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/NCT06038448</url>
    </required_header>
    <id_info>
      <org_study_id>TCRD112-017</org_study_id>
      <nct_id>NCT06038448</nct_id>
    </id_info>
    <brief_title>Efficacy of Reduction of the Balloon Volume for Prevention of Postoperative Catheter-related Bladder Discomfort in Patients Undergoing Non-lower Urinary Tract Surgery</brief_title>
    <official_title>Efficacy of Reduction of the Balloon Volume for Prevention of Postoperative Catheter-related Bladder Discomfort in Patients Undergoing Non-lower Urinary Tract Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Buddhist Tzu Chi General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Buddhist Tzu Chi General Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        CRBD is related to different degrees of irritation caused by the volume of the balloon in the&#xD;
        urinary catheter, and when CRBD occurs, it may cause severe postoperative pain and trauma by&#xD;
        self-removal of the catheter, further leading complications. Although many drugs can improve&#xD;
        CRBD, measures that can be immediately intervened by non-nursing staff at any time and even&#xD;
        have different side effects on patients due to drug use.Therefore, the author wants to use&#xD;
        this study to explore the reduction of catheter balloon volume can effectively reduce the&#xD;
        degree of CRBD, is a non-invasive and immediately executable nursing treatment.the quality of&#xD;
        clinical care and hospitalization of the patient can be further improved, reducing the&#xD;
        patient's inappropriate, thereby improving the quality of medical care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Catheter-Related Bladder Discomfort (CRBD) has been attached importance in recent years.&#xD;
        Reducing the discomfort of patients with effective treatment is a part of our medical and&#xD;
        nursing care that needs to be paid more attention to. The literature has pointed out that&#xD;
        CRBD is related to different degrees of irritation caused by the volume of the balloon in the&#xD;
        urinary catheter, and when CRBD occurs, it may cause severe postoperative pain and trauma by&#xD;
        self-removal of the catheter, further leading to urethral injury and subsequent urethral&#xD;
        stricture, and complications such as bleeding, surgical wound dehiscence, and arrhythmia.&#xD;
        Although many drugs can improve CRBD, measures that can be immediately intervened by&#xD;
        non-nursing staff at any time and even have different side effects on patients due to drug&#xD;
        use.&#xD;
  &#xD;
        In the past 20 years, only one piece of literature has discussed the effect of catheter&#xD;
        balloon volume on CRBD, and the sample size is relatively small and even not related to the&#xD;
        Asian region. Therefore, the author wants to use this study to explore the reduction of&#xD;
        catheter balloon volume can effectively reduce the degree of CRBD, in addition to reducing&#xD;
        the side effects of patients due to drug use, is a non-invasive and immediately executable&#xD;
        nursing treatment.&#xD;
  &#xD;
        Further, if post-evidence nursing intervention can effectively reduce the CRBD generated,&#xD;
        thereby increasing the patient's comfort, and allowing the patient to cooperate more with the&#xD;
        treatment to achieve an effective therapeutic effect, thereby improving the quality of care&#xD;
        and the enlargement of recovery.&#xD;
  &#xD;
        Eventually, the quality of clinical care and hospitalization of the patient can be further&#xD;
        improved, reducing the patient's inappropriate, thereby improving the quality of medical&#xD;
        care.&#xD;
  &#xD;
        Key words: Catheter-Related Bladder Discomfort, urinary catheter, balloon, nursing&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 6, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>parallel into two groups, each urinary catheter balloon size 10mL and 5mL</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Degree of Catheter-related Bladder Discomfort</measure>
      <time_frame>Return to the ward after surgery O hours.3 hours.12 hours</time_frame>
      <description>Likert scale 0.1.2.3</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Visual analog scale for pain severity</measure>
      <time_frame>Return to the ward after surgery O hours.3 hours.12 hours</time_frame>
      <description>0 to 10</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Catheter-Related Bladder Discomfort</condition>
    <condition>Urinary Catheter</condition>
    <arm_group>
      <arm_group_label>Effect of normal 10ml balloon volume on postoperative CRBD in non-LUTS patients</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Efficacy of normal 10ml balloon volume for prevention of postoperative catheter-related bladder discomfort in patients undergoing non-lower urinary tract surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Effect of reduction of 5ml balloon volume for postoperative CRBD in patients undergoing non-LUTS</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Efficacy of reduction of 5ml the balloon volume for prevention of postoperative catheter-related bladder discomfort in patients undergoing non-lower urinary tract surgery</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Urinary catheter balloon size</intervention_name>
      <description>We will collect 120 participants divided into two groups ,in different procedure(stone procedure, herniarraphy, nephrectomy), and we used different urinary catheter balloon size(10ml and 5ml), tp investigate the patient with the severity of catheter-related bladder discomfort.</description>
      <arm_group_label>Effect of normal 10ml balloon volume on postoperative CRBD in non-LUTS patients</arm_group_label>
      <arm_group_label>Effect of reduction of 5ml balloon volume for postoperative CRBD in patients undergoing non-LUTS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age from 20-80 year-old&#xD;
  &#xD;
            -  in urological surgery under the general anesthesia&#xD;
  &#xD;
            -  2 arms: (1)non-lower urinary tract surgery: hernia, and nephrectomy surgery , (2)&#xD;
               lower urinary tract surgery: stone surgery after ureter catheter insertion.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients not undergoing hernia repair or nephrectomy.&#xD;
  &#xD;
            -  Patients who are not undergoing ureteral lithotripsy and renal stone extraction.&#xD;
  &#xD;
            -  Those who are already using drugs for overactive bladder or prostatic hypertrophy.&#xD;
  &#xD;
            -  Retrograde intrarenal surgery (RIRS) for stone extraction.&#xD;
  &#xD;
            -  People with dementia.&#xD;
  &#xD;
            -  Patients with cognitive impairment.&#xD;
  &#xD;
            -  Patients with impaired consciousness.&#xD;
  &#xD;
            -  Patients who are unable to communicate verbally.&#xD;
  &#xD;
            -  The subject had participated in other experimental drug trials one month before the&#xD;
               study entered.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ou Shiuan-Ru, Head Nurse</last_name>
      <phone>+886 38561825</phone>
      <email>qp761009@gmail.com</email>
    </overall_contact>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>urinary catheter</keyword>
    <keyword>Catheter-Related Bladder Discomfort</keyword>
    <keyword>balloon</keyword>
    <keyword>nursing</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06038448
  org study id: TCRD112-017
  nct id: NCT06038448
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  CRBD is related to different degrees of irritation caused by the volume of the balloon in the
        urinary catheter, and when CRBD occurs, it may cause severe postoperative pain and trauma by
        self-removal of the catheter, further leading complications. Although many drugs can improve
        CRBD, measures that can be immediately intervened by non-nursing staff at any time and even
        have different side effects on patients due to drug use.Therefore, the author wants to use
        this study to explore the reduction of catheter balloon volume can effectively reduce the
        degree of CRBD, is a non-invasive and immediately executable nursing treatment.the quality of
        clinical care and hospitalization of the patient can be further improved, reducing the
        patient's inappropriate, thereby improving the quality of medical care.
  Catheter-Related Bladder Discomfort (CRBD) has been attached importance in recent years.
        Reducing the discomfort of patients with effective treatment is a part of our medical and
        nursing care that needs to be paid more attention to. The literature has pointed out that
        CRBD is related to different degrees of irritation caused by the volume of the balloon in the
        urinary catheter, and when CRBD occurs, it may cause severe postoperative pain and trauma by
        self-removal of the catheter, further leading to urethral injury and subsequent urethral
        stricture, and complications such as bleeding, surgical wound dehiscence, and arrhythmia.
        Although many drugs can improve CRBD, measures that can be immediately intervened by
        non-nursing staff at any time and even have different side effects on patients due to drug
        use.
  
        In the past 20 years, only one piece of literature has discussed the effect of catheter
        balloon volume on CRBD, and the sample size is relatively small and even not related to the
        Asian region. Therefore, the author wants to use this study to explore the reduction of
        catheter balloon volume can effectively reduce the degree of CRBD, in addition to reducing
        the side effects of patients due to drug use, is a non-invasive and immediately executable
        nursing treatment.
  
        Further, if post-evidence nursing intervention can effectively reduce the CRBD generated,
        thereby increasing the patient's comfort, and allowing the patient to cooperate more with the
        treatment to achieve an effective therapeutic effect, thereby improving the quality of care
        and the enlargement of recovery.
  
        Eventually, the quality of clinical care and hospitalization of the patient can be further
        improved, reducing the patient's inappropriate, thereby improving the quality of medical
        care.
  
        Key words: Catheter-Related Bladder Discomfort, urinary catheter, balloon, nursing
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: parallel into two groups, each urinary catheter balloon size 10mL and 5mL
  primary purpose: Prevention
  masking: Single (Participant)
  measure: Degree of Catheter-related Bladder Discomfort
  time frame: Return to the ward after surgery O hours.3 hours.12 hours
  description: Likert scale 0.1.2.3
  measure: Visual analog scale for pain severity
  time frame: Return to the ward after surgery O hours.3 hours.12 hours
  description: 0 to 10
  arm group label: Effect of normal 10ml balloon volume on postoperative CRBD in non-LUTS patients
  arm group type: Active Comparator
  description: Efficacy of normal 10ml balloon volume for prevention of postoperative catheter-related bladder discomfort in patients undergoing non-lower urinary tract surgery
  arm group label: Effect of reduction of 5ml balloon volume for postoperative CRBD in patients undergoing non-LUTS
  arm group type: Active Comparator
  description: Efficacy of reduction of 5ml the balloon volume for prevention of postoperative catheter-related bladder discomfort in patients undergoing non-lower urinary tract surgery
  intervention type: Procedure
  intervention name: Urinary catheter balloon size
  description: We will collect 120 participants divided into two groups ,in different procedure(stone procedure, herniarraphy, nephrectomy), and we used different urinary catheter balloon size(10ml and 5ml), tp investigate the patient with the severity of catheter-related bladder discomfort.
  arm group label: Effect of normal 10ml balloon volume on postoperative CRBD in non-LUTS patients
  arm group label: Effect of reduction of 5ml balloon volume for postoperative CRBD in patients undergoing non-LUTS
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Ou Shiuan-Ru, Head Nurse
  phone: +886 38561825
  email: qp761009@gmail.com
  responsible party type: Sponsor
  sharing ipd: No