xml: <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/NCT05981794</url>
    </required_header>
    <id_info>
      <org_study_id>HSC20230455H</org_study_id>
      <nct_id>NCT05981794</nct_id>
    </id_info>
    <brief_title>Heating Pad for in Office Cystoscopy and Urodynamic Testing</brief_title>
    <official_title>The Effects of a Heating Pad on Anxiety, Pain, and Distress During In-office Cystoscopy and Urodynamics: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas Health Science Center at San Antonio</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The University of Texas Health Science Center at San Antonio</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Patient frequently report experiencing discomfort associated with cystoscopy or urodynamic&#xD;
        studies (UDS), and a small percentage of patients refuse these important procedures due to&#xD;
        discomfort or fear of discomfort. Heating pads are an inexpensive and low-risk way to reduce&#xD;
        patient discomfort during these procedures, which to our knowledge has not been investigated&#xD;
        in the United States.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Invasive office procedures such as cystoscopy and urodynamic studies (UDS) are commonly&#xD;
        performed for many urologic and Urogynecologic conditions including, but not limited to,&#xD;
        incontinence, voiding dysfunction, urinary retention, hematuria, and other lower urinary&#xD;
        tract symptoms. Cystoscopy involves the insertion of a rigid or flexible cystoscope through&#xD;
        the urethra and into the bladder. Urodynamic studies involve the placement of urethral and&#xD;
        rectal catheters. Both cystoscopy and UDS involve filling the bladder with fluid, and these&#xD;
        procedures are essential to the diagnosis and management of many of the conditions listed&#xD;
        above.&#xD;
  &#xD;
        While both procedures are office procedures that are generally well tolerated, some patients&#xD;
        can experience significant discomfort, pain, or anxiety. Some nonpharmacologic therapies have&#xD;
        been investigated to relieve anxiety, pain, and distress, such as music and aromatherapy.&#xD;
        Heating treatments are also known to reduce muscle pain by increasing local blood flow and&#xD;
        decreasing distress. The use of a heating pad has become an established complementary&#xD;
        modality in some invasive procedures. A previous study from South Korea has shown benefit of&#xD;
        heating pad use for anxiety, pain, and distress during cystoscopy and UDS; however to our&#xD;
        knowledge, there are no studies evaluating the effect of heating pad use on patients in the&#xD;
        United States, who may have inherent demographical differences compared to patients from&#xD;
        South Korea.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Patients will be randomized in a 1:1 manner to the treatment group (those receiving a heating pad with heat during the procedure) or control group (those who receive a heating pad without heat). The study is prospective, and randomization will be performed by a random allocation table. Randomization will be stratified by sex, procedure, and provider.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Anxiety visual analog scale (VAS)</measure>
      <time_frame>Pre- and Post-procedure (about 30 minutes)</time_frame>
      <description>Change in score on a 10-point visual analog scale where where 0 indicates the least amount of anxiety and 10 the greatest</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hospital Anxiety and Depression Survey (HADS)</measure>
      <time_frame>Pre- and Post-procedure (about 30 minutes)</time_frame>
      <description>Change in score on the anxiety subscale score, a total score of 0-21 is possible, with a score between 0-7= Normal, 8-10= Borderline abnormal and 11-21= abnormal</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Pain (VAS)</measure>
      <time_frame>Pre- and Post-procedure (about 30 minutes)</time_frame>
      <description>Change in score on a visual analog scale (VAS) from 0-10, where 0 indicates the least amount of pain and 10 the greatest</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Distress (VAS)</measure>
      <time_frame>Pre- and Post-procedure (about 30 minutes)</time_frame>
      <description>Change in score on a visual analog scale (VAS) from 0-10, where 0 indicates the least amount of distress and 10 the greatest</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Blood pressure measure</measure>
      <time_frame>Pre- and Post-procedure (about 30 minutes)</time_frame>
      <description>Change in blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heart rate</measure>
      <time_frame>Pre- and Post-procedure (about 30 minutes)</time_frame>
      <description>Change in heart rate</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Wait time</measure>
      <time_frame>Pre-procedure to beginning of procedure (about 30 minutes)</time_frame>
      <description>Amount of time spent waiting prior to procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time spent on procedure</measure>
      <time_frame>Pre- to Post-procedure (about 30 minutes)</time_frame>
      <description>Amount of time taken to complete procedure</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">192</enrollment>
    <condition>Anxiety</condition>
    <condition>Pain</condition>
    <condition>Distress, Emotional</condition>
    <arm_group>
      <arm_group_label>Heating Pad heated</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>An electrical heating pad will be applied prior to the cystoscopy or urodynamic procedure</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo heating pad</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>An electrical heating pad that is not heated will be applied prior to the cystoscopy or urodynamic procedure</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Electrical heating pad</intervention_name>
      <description>A powered heating pad</description>
      <arm_group_label>Heating Pad heated</arm_group_label>
      <other_name>Heating pad</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sham heating pad</intervention_name>
      <description>A heating pad that is not powered on</description>
      <arm_group_label>Placebo heating pad</arm_group_label>
      <other_name>Non-heated heating pad</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years or older&#xD;
  &#xD;
            -  Able to give informed consent&#xD;
  &#xD;
            -  Able to read and write English or Spanish&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal to participate&#xD;
  &#xD;
            -  Contraindications to cystoscopy or urodynamic testing&#xD;
  &#xD;
            -  Patients who receive other procedures or treatment at the time of cystoscopy, such as&#xD;
               bladder biopsy or Botox injection&#xD;
  &#xD;
            -  Patients with spinal cord injury or lack of sensation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jun Song, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Texas Health Science Center San Antonio</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jun Song, MD</last_name>
      <phone>615-686-9648</phone>
      <email>Songj5@uthscsa.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Texas Health Science Center at San Antonio</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78229</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 22, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of Texas Health Science Center at San Antonio</investigator_affiliation>
      <investigator_full_name>Jun Song</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Cystoscopy</keyword>
    <keyword>Urodynamic study</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All de-identified IPD that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>When summary data are published or otherwise made available at study completion</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05981794
  org study id: HSC20230455H
  nct id: NCT05981794
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  Patient frequently report experiencing discomfort associated with cystoscopy or urodynamic
        studies (UDS), and a small percentage of patients refuse these important procedures due to
        discomfort or fear of discomfort. Heating pads are an inexpensive and low-risk way to reduce
        patient discomfort during these procedures, which to our knowledge has not been investigated
        in the United States.
  Invasive office procedures such as cystoscopy and urodynamic studies (UDS) are commonly
        performed for many urologic and Urogynecologic conditions including, but not limited to,
        incontinence, voiding dysfunction, urinary retention, hematuria, and other lower urinary
        tract symptoms. Cystoscopy involves the insertion of a rigid or flexible cystoscope through
        the urethra and into the bladder. Urodynamic studies involve the placement of urethral and
        rectal catheters. Both cystoscopy and UDS involve filling the bladder with fluid, and these
        procedures are essential to the diagnosis and management of many of the conditions listed
        above.
  
        While both procedures are office procedures that are generally well tolerated, some patients
        can experience significant discomfort, pain, or anxiety. Some nonpharmacologic therapies have
        been investigated to relieve anxiety, pain, and distress, such as music and aromatherapy.
        Heating treatments are also known to reduce muscle pain by increasing local blood flow and
        decreasing distress. The use of a heating pad has become an established complementary
        modality in some invasive procedures. A previous study from South Korea has shown benefit of
        heating pad use for anxiety, pain, and distress during cystoscopy and UDS; however to our
        knowledge, there are no studies evaluating the effect of heating pad use on patients in the
        United States, who may have inherent demographical differences compared to patients from
        South Korea.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients will be randomized in a 1:1 manner to the treatment group (those receiving a heating pad with heat during the procedure) or control group (those who receive a heating pad without heat). The study is prospective, and randomization will be performed by a random allocation table. Randomization will be stratified by sex, procedure, and provider.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Anxiety visual analog scale (VAS)
  time frame: Pre- and Post-procedure (about 30 minutes)
  description: Change in score on a 10-point visual analog scale where where 0 indicates the least amount of anxiety and 10 the greatest
  measure: Hospital Anxiety and Depression Survey (HADS)
  time frame: Pre- and Post-procedure (about 30 minutes)
  description: Change in score on the anxiety subscale score, a total score of 0-21 is possible, with a score between 0-7= Normal, 8-10= Borderline abnormal and 11-21= abnormal
  measure: Change in Pain (VAS)
  time frame: Pre- and Post-procedure (about 30 minutes)
  description: Change in score on a visual analog scale (VAS) from 0-10, where 0 indicates the least amount of pain and 10 the greatest
  measure: Change in Distress (VAS)
  time frame: Pre- and Post-procedure (about 30 minutes)
  description: Change in score on a visual analog scale (VAS) from 0-10, where 0 indicates the least amount of distress and 10 the greatest
  measure: Blood pressure measure
  time frame: Pre- and Post-procedure (about 30 minutes)
  description: Change in blood pressure
  measure: Heart rate
  time frame: Pre- and Post-procedure (about 30 minutes)
  description: Change in heart rate
  measure: Wait time
  time frame: Pre-procedure to beginning of procedure (about 30 minutes)
  description: Amount of time spent waiting prior to procedure
  measure: Time spent on procedure
  time frame: Pre- to Post-procedure (about 30 minutes)
  description: Amount of time taken to complete procedure
  arm group label: Heating Pad heated
  arm group type: Experimental
  description: An electrical heating pad will be applied prior to the cystoscopy or urodynamic procedure
  arm group label: Placebo heating pad
  arm group type: Placebo Comparator
  description: An electrical heating pad that is not heated will be applied prior to the cystoscopy or urodynamic procedure
  intervention type: Device
  intervention name: Electrical heating pad
  description: A powered heating pad
  arm group label: Heating Pad heated
  other name: Heating pad
  intervention type: Device
  intervention name: Sham heating pad
  description: A heating pad that is not powered on
  arm group label: Placebo heating pad
  other name: Non-heated heating pad
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jun Song, MD
  role: Principal Investigator
  affiliation: University of Texas Health Science Center San Antonio
  last name: Jun Song, MD
  phone: 615-686-9648
  email: Songj5@uthscsa.edu
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The University of Texas Health Science Center at San Antonio
  investigator full name: Jun Song
  investigator title: Principal Investigator
  mesh term: Anxiety Disorders
  sharing ipd: Yes
  ipd description: All de-identified IPD that underlie results in a publication
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: When summary data are published or otherwise made available at study completion