<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/NCT03302936</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 17-0999</org_study_id>
    <nct_id>NCT03302936</nct_id>
  </id_info>
  <brief_title>Assessing Pyridium for Post-Sling Urinary Retention</brief_title>
  <official_title>A Randomized Control Trial Assessing Pyridium for Post-Sling Urinary Retention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There has been preliminary data showing that pyridium can decrease the risk of difficulty&#xD;
      urinating after midurethral sling. This study is designed to have two groups of patients. One&#xD;
      group will receive pyridium pre-operatively, while the other group will have routine&#xD;
      preoperative care. Both groups will have their bladder tested prior to going home. It will be&#xD;
      evaluated if there is a difference in the difficulty to urinate post-operatively in both&#xD;
      groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective randomized controlled trial. It will have two arms with 48 patients in&#xD;
      each arm, a total of 98 patients. Patients will be randomized with a block randomization&#xD;
      schedule generated by computerized random numbers using a 1:1 allocation to pyridium and&#xD;
      routine perioperative care. The study is powered to see a difference in incidence of urinary&#xD;
      retention after midurethral sling using 25% as the historic control for our institution.&#xD;
      Statistical sample size was based on a decrease in incidence to 5% in the pyridium arm. This&#xD;
      is with 80% power and alpha 0.05. After the patient's surgery, including a midurethral sling,&#xD;
      the patient will have an active voiding trial performed as described by Pulvino et al. The&#xD;
      patient's bladder will be backfilled with 300cc of sterile saline. If the patient cannot&#xD;
      tolerate 300cc, the patient will be filled to maximum capacity. The patient will be allowed&#xD;
      20 minutes to void. The patient must void greater than two thirds the volume that was&#xD;
      instilled in the bladder to consider it a passed voiding trial. The timing of the voiding&#xD;
      trial will be at the discretion of the surgeon, accounting for factors such as complexity of&#xD;
      concomitant surgery, the patient being alert, ambulating, with tolerable pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2017</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Considered to Have Passed Their Voiding Trial</measure>
    <time_frame>Day 1</time_frame>
    <description>Pyridium affect - A patient's bladder is backfilled with water prior to having foley removed. If they can void 200cc of 300cc instilled in the bladder, they are considered to have past their voiding trial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Urinary Retention</measure>
    <time_frame>Day 1</time_frame>
    <description>Incidence of participants that do not pass their voiding trial and go home with an indwelling foley</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Scale</measure>
    <time_frame>Day 1: 6-8 hours after surgery</time_frame>
    <description>Pain scale from 0-10. 0-being no pain, 10-being the most pain</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Urinary Retention</condition>
  <arm_group>
    <arm_group_label>Pyridium arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phenazopyridine 200mg tablet, once prior to surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention in this group. Routine perioperative care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phenazopyridine</intervention_name>
    <description>to be given preoperatively</description>
    <arm_group_label>Pyridium arm</arm_group_label>
    <other_name>Pyridium</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any female patient undergoing a midurethral sling surgery, regardless of concomitant&#xD;
             pelvic reconstructive or gynecological surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with complications from surgery requiring indwelling catheter,&#xD;
             bladder/urethral perforation requiring indwelling catheter&#xD;
&#xD;
          -  Acute bleeding requiring indwelling catheter for accurate urine output calculation&#xD;
&#xD;
          -  Patients undergoing concomitant surgery other than gynecological, preoperative voiding&#xD;
             dysfunction defined as postvoid residual &gt;150cc, or spinal anesthesia&#xD;
&#xD;
          -  Women who are pregnant, including women of childbearing age who test positive on&#xD;
             preoperative urine pregnancy test&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Ascher-Walsh, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <results_first_submitted>September 16, 2019</results_first_submitted>
  <results_first_submitted_qc>October 9, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 29, 2019</results_first_posted>
  <last_update_submitted>October 9, 2019</last_update_submitted>
  <last_update_submitted_qc>October 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Annacecilia Peacher</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Midurethral sling</keyword>
  <keyword>Pyridium</keyword>
  <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>September 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03302936/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pyridium Arm</title>
          <description>Phenazopyridine 200mg tablet, once prior to surgery&#xD;
Phenazopyridine: to be given preoperatively</description>
        </group>
        <group group_id="P2">
          <title>Control Arm Vitamin B-6 as Placebo</title>
          <description>Vitamin B-6 50mg given once prior to surgery as placebo. Routine perioperative care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pyridium Arm</title>
          <description>Phenazopyridine 200mg tablet, once prior to surgery&#xD;
Phenazopyridine: to be given preoperatively</description>
        </group>
        <group group_id="B2">
          <title>Control Arm</title>
          <description>No intervention in this group. Routine perioperative care.</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="46"/>
            <count group_id="B2" value="45"/>
            <count group_id="B3" value="91"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="28"/>
                  </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="46"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="91"/>
                  </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>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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 (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>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="46"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Menopausal status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tobacco user</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of abdominal or pelvic surgery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Considered to Have Passed Their Voiding Trial</title>
        <description>Pyridium affect - A patient's bladder is backfilled with water prior to having foley removed. If they can void 200cc of 300cc instilled in the bladder, they are considered to have past their voiding trial.</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pyridium Arm</title>
            <description>Phenazopyridine 200mg tablet, once prior to surgery&#xD;
Phenazopyridine: to be given preoperatively&#xD;
Failed void trial, 16 participants or 34.5% in the phenazopyridine arm.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Vitamin B-6 as placebo. Routine perioperative care.&#xD;
Failed void trial, 15 participants or 33.3% in the placebo arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Considered to Have Passed Their Voiding Trial</title>
          <description>Pyridium affect - A patient's bladder is backfilled with water prior to having foley removed. If they can void 200cc of 300cc instilled in the bladder, they are considered to have past their voiding trial.</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="46"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Urinary Retention</title>
        <description>Incidence of participants that do not pass their voiding trial and go home with an indwelling foley</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Urinary Retention in Pyridium</title>
            <description>Urinary retention is the same value as failed void trial in both arms</description>
          </group>
          <group group_id="O2">
            <title>Urinary Retention in Placebo</title>
            <description>Urinary retention is the same value as failed void trial</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Urinary Retention</title>
          <description>Incidence of participants that do not pass their voiding trial and go home with an indwelling foley</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="46"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Scale</title>
        <description>Pain scale from 0-10. 0-being no pain, 10-being the most pain</description>
        <time_frame>Day 1: 6-8 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pain Scale in Pyridium Arm</title>
            <description>At time of void, pain on a VAS scale from 0-10</description>
          </group>
          <group group_id="O2">
            <title>Pain Scale in Placebo Arm</title>
            <description>At time of void pain on a VAS scale from 0-10</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Scale</title>
          <description>Pain scale from 0-10. 0-being no pain, 10-being the most pain</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O2" value="3" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through day of surgery</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Pyridium</title>
          <description>Phenazopyridine 200mg tablet, once prior to surgery</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Vitamin B-6 50mg given once prior to surgery as placebo.</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="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </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="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </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>Annacecilia Peacher-Holderied</name_or_title>
      <organization>Icahn School of Medicine at Mount Sinai</organization>
      <phone>2104887216</phone>
      <email>apeacher4@gmail.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/NCT03302936
org study id: GCO 17-0999
nct id: NCT03302936
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
There has been preliminary data showing that pyridium can decrease the risk of difficulty
      urinating after midurethral sling. This study is designed to have two groups of patients. One
      group will receive pyridium pre-operatively, while the other group will have routine
      preoperative care. Both groups will have their bladder tested prior to going home. It will be
      evaluated if there is a difference in the difficulty to urinate post-operatively in both
      groups.
This is a prospective randomized controlled trial. It will have two arms with 48 patients in
      each arm, a total of 98 patients. Patients will be randomized with a block randomization
      schedule generated by computerized random numbers using a 1:1 allocation to pyridium and
      routine perioperative care. The study is powered to see a difference in incidence of urinary
      retention after midurethral sling using 25% as the historic control for our institution.
      Statistical sample size was based on a decrease in incidence to 5% in the pyridium arm. This
      is with 80% power and alpha 0.05. After the patient's surgery, including a midurethral sling,
      the patient will have an active voiding trial performed as described by Pulvino et al. The
      patient's bladder will be backfilled with 300cc of sterile saline. If the patient cannot
      tolerate 300cc, the patient will be filled to maximum capacity. The patient will be allowed
      20 minutes to void. The patient must void greater than two thirds the volume that was
      instilled in the bladder to consider it a passed voiding trial. The timing of the voiding
      trial will be at the discretion of the surgeon, accounting for factors such as complexity of
      concomitant surgery, the patient being alert, ambulating, with tolerable pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Number of Participants Considered to Have Passed Their Voiding Trial
time frame: Day 1
description: Pyridium affect - A patient's bladder is backfilled with water prior to having foley removed. If they can void 200cc of 300cc instilled in the bladder, they are considered to have past their voiding trial.
measure: Incidence of Urinary Retention
time frame: Day 1
description: Incidence of participants that do not pass their voiding trial and go home with an indwelling foley
measure: Pain Scale
time frame: Day 1: 6-8 hours after surgery
description: Pain scale from 0-10. 0-being no pain, 10-being the most pain
arm group label: Pyridium arm
arm group type: Experimental
description: Phenazopyridine 200mg tablet, once prior to surgery
arm group label: Control arm
arm group type: No Intervention
description: No intervention in this group. Routine perioperative care.
intervention type: Drug
intervention name: Phenazopyridine
description: to be given preoperatively
arm group label: Pyridium arm
other name: Pyridium
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Charles Ascher-Walsh, M.D.
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Annacecilia Peacher
investigator title: Associate Professor
mesh term: Urinary Retention
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 