<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01681784</url>
  </required_header>
  <id_info>
    <org_study_id>200901031R</org_study_id>
    <nct_id>NCT01681784</nct_id>
  </id_info>
  <brief_title>Studies of Biomarkers in Female Lower Urinary Tract Symptoms</brief_title>
  <official_title>Studies of Biomarkers in Different Urodynamic Diagnoses of Female Patients With Lower Urinary Tract Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the sensitivity and specificity of urinary NGF, PGE2, IL-6, EGF or combinations&#xD;
      in diagnosing different urodynamic diagnoses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Abstract&#xD;
&#xD;
      Background/Purpose:&#xD;
&#xD;
      Urodyamic study is an objective method to evaluate female patients with lower urinary tract&#xD;
      symptoms (LUTS). However, this method includes place a urinary catheter, thus prevents it as&#xD;
      a routine method to evaluate and follow up patients with LUTS. Therefore, it is necessary to&#xD;
      find a simple and objective method to help in evaluating female patients with LUTS. Several&#xD;
      kinds of biomarker had been reported in diagnosing patients with overactive bladder; however,&#xD;
      the sensitivity remained poor. The aim of this study is to find a useful biomarker,&#xD;
      biomarkers, or combinations, with the aid of urodynamic study, to objectively and precisely&#xD;
      in evaluating the female patients with LUTS.&#xD;
&#xD;
      Patients and Methods:&#xD;
&#xD;
      We will perform a prospective study to recruit 300 female patients with LUTS at the&#xD;
      outpatient clinic of Department of Obstetrics and Gynecology of National Taiwan University&#xD;
      Hospital and Far Eastern Memorial Hospital.&#xD;
&#xD;
      All patients will be asked to complete OABSS, UDI-6 &amp; IIQ-7 questionnaires, voiding diary,&#xD;
      20-min pad test and urodynamic studies. Urinary nerve growth factor, prostaglandin E2,&#xD;
      interleukin-6 and epidermal growth factor were also measured. Besides, we will also recruit&#xD;
      30 female patients without LUTS in our outpatient clinic, and they will be asked to complete&#xD;
      the above questionnaire and examinations except pad test and urodynamic studies.&#xD;
&#xD;
      Possible Results:&#xD;
&#xD;
      With the comparison of the above parameters between non-LUTS and LUTS patients, we can answer&#xD;
      the questions that (1) the mean values of urinary NGF, PGE2, IL-6, EGF in different&#xD;
      urodynamic studies, (2) the sensitivity and specificity of urinary NGF, PGE2, IL-6, EGF or&#xD;
      combinations in diagnosing different urodynamic diagnoses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2009</start_date>
  <completion_date type="Anticipated">January 2014</completion_date>
  <primary_completion_date type="Anticipated">January 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Disorder of the Lower Urinary Tract</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Patients' voided urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Female patients with lower urinary tract symptoms and underwent urodynamic studies&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients with lower urinary tract symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute cystitis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ho-Hsiung Lin, MD, PhD</last_name>
    <phone>+88623123456</phone>
    <phone_ext>71557</phone_ext>
    <email>hhlin@ntuh.gov.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ho-Hsiung Lin, MD, PhD</last_name>
      <phone>+886-23123456</phone>
      <phone_ext>71557</phone_ext>
      <email>hhlin@ntuh.gov.tw</email>
    </contact>
    <investigator>
      <last_name>Ho-Hsiung Lin, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2009</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>September 7, 2012</last_update_submitted>
  <last_update_submitted_qc>September 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Taiwan University Hospital</investigator_affiliation>
    <investigator_full_name>National Taiwan University Hospital</investigator_full_name>
    <investigator_title>Professor Ho-Hsiung Lin</investigator_title>
  </responsible_party>
  <keyword>lower urinary tract symptoms</keyword>
  <keyword>biomarkers</keyword>
  <keyword>urodynamic studies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lower Urinary Tract Symptoms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01681784
org study id: 200901031R
nct id: NCT01681784
lead sponsor: 
has dmc: Yes
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 model: Cohort
time perspective: Prospective
Patients' voided urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ho-Hsiung Lin, MD, PhD
phone: +88623123456
phone ext: 71557
email: hhlin@ntuh.gov.tw
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Taiwan University Hospital
investigator full name: National Taiwan University Hospital
investigator title: Professor Ho-Hsiung Lin
mesh term: Lower Urinary Tract Symptoms