<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/NCT01663181</url>
  </required_header>
  <id_info>
    <org_study_id>413/2009</org_study_id>
    <nct_id>NCT01663181</nct_id>
  </id_info>
  <brief_title>Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study</brief_title>
  <official_title>Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      At an academic tertiary referral center, patients with pelvic floor dysfunction, scheduled&#xD;
      for outpatient cystoscopy or urodynamic testing will be asked to participate in the study.&#xD;
      Patients will be called one day after the examination and will be asked about pain and their&#xD;
      general state of health.&#xD;
&#xD;
      The purpose of this study it to investigate pain perception in urogynecologic patients during&#xD;
      outpatient cystoscopy and compare it with pain perception during outpatient urodynamic. The&#xD;
      investigators will also investigate the difference between anticipated and actual pain&#xD;
      perception. The investigators will test the null hypothesis that there is no difference in&#xD;
      patients´ pain perception between outpatient cystoscopy and urodynamic testing. The secondary&#xD;
      hypothesis will be that there is no difference between patients´ anticipated amount of pain&#xD;
      and the actually experienced pain during cystoscopy and urodynamic testing.&#xD;
&#xD;
      According to power calculation, a sample size of 52 patients per group will be needed to&#xD;
      detect a 2 cm difference in pain scores on the VAS - judged as a clinically significant&#xD;
      difference - with 95% power and a two-sided significance level of 0.05.&#xD;
&#xD;
      Exclusion criteria are: age ≤ 18 years, insufficient ability to understand German, pregnancy&#xD;
      and the participation in another clinical study at the same time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2009</start_date>
  <completion_date type="Actual">April 2010</completion_date>
  <primary_completion_date type="Actual">February 2010</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>
  <primary_outcome>
    <measure>subjective pain perception immediately after examination as measured by a standard visual analog scale</measure>
    <time_frame>immediately after examination (zero to ten minutes after completing cystoscopy or urodynamics)</time_frame>
    <description>patients are assessed at three points in time:&#xD;
zero to ten minutes before undergoing examination&#xD;
zero to ten minutes after undergoing examination&#xD;
24 hours after undergoing examination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>difference between anticipated pain and actual pain perception</measure>
    <time_frame>immediately before and immediately after the examination (zero to ten minutes after undergoing examination)</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">109</enrollment>
  <condition>Urinary Incontinence</condition>
  <condition>Overactive Bladder</condition>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Recurrent Urinary Tract Infections</condition>
  <arm_group>
    <arm_group_label>urogynecologic patients undergoing outpatient cystoscopy</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>urogynecologic patients undergoing outpatient-urodynamics</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        women, aged &gt;= 18 years with pelvic floor dysfunction, undergoing diagnostic work-up at a&#xD;
        tertiary referral center for urogynecologic conditions&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women undergoing cystoscopy or urodynamic testing at an academic tertiary referral&#xD;
             center.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age ≤ 18 years&#xD;
&#xD;
          -  insufficient ability to understand German&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  participation in another clinical study at the same time&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wolfgang Umek, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Vienna Austria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 5, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>April 8, 2022</last_update_submitted>
  <last_update_submitted_qc>April 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Wolfgang Umek, MD</investigator_full_name>
    <investigator_title>ao.Univ.Prof.Dr.univ.med</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Tract Infections</mesh_term>
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</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/NCT01663181
org study id: 413/2009
nct id: NCT01663181
lead sponsor: 
has dmc: No
At an academic tertiary referral center, patients with pelvic floor dysfunction, scheduled
      for outpatient cystoscopy or urodynamic testing will be asked to participate in the study.
      Patients will be called one day after the examination and will be asked about pain and their
      general state of health.

      The purpose of this study it to investigate pain perception in urogynecologic patients during
      outpatient cystoscopy and compare it with pain perception during outpatient urodynamic. The
      investigators will also investigate the difference between anticipated and actual pain
      perception. The investigators will test the null hypothesis that there is no difference in
      patients´ pain perception between outpatient cystoscopy and urodynamic testing. The secondary
      hypothesis will be that there is no difference between patients´ anticipated amount of pain
      and the actually experienced pain during cystoscopy and urodynamic testing.

      According to power calculation, a sample size of 52 patients per group will be needed to
      detect a 2 cm difference in pain scores on the VAS - judged as a clinically significant
      difference - with 95% power and a two-sided significance level of 0.05.

      Exclusion criteria are: age ≤ 18 years, insufficient ability to understand German, pregnancy
      and the participation in another clinical study at the same time.
observational model: Cohort
time perspective: Prospective
measure: subjective pain perception immediately after examination as measured by a standard visual analog scale
time frame: immediately after examination (zero to ten minutes after completing cystoscopy or urodynamics)
description: patients are assessed at three points in time:
zero to ten minutes before undergoing examination
zero to ten minutes after undergoing examination
24 hours after undergoing examination
measure: difference between anticipated pain and actual pain perception
time frame: immediately before and immediately after the examination (zero to ten minutes after undergoing examination)
arm group label: urogynecologic patients undergoing outpatient cystoscopy
arm group label: urogynecologic patients undergoing outpatient-urodynamics
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wolfgang Umek, Prof
role: Principal Investigator
affiliation: Medical University Vienna Austria
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Wolfgang Umek, MD
investigator title: ao.Univ.Prof.Dr.univ.med
mesh term: Urinary Tract Infections
mesh term: Urinary Incontinence
mesh term: Urinary Bladder, Overactive
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse