<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/NCT02996968</url>
  </required_header>
  <id_info>
    <org_study_id>16-075</org_study_id>
    <nct_id>NCT02996968</nct_id>
  </id_info>
  <brief_title>Self-discontinuation of a Transurethral Catheter</brief_title>
  <official_title>Is Self-discontinuation of a Transurethral Catheter Following Pelvic Reconstructive Surgery as Effective as Office-based Discontinuation?; A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TriHealth Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TriHealth Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to determine if self-discontinuation of transurethral foley catheters in&#xD;
      patients diagnosed with postoperative urinary retention (POUR), which is defined as the&#xD;
      continued need for catheterization, following impatient pelvic organ prolapse surgery is&#xD;
      non-inferior to office-discontinuation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative urinary retention (POUR) is a common issue following urogynecologic surgery,&#xD;
      with incidence rates of 1.4-43%. The wide range of incidence is due to the lack of a&#xD;
      standardized definition of POUR. Generally speaking, POUR can be characterized by any&#xD;
      impairment in bladder emptying following surgery. While the gold standard for assessing&#xD;
      voiding function remains measurement of a postvoid residual (PVR), there are many voiding&#xD;
      trial (VT) methods being used across institutions.&#xD;
&#xD;
      Historically, the most widely accepted postoperative VT for the assessment of voiding&#xD;
      function was the backfill method. An alternative assessment of voiding function is the&#xD;
      spontaneous VT, where the indwelling catheter is removed and a patient is asked to void&#xD;
      spontaneously when a patient has the urge. It is controversial which of these methods are&#xD;
      superior, and studies are conflicted. Nevertheless, both of these methods were studied in a&#xD;
      clinical setting, and we lack information on self-discontinuation efficacy at home.&#xD;
&#xD;
      Managing an indwelling urinary catheter and returning to the outpatient clinic only a week&#xD;
      after discharge from the hospital can be overwhelming for patients and their involved&#xD;
      caregivers. Given the low incidence of POUR at one-week postoperative and patient&#xD;
      dissatisfaction with urinary catheter management, home self-removal of indwelling urinary&#xD;
      catheters is an important topic of investigation.&#xD;
&#xD;
      We are trying to compare the incidence of POUR between self-discontinuation and&#xD;
      office-discontinuation of urinary catheters. The results of this study could impact on the&#xD;
      decision regarding catheter use following inpatient pelvic organ prolapse surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2017</start_date>
  <completion_date type="Actual">May 16, 2019</completion_date>
  <primary_completion_date type="Actual">May 16, 2019</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Postoperative Urinary Retention</measure>
    <time_frame>postoperative day 6-8</time_frame>
    <description>Number of Participants with postoperative urinary retention (POUR) following pelvic reconstructive surgery for pelvic organ prolapse.&#xD;
Pour at 1-week was defined as continued catheterization on POD 6-8</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">158</enrollment>
  <condition>Postoperative Urinary Retention</condition>
  <arm_group>
    <arm_group_label>Self-removal group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients randomized to the self-removal group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Office-removal group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The patients randomized to the office-removal group will visit the office for a repeat voiding trial on postoperative day 6-8 (postoperative day 7 will be encouraged). At this visit, the patients will undergo a backfill voiding trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Self-removal</intervention_name>
    <description>Self-discontinuation of a transurethral catheter</description>
    <arm_group_label>Self-removal group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing vaginal vault suspension or robot-assisted laparoscopic sacrocolpopexy by a&#xD;
             physician at Cincinnati Urogynecology Associates, TriHealth Inc.for the treatment of&#xD;
             pelvic organ prolapse&#xD;
&#xD;
          -  Failed voiding trial prior to discharge&#xD;
&#xD;
          -  Concomitant procedures such as hysterectomy, suburethral sling, anterior or posterior&#xD;
             colporrhaphy, bilateral salpingectomy or salpingooophorectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  physical or mental impairment that would affect the subject's ability to self-remove&#xD;
             indwelling urinary catheter, including patient's with Multiple Sclerosis, Dementia,&#xD;
             Parkinsonism, or those who have impaired mobility or are wheelchair bound&#xD;
&#xD;
          -  Bladder injury, fistula repair or other need for prolonged catheterization&#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>Rachel Pauls, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TriHealth - Cincinnati Urogynecology Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Urogynecology Associates</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <results_first_submitted>July 12, 2019</results_first_submitted>
  <results_first_submitted_qc>November 7, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 12, 2019</results_first_posted>
  <last_update_submitted>November 7, 2019</last_update_submitted>
  <last_update_submitted_qc>November 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Retention</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT02996968/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Self-discontinuation Group</title>
          <description>The patients randomized to the self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 7.</description>
        </group>
        <group group_id="P2">
          <title>Office-discontinuation Group</title>
          <description>The patients randomized to the office-discontinuation group will visit the office for a repeat voiding trial on postoperative day 6-8 (postoperative day 7 will be encouraged). At this visit, the patients will undergo a backfill voiding trial.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="79"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
                <participants group_id="P2" count="79"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Self-discontinuation Group</title>
          <description>The patients randomized to the self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 7.</description>
        </group>
        <group group_id="B2">
          <title>Office-discontinuation Group</title>
          <description>The patients randomized to the discontinuation group will visit the office for a repeat voiding trial on postoperative day 6-8 (postoperative day 7 will be encouraged). At this visit, the patients will undergo a backfill voiding trial.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="78"/>
            <count group_id="B2" value="79"/>
            <count group_id="B3" value="157"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.3" spread="11.0"/>
                    <measurement group_id="B2" value="60.2" spread="12.3"/>
                    <measurement group_id="B3" value="60.7" spread="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="157"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black/African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Postoperative Urinary Retention</title>
        <description>Number of Participants with postoperative urinary retention (POUR) following pelvic reconstructive surgery for pelvic organ prolapse.&#xD;
Pour at 1-week was defined as continued catheterization on POD 6-8</description>
        <time_frame>postoperative day 6-8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Self-discontinuation Group</title>
            <description>The patients randomized to the self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 7.</description>
          </group>
          <group group_id="O2">
            <title>Office-discontinuation Group</title>
            <description>The patients randomized to the office-discontinuation group will visit the office for a repeat voiding trial on postoperative day 6-8 (postoperative day 7 will be encouraged). At this visit, the patients will undergo a backfill voiding trial.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Postoperative Urinary Retention</title>
          <description>Number of Participants with postoperative urinary retention (POUR) following pelvic reconstructive surgery for pelvic organ prolapse.&#xD;
Pour at 1-week was defined as continued catheterization on POD 6-8</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was declared if the POUR rate at 1-week with self-discontinuation was no worse than the POUR rate at 1-week with office-discontinuation, by a pre-specified margin of 15%.&#xD;
A sample size was calculated to be 74 patients in each arm based on the following:&#xD;
The estimated POUR requiring indwelling urinary catheter at 1-week postoperative is 16%&#xD;
The non-inferiority margin was set at 15%.&#xD;
The power was set at 80%</non_inferiority_desc>
            <p_value>0.5</p_value>
            <p_value_desc>2-sample test for equality of proportions with continuity correction</p_value_desc>
            <method>Two proportions Z-test</method>
            <param_type>Proportion Difference</param_type>
            <param_value>0.002</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>0.095</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks postoperative</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Self-discontinuation Group</title>
          <description>The patients randomized to the self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 7.</description>
        </group>
        <group group_id="E2">
          <title>Office-discontinuation Group</title>
          <description>The patients randomized to the office-discontinuation group will visit the office for a repeat voiding trial on postoperative day 6-8 (postoperative day 7 will be encouraged). At this visit, the patients will undergo a backfill voiding trial.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Abigail Shatkin-Margolis, MD</name_or_title>
      <organization>TriHealth Inc.</organization>
      <phone>513-463-4300</phone>
      <email>Abigail_Shatkin-margolis@trihealth.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02996968
org study id: 16-075
nct id: NCT02996968
lead sponsor: 
has dmc: No
This study is to determine if self-discontinuation of transurethral foley catheters in
      patients diagnosed with postoperative urinary retention (POUR), which is defined as the
      continued need for catheterization, following impatient pelvic organ prolapse surgery is
      non-inferior to office-discontinuation.
Postoperative urinary retention (POUR) is a common issue following urogynecologic surgery,
      with incidence rates of 1.4-43%. The wide range of incidence is due to the lack of a
      standardized definition of POUR. Generally speaking, POUR can be characterized by any
      impairment in bladder emptying following surgery. While the gold standard for assessing
      voiding function remains measurement of a postvoid residual (PVR), there are many voiding
      trial (VT) methods being used across institutions.

      Historically, the most widely accepted postoperative VT for the assessment of voiding
      function was the backfill method. An alternative assessment of voiding function is the
      spontaneous VT, where the indwelling catheter is removed and a patient is asked to void
      spontaneously when a patient has the urge. It is controversial which of these methods are
      superior, and studies are conflicted. Nevertheless, both of these methods were studied in a
      clinical setting, and we lack information on self-discontinuation efficacy at home.

      Managing an indwelling urinary catheter and returning to the outpatient clinic only a week
      after discharge from the hospital can be overwhelming for patients and their involved
      caregivers. Given the low incidence of POUR at one-week postoperative and patient
      dissatisfaction with urinary catheter management, home self-removal of indwelling urinary
      catheters is an important topic of investigation.

      We are trying to compare the incidence of POUR between self-discontinuation and
      office-discontinuation of urinary catheters. The results of this study could impact on the
      decision regarding catheter use following inpatient pelvic organ prolapse surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of Participants With Postoperative Urinary Retention
time frame: postoperative day 6-8
description: Number of Participants with postoperative urinary retention (POUR) following pelvic reconstructive surgery for pelvic organ prolapse.
Pour at 1-week was defined as continued catheterization on POD 6-8
arm group label: Self-removal group
arm group type: Experimental
description: The patients randomized to the self-removal group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 7.
arm group label: Office-removal group
arm group type: No Intervention
description: The patients randomized to the office-removal group will visit the office for a repeat voiding trial on postoperative day 6-8 (postoperative day 7 will be encouraged). At this visit, the patients will undergo a backfill voiding trial.
intervention type: Procedure
intervention name: Self-removal
description: Self-discontinuation of a transurethral catheter
arm group label: Self-removal group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rachel Pauls, MD
role: Principal Investigator
affiliation: TriHealth - Cincinnati Urogynecology Associates
facility: 
country: United States
responsible party type: Sponsor
mesh term: Urinary Retention
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 