<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/NCT02216253</url>
  </required_header>
  <id_info>
    <org_study_id>UTI 2014</org_study_id>
    <nct_id>NCT02216253</nct_id>
  </id_info>
  <brief_title>L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection.</brief_title>
  <official_title>L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection: a Double-blind Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS San Raffaele</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS San Raffaele</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will include women who will undergo pelvic reconstructive surgery and/or&#xD;
      anti-incontinence sling procedures. Patients will be randomized to the combination of&#xD;
      L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract in tablet or placebo twice a day&#xD;
      during the seven days before and after surgery (total of 14 days). In this randomized,&#xD;
      double-blind study, the investigators will assess treatment of clinically suspected or&#xD;
      culture-proven urinary tract infections within 3 weeks of surgery (primary outcome), and risk&#xD;
      factors for treatment for postoperative urinary tract infections (secondary outcomes) between&#xD;
      the two study groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <primary_completion_date type="Actual">August 2015</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment for urinary tract infection after surgery.</measure>
    <time_frame>3 weeks after surgery.</time_frame>
    <description>To assess any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Urinary Tract Infection</condition>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The combination of L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract will be administered in tablet twice a day 7 days before and after surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo tablet twice a day 7 days before and after surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract</intervention_name>
    <description>L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract tablet twice a day 7 days before and after surgery</description>
    <arm_group_label>L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo tablet twice a day 7 days before and after surgery</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  postoperative transurethral catheterization after surgery for pelvic organ prolapse&#xD;
             and/or urinary incontinence&#xD;
&#xD;
          -  patients aged ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute urinary tract infection at the moment of inclusion in the study&#xD;
&#xD;
          -  antibiotic treatment prescribed for any other cause than urinary tract infection&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  known allergy to one of the elements of the active compound&#xD;
&#xD;
          -  surgery for mesh excision&#xD;
&#xD;
          -  surgery for urethral diverticulum&#xD;
&#xD;
          -  surgery for fistula repair&#xD;
&#xD;
          -  surgery for sacral neuromodulation&#xD;
&#xD;
          -  any condition precluding the acquisition of written consent&#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>Umberto Leone Roberti Maggiore, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stefano Salvatore, MD</last_name>
    <role>Study Director</role>
    <affiliation>IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University</name>
      <address>
        <city>Milan</city>
        <state>Lombardy</state>
        <zip>20100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 9, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 24, 2015</last_update_submitted>
  <last_update_submitted_qc>August 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS San Raffaele</investigator_affiliation>
    <investigator_full_name>Umberto Leone Roberti Maggiore</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Urinary tract infection</keyword>
  <keyword>Pelvic organ prolapse</keyword>
  <keyword>Urinary incontinence</keyword>
  <keyword>Stress urinary incontinence</keyword>
  <keyword>Mixed Urinary incontinence</keyword>
  <keyword>L-methionine</keyword>
  <keyword>Placebo</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Urinary Tract Infections</mesh_term>
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02216253
org study id: UTI 2014
nct id: NCT02216253
lead sponsor: 
has dmc: Yes
This study will include women who will undergo pelvic reconstructive surgery and/or
      anti-incontinence sling procedures. Patients will be randomized to the combination of
      L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract in tablet or placebo twice a day
      during the seven days before and after surgery (total of 14 days). In this randomized,
      double-blind study, the investigators will assess treatment of clinically suspected or
      culture-proven urinary tract infections within 3 weeks of surgery (primary outcome), and risk
      factors for treatment for postoperative urinary tract infections (secondary outcomes) between
      the two study groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Treatment for urinary tract infection after surgery.
time frame: 3 weeks after surgery.
description: To assess any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery.
arm group label: L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract
arm group type: Active Comparator
description: The combination of L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract will be administered in tablet twice a day 7 days before and after surgery
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo tablet twice a day 7 days before and after surgery
intervention type: Drug
intervention name: L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract
description: L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract tablet twice a day 7 days before and after surgery
arm group label: L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract
intervention type: Other
intervention name: Placebo
description: Placebo tablet twice a day 7 days before and after surgery
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Umberto Leone Roberti Maggiore, MD
role: Principal Investigator
affiliation: IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University
last name: Stefano Salvatore, MD
role: Study Director
affiliation: IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS San Raffaele
investigator full name: Umberto Leone Roberti Maggiore
investigator title: MD
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Urinary Tract Infections
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse