symptoms and underwent urodynamic studies
Criteria

Inclusion Criteria:

  • Female patients with lower urinary tract symptoms

Exclusion Criteria:

  • acute cystitis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681784


Contacts
Contact: Ho-Hsiung Lin, MD, PhD +88623123456 ext 71557 hhlin@ntuh.gov.tw

Locations
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         
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital, Professor Ho-Hsiung Lin
ClinicalTrials.gov Identifier: NCT01681784     History of Changes
Other Study ID Numbers: 200901031R
First Submitted: September 5, 2012
First Posted: September 10, 2012
Last Update Posted: September 10, 2012
Last Verified: March 2009

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


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