<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/NCT03818321</url>
  </required_header>
  <id_info>
    <org_study_id>18-115</org_study_id>
    <nct_id>NCT03818321</nct_id>
  </id_info>
  <brief_title>Urinary Track Infection Prevention After Urogynecological Surgery</brief_title>
  <official_title>Methenamine Hippurate With Cranberry Capsules Versus Cranberry Capsules Alone for UTI Prevention in a Short-term Indwelling Foley Catheter Population After Urogynecological Surgery: A Double-Blinded 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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is randomized double-blinded placebo-controlled trial to access oral Methenamine&#xD;
      Hippurate (MH) in combination with cranberry capsules is superior to cranberry capsules alone&#xD;
      in prevention of UTI in patients with transient post-operative urinary retention requiring a&#xD;
      Foley catheter after pelvic reconstructive surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Urinary tract infections (UTIs) are one of the most common bacterial infections in women. It&#xD;
      is estimated that 1.6 billion dollars are spent on UTI treatment each year. Antibiotics have&#xD;
      been the mainstay of treatment of UTIs, however frequent use has increased the prevalence of&#xD;
      antibiotic resistant organisms. Therefore, focus has shifted to non-antibiotic therapy for&#xD;
      UTI prophylaxis.&#xD;
&#xD;
      Methenamine Hippurate (MH) has been studied for decades due to its potential role in&#xD;
      prevention of UTI. While not technically an antibiotic, MH works via its bacteriostatic&#xD;
      action in the bladder. Benefits of MH are the lack of development of resistance, and the&#xD;
      selective nature of this drug to the urinary system only. However, MH is best used in&#xD;
      conjunction with an acidifying agent to increase its bioavailability (such as cranberry&#xD;
      capsules or other acidic products). The usage of MH has been studied in various populations,&#xD;
      has been seen to be effective in short-term catheterization. Usage of cranberry as&#xD;
      prophylaxis for UTI is controversial; however, results have been favorable in the&#xD;
      post-operative gynecological population.&#xD;
&#xD;
      Post-operative urinary retention (POUR) occurs frequently in patients who undergo&#xD;
      incontinence and pelvic prolapse surgery. Although the definition of POUR can vary between&#xD;
      clinicians, it is reported as 2.5-24% to as high as 43% after tension-free transvaginal mesh&#xD;
      sling placement. This population is at also at high risk for UTI due to advanced age and&#xD;
      menopausal status. Moreover, using a catheter longer than 2 days incurs a 2-fold increased&#xD;
      risk of development of UTI with an estimated 5% increase in bacteriuria each day of&#xD;
      catheterization.&#xD;
&#xD;
      In hopes to decrease the overuse of antibiotics and decrease the likelihood of antibiotic&#xD;
      resistance, we propose that the use of MH and cranberry can reflect a potential benefit in&#xD;
      this population of short-term indwelling Foley catheter use and help reduce the incidence of&#xD;
      post-operative UTI after pelvic surgery.&#xD;
&#xD;
      The patients will then be randomized to either receive cranberry capsules and placebo OR&#xD;
      cranberry capsules and Methenamine Hippurate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 17, 2019</start_date>
  <completion_date type="Actual">July 1, 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 2021</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>This is randomized double-blinded placebo-controlled trial, and both patients and investigators are blinded. However, a research nurse will not be blinded to the group allocation, and the research nurse will order each patient's medication to the inpatient pharmacy based on the study randomization scheme.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Urinary Track Infection (UTI)</measure>
    <time_frame>From surgery to one week post-op visit, approximately 1 week post surgery</time_frame>
    <description>Incidence of UTIs will be diagnosed at one week post-op visit.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">185</enrollment>
  <condition>Urinary Tract Infections</condition>
  <condition>Urinary Retention Postoperative</condition>
  <condition>Pelvic Organ Prolapse</condition>
  <arm_group>
    <arm_group_label>Methenamine Hippurate with Cranberry</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be instructed to take Methenamine Hippurate 1 g tablet ( 1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo with Cranberry</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will be instructed to take Placebo tablet (1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days.&#xD;
Cranberry capsules were incorporated into the standard practice of Cincinnati Urogynecology Associates, TriHealth Inc in mid-March 2016.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methenamine Hippurate 1 g tablet</intervention_name>
    <description>Methenamine Hippurate (study drug) is an FDA approved medication in the prevention of UTI. Methenamine Hippurate 1g contains Hippuric acid salt of Methenamine (hexamethylene tetramine), Magnesium Stearate, Povidone, Saccharin Sodium, FD&amp;C Yellow No. 5 (tartrazine) (www.iodine.com/drug/hiprex/fda-package-insert).</description>
    <arm_group_label>Methenamine Hippurate with Cranberry</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo tablet</intervention_name>
    <description>Placebo is a tablet that will be provided to you that looks like the study drug but does not contain any medication. These pills are comprised of gelatin and minimal amounts of lactose powder. The pills are designed to have no effect on the patient.</description>
    <arm_group_label>Placebo with Cranberry</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who undergo major pelvic organ prolapse surgery that are diagnosed with POUR&#xD;
             via failed retrograde void trial and require an indwelling Foley catheter upon&#xD;
             hospital discharge.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwillingness to participate in the study&#xD;
&#xD;
          -  Inability to understand English&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patient personal history of nephrolithiasis, urogenital anomaly, neurogenic bladder,&#xD;
             chronic renal insufficiency (GFR &lt;60 ml/min/1.73 m² or serum creatinine level &gt;1.03&#xD;
             for &gt;3months), sarcoidosis, and severe hepatic insufficiency&#xD;
&#xD;
          -  Currently (prior 3 months) undergoing medical management for recurrent UTI or&#xD;
             interstitial cystitis&#xD;
&#xD;
          -  Active urinary tract infection&#xD;
&#xD;
          -  Patient history of taking Warfarin (Coumadin)&#xD;
&#xD;
          -  Intraoperative bladder injury or cystotomy&#xD;
&#xD;
          -  Physical or mental impairment that would affect the subject's ability to take&#xD;
             medications daily or fill out questionnaires&#xD;
&#xD;
          -  Reported allergy to any of the ingredients in the cranberry, MH, or placebo pill&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</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>October 2022</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <results_first_submitted>October 19, 2022</results_first_submitted>
  <results_first_submitted_qc>October 19, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 14, 2022</results_first_posted>
  <last_update_submitted>October 19, 2022</last_update_submitted>
  <last_update_submitted_qc>October 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</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>Infections</mesh_term>
    <mesh_term>Urinary Tract Infections</mesh_term>
    <mesh_term>Urinary Retention</mesh_term>
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methenamine</mesh_term>
    <mesh_term>Methenamine hippurate</mesh_term>
    <mesh_term>Methenamine mandelate</mesh_term>
  </intervention_browse>
  <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>February 20, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT03818321/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Methenamine Hippurate With Cranberry</title>
          <description>Subjects will be instructed to take Methenamine Hippurate 1 g tablet ( 1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days.&#xD;
Methenamine Hippurate 1 g tablet: Methenamine Hippurate (study drug) is an FDA approved medication in the prevention of UTI. Methenamine Hippurate 1g contains Hippuric acid salt of Methenamine (hexamethylene tetramine), Magnesium Stearate, Povidone, Saccharin Sodium, FD&amp;C Yellow No. 5 (tartrazine) (www.iodine.com/drug/hiprex/fda-package-insert).</description>
        </group>
        <group group_id="P2">
          <title>Placebo With Cranberry</title>
          <description>Subjects will be instructed to take Placebo tablet (1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days.&#xD;
Cranberry capsules were incorporated into the standard practice of Cincinnati Urogynecology Associates, TriHealth Inc in mid-March 2016.&#xD;
Placebo tablet: Placebo is a tablet that will be provided to you that looks like the study drug but does not contain any medication. These pills are comprised of gelatin and minimal amounts of lactose powder. The pills are designed to have no effect on the patient.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="94"/>
                <participants group_id="P2" count="91"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
                <participants group_id="P2" count="89"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </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="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Methenamine Hippurate With Cranberry</title>
          <description>Subjects will be instructed to take Methenamine Hippurate 1 g tablet ( 1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days.&#xD;
Methenamine Hippurate 1 g tablet: Methenamine Hippurate (study drug) is an FDA approved medication in the prevention of UTI. Methenamine Hippurate 1g contains Hippuric acid salt of Methenamine (hexamethylene tetramine), Magnesium Stearate, Povidone, Saccharin Sodium, FD&amp;C Yellow No. 5 (tartrazine) (www.iodine.com/drug/hiprex/fda-package-insert).</description>
        </group>
        <group group_id="B2">
          <title>Placebo With Cranberry</title>
          <description>Subjects will be instructed to take Placebo tablet (1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days.&#xD;
Cranberry capsules were incorporated into the standard practice of Cincinnati Urogynecology Associates, TriHealth Inc in mid-March 2016.&#xD;
Placebo tablet: Placebo is a tablet that will be provided to you that looks like the study drug but does not contain any medication. These pills are comprised of gelatin and minimal amounts of lactose powder. The pills are designed to have no effect on the patient.</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="93"/>
            <count group_id="B2" value="89"/>
            <count group_id="B3" value="182"/>
          </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="61.27" spread="12.86"/>
                    <measurement group_id="B2" value="60.61" spread="12.44"/>
                    <measurement group_id="B3" value="60.95" spread="12.63"/>
                  </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="93"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="182"/>
                  </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>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <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="93"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Urinary Track Infection (UTI)</title>
        <description>Incidence of UTIs will be diagnosed at one week post-op visit.</description>
        <time_frame>From surgery to one week post-op visit, approximately 1 week post surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methenamine Hippurate With Cranberry</title>
            <description>Subjects will be instructed to take Methenamine Hippurate 1 g tablet ( 1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days.&#xD;
Methenamine Hippurate 1 g tablet: Methenamine Hippurate (study drug) is an FDA approved medication in the prevention of UTI. Methenamine Hippurate 1g contains Hippuric acid salt of Methenamine (hexamethylene tetramine), Magnesium Stearate, Povidone, Saccharin Sodium, FD&amp;C Yellow No. 5 (tartrazine) (www.iodine.com/drug/hiprex/fda-package-insert).</description>
          </group>
          <group group_id="O2">
            <title>Placebo With Cranberry</title>
            <description>Subjects will be instructed to take Placebo tablet (1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days.&#xD;
Cranberry capsules were incorporated into the standard practice of Cincinnati Urogynecology Associates, TriHealth Inc in mid-March 2016.&#xD;
Placebo tablet: Placebo is a tablet that will be provided to you that looks like the study drug but does not contain any medication. These pills are comprised of gelatin and minimal amounts of lactose powder. The pills are designed to have no effect on the patient.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Urinary Track Infection (UTI)</title>
          <description>Incidence of UTIs will be diagnosed at one week post-op visit.</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="93"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 week postop</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Methenamine Hippurate With Cranberry</title>
          <description>Subjects will be instructed to take Methenamine Hippurate 1 g tablet ( 1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days.&#xD;
Methenamine Hippurate 1 g tablet: Methenamine Hippurate (study drug) is an FDA approved medication in the prevention of UTI. Methenamine Hippurate 1g contains Hippuric acid salt of Methenamine (hexamethylene tetramine), Magnesium Stearate, Povidone, Saccharin Sodium, FD&amp;C Yellow No. 5 (tartrazine) (www.iodine.com/drug/hiprex/fda-package-insert).</description>
        </group>
        <group group_id="E2">
          <title>Placebo With Cranberry</title>
          <description>Subjects will be instructed to take Placebo tablet (1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days.&#xD;
Cranberry capsules were incorporated into the standard practice of Cincinnati Urogynecology Associates, TriHealth Inc in mid-March 2016.&#xD;
Placebo tablet: Placebo is a tablet that will be provided to you that looks like the study drug but does not contain any medication. These pills are comprised of gelatin and minimal amounts of lactose powder. The pills are designed to have no effect on the patient.</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="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
              </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="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
              </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>Dr. Rachel Pauls</name_or_title>
      <organization>TriHealth</organization>
      <phone>513-463-4300</phone>
      <email>Rachel_Pauls@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/NCT03818321
org study id: 18-115
nct id: NCT03818321
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study is randomized double-blinded placebo-controlled trial to access oral Methenamine
      Hippurate (MH) in combination with cranberry capsules is superior to cranberry capsules alone
      in prevention of UTI in patients with transient post-operative urinary retention requiring a
      Foley catheter after pelvic reconstructive surgery.
Urinary tract infections (UTIs) are one of the most common bacterial infections in women. It
      is estimated that 1.6 billion dollars are spent on UTI treatment each year. Antibiotics have
      been the mainstay of treatment of UTIs, however frequent use has increased the prevalence of
      antibiotic resistant organisms. Therefore, focus has shifted to non-antibiotic therapy for
      UTI prophylaxis.

      Methenamine Hippurate (MH) has been studied for decades due to its potential role in
      prevention of UTI. While not technically an antibiotic, MH works via its bacteriostatic
      action in the bladder. Benefits of MH are the lack of development of resistance, and the
      selective nature of this drug to the urinary system only. However, MH is best used in
      conjunction with an acidifying agent to increase its bioavailability (such as cranberry
      capsules or other acidic products). The usage of MH has been studied in various populations,
      has been seen to be effective in short-term catheterization. Usage of cranberry as
      prophylaxis for UTI is controversial; however, results have been favorable in the
      post-operative gynecological population.

      Post-operative urinary retention (POUR) occurs frequently in patients who undergo
      incontinence and pelvic prolapse surgery. Although the definition of POUR can vary between
      clinicians, it is reported as 2.5-24% to as high as 43% after tension-free transvaginal mesh
      sling placement. This population is at also at high risk for UTI due to advanced age and
      menopausal status. Moreover, using a catheter longer than 2 days incurs a 2-fold increased
      risk of development of UTI with an estimated 5% increase in bacteriuria each day of
      catheterization.

      In hopes to decrease the overuse of antibiotics and decrease the likelihood of antibiotic
      resistance, we propose that the use of MH and cranberry can reflect a potential benefit in
      this population of short-term indwelling Foley catheter use and help reduce the incidence of
      post-operative UTI after pelvic surgery.

      The patients will then be randomized to either receive cranberry capsules and placebo OR
      cranberry capsules and Methenamine Hippurate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: This is randomized double-blinded placebo-controlled trial, and both patients and investigators are blinded. However, a research nurse will not be blinded to the group allocation, and the research nurse will order each patient's medication to the inpatient pharmacy based on the study randomization scheme.
measure: Incidence of Urinary Track Infection (UTI)
time frame: From surgery to one week post-op visit, approximately 1 week post surgery
description: Incidence of UTIs will be diagnosed at one week post-op visit.
arm group label: Methenamine Hippurate with Cranberry
arm group type: Experimental
description: Subjects will be instructed to take Methenamine Hippurate 1 g tablet ( 1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days.
arm group label: Placebo with Cranberry
arm group type: Placebo Comparator
description: Subjects will be instructed to take Placebo tablet (1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days.
Cranberry capsules were incorporated into the standard practice of Cincinnati Urogynecology Associates, TriHealth Inc in mid-March 2016.
intervention type: Drug
intervention name: Methenamine Hippurate 1 g tablet
description: Methenamine Hippurate (study drug) is an FDA approved medication in the prevention of UTI. Methenamine Hippurate 1g contains Hippuric acid salt of Methenamine (hexamethylene tetramine), Magnesium Stearate, Povidone, Saccharin Sodium, FD&C Yellow No. 5 (tartrazine) (www.iodine.com/drug/hiprex/fda-package-insert).
arm group label: Methenamine Hippurate with Cranberry
intervention type: Drug
intervention name: Placebo tablet
description: Placebo is a tablet that will be provided to you that looks like the study drug but does not contain any medication. These pills are comprised of gelatin and minimal amounts of lactose powder. The pills are designed to have no effect on the patient.
arm group label: Placebo with Cranberry
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
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: Infections
mesh term: Urinary Tract Infections
mesh term: Urinary Retention
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
mesh term: Methenamine
mesh term: Methenamine hippurate
mesh term: Methenamine mandelate
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 