<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/NCT03023241</url>
  </required_header>
  <id_info>
    <org_study_id>9900.013 BPS/IC study</org_study_id>
    <secondary_id>KEKTGOV2010/01</secondary_id>
    <nct_id>NCT03023241</nct_id>
  </id_info>
  <brief_title>Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis</brief_title>
  <official_title>Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cantonal Hospital, Frauenfeld</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cantonal Hospital, Frauenfeld</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To identify new, simple and reliable biomarkers for bladder pain syndrome/interstitial&#xD;
      cystitis (BPS/IC) for diagnosis of this disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Collection and analyses of bladder biopsies, bladder washings, blood and urine samples of&#xD;
      patients with bladder pain syndrome/interstitial cystitis (BPS/IC), overactive bladder&#xD;
      syndrome (OAB) and bladder-healthy controls. Analyses include ELISA, RT-qPCR, DNA sequencing,&#xD;
      and immunohistochemistry techniques. Differences between patient groups are statistically&#xD;
      evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2004</start_date>
  <completion_date type="Actual">July 2021</completion_date>
  <primary_completion_date type="Actual">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Identification of new diagnostic markers for BPS/IC</measure>
    <time_frame>2 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification of molecular details that lead to BPS/IC (pathogenesis).</measure>
    <time_frame>2 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Bladder Pain Syndrome</condition>
  <condition>Interstitial Cystitis</condition>
  <condition>Overactive Bladder</condition>
  <arm_group>
    <arm_group_label>all study patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Same intervention for all subjects: anamnesis, questionnaires and biological samples (bladder biopsy, bladder washing, blood and urine) are collected at one single visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>biopsy</intervention_name>
    <description>cold cup bladder biopsies and bladder washings under anesthesia, blood and urine collection</description>
    <arm_group_label>all study patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient with diagnosed BPS/IC, OAB or healthy controls&#xD;
&#xD;
          -  included healthy controls must have another pelvic surgery planned (e.g. hysterectomy)&#xD;
&#xD;
          -  being able to act and judge&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unstable endocrinological situation&#xD;
&#xD;
          -  severe illness&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Volker Viereck, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cantonal Hospital Frauenfeld, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cantonal Hospital Frauenfeld</name>
      <address>
        <city>Frauenfeld</city>
        <state>Thurgau</state>
        <zip>8501</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <results_reference>
    <citation>Gamper M, Viereck V, Geissbuhler V, Eberhard J, Binder J, Moll C, Rehrauer H, Moser R. Gene expression profile of bladder tissue of patients with ulcerative interstitial cystitis. BMC Genomics. 2009 Apr 28;10:199. doi: 10.1186/1471-2164-10-199.</citation>
    <PMID>19400928</PMID>
  </results_reference>
  <results_reference>
    <citation>Gamper M, Viereck V, Eberhard J, Binder J, Moll C, Welter J, Moser R. Local immune response in bladder pain syndrome/interstitial cystitis ESSIC type 3C. Int Urogynecol J. 2013 Dec;24(12):2049-57. doi: 10.1007/s00192-013-2112-0. Epub 2013 May 14.</citation>
    <PMID>23670165</PMID>
  </results_reference>
  <results_reference>
    <citation>Gamper M, Regauer S, Welter J, Eberhard J, Viereck V. Are mast cells still good biomarkers for bladder pain syndrome/interstitial cystitis? J Urol. 2015 Jun;193(6):1994-2000. doi: 10.1016/j.juro.2015.01.036. Epub 2015 Jan 14.</citation>
    <PMID>25596361</PMID>
  </results_reference>
  <results_reference>
    <citation>Gamper M, Moser R, Viereck V. Have we been led astray by the NGF biomarker data? Neurourol Urodyn. 2017 Jan;36(1):203-204. doi: 10.1002/nau.22882. Epub 2015 Sep 18. No abstract available.</citation>
    <PMID>26384156</PMID>
  </results_reference>
  <results_reference>
    <citation>Regauer S, Gamper M, Fehr MK, Viereck V. Sensory Hyperinnervation Distinguishes Bladder Pain Syndrome/Interstitial Cystitis from Overactive Bladder Syndrome. J Urol. 2017 Jan;197(1):159-166. doi: 10.1016/j.juro.2016.06.089. Epub 2016 Jul 1.</citation>
    <PMID>27378135</PMID>
  </results_reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>March 30, 2022</last_update_submitted>
  <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cantonal Hospital, Frauenfeld</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Volker Viereck</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </responsible_party>
  <keyword>BPS/IC</keyword>
  <keyword>OAB</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
    <mesh_term>Cystitis</mesh_term>
    <mesh_term>Cystitis, Interstitial</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Somatoform Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03023241
org study id: 9900.013 BPS/IC study
secondary id: KEKTGOV2010/01
nct id: NCT03023241
lead sponsor: 
has dmc: No
To identify new, simple and reliable biomarkers for bladder pain syndrome/interstitial
      cystitis (BPS/IC) for diagnosis of this disease.
Collection and analyses of bladder biopsies, bladder washings, blood and urine samples of
      patients with bladder pain syndrome/interstitial cystitis (BPS/IC), overactive bladder
      syndrome (OAB) and bladder-healthy controls. Analyses include ELISA, RT-qPCR, DNA sequencing,
      and immunohistochemistry techniques. Differences between patient groups are statistically
      evaluated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Identification of new diagnostic markers for BPS/IC
time frame: 2 days
measure: Identification of molecular details that lead to BPS/IC (pathogenesis).
time frame: 2 days
arm group label: all study patients
arm group type: Experimental
description: Same intervention for all subjects: anamnesis, questionnaires and biological samples (bladder biopsy, bladder washing, blood and urine) are collected at one single visit.
intervention type: Procedure
intervention name: biopsy
description: cold cup bladder biopsies and bladder washings under anesthesia, blood and urine collection
arm group label: all study patients
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Volker Viereck, Prof. Dr.
role: Principal Investigator
affiliation: Cantonal Hospital Frauenfeld, Switzerland
facility: 
country: Switzerland
citation: Gamper M, Viereck V, Geissbuhler V, Eberhard J, Binder J, Moll C, Rehrauer H, Moser R. Gene expression profile of bladder tissue of patients with ulcerative interstitial cystitis. BMC Genomics. 2009 Apr 28;10:199. doi: 10.1186/1471-2164-10-199.
PMID: 19400928
citation: Gamper M, Viereck V, Eberhard J, Binder J, Moll C, Welter J, Moser R. Local immune response in bladder pain syndrome/interstitial cystitis ESSIC type 3C. Int Urogynecol J. 2013 Dec;24(12):2049-57. doi: 10.1007/s00192-013-2112-0. Epub 2013 May 14.
PMID: 23670165
citation: Gamper M, Regauer S, Welter J, Eberhard J, Viereck V. Are mast cells still good biomarkers for bladder pain syndrome/interstitial cystitis? J Urol. 2015 Jun;193(6):1994-2000. doi: 10.1016/j.juro.2015.01.036. Epub 2015 Jan 14.
PMID: 25596361
citation: Gamper M, Moser R, Viereck V. Have we been led astray by the NGF biomarker data? Neurourol Urodyn. 2017 Jan;36(1):203-204. doi: 10.1002/nau.22882. Epub 2015 Sep 18. No abstract available.
PMID: 26384156
citation: Regauer S, Gamper M, Fehr MK, Viereck V. Sensory Hyperinnervation Distinguishes Bladder Pain Syndrome/Interstitial Cystitis from Overactive Bladder Syndrome. J Urol. 2017 Jan;197(1):159-166. doi: 10.1016/j.juro.2016.06.089. Epub 2016 Jul 1.
PMID: 27378135
responsible party type: Principal Investigator
investigator affiliation: Cantonal Hospital, Frauenfeld
investigator full name: Prof. Dr. Volker Viereck
investigator title: Prof. Dr. med.
mesh term: Urinary Bladder, Overactive
mesh term: Cystitis
mesh term: Cystitis, Interstitial
mesh term: Syndrome
mesh term: Somatoform Disorders
sharing ipd: No