<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/NCT03790254</url>
  </required_header>
  <id_info>
    <org_study_id>ReviewUTIs</org_study_id>
    <nct_id>NCT03790254</nct_id>
  </id_info>
  <brief_title>D Mannose for Prevention and Treatment of RUTIs</brief_title>
  <acronym>mannoseRUTIs</acronym>
  <official_title>Oral D Mannose in the Prevention and Treatment of Recurrent Urinary Tract Infections: a Systematic Review</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Policlinico S. Matteo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Policlinico S. Matteo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this review is to address clinical reliability, efficacy and safety of long-term&#xD;
      treatment with oral D Mannose for the prevention of recurrent urinary tract infections&#xD;
      (RUTIs) in females.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A comprehensive systematic MEDLINE, Embase, Cochrane search was performed for English&#xD;
      language reports published before December 2018 using the term &quot;recurrent urinary tract&#xD;
      infections and d mannose.&quot; We searched Medline, Embase, and the Cochrane Register of&#xD;
      Controlled Trials since January 2010 to December 2018. Eligible studies did not include&#xD;
      non-oral therapy, local (vaginal) treatment in women with RUTIs.&#xD;
&#xD;
      Study eligibility criteria- We identified eligible original articles. The heterogeneity of&#xD;
      the available studies, their different rationale and aim, the assumption of d mannose for&#xD;
      prophylaxis or treatment of recurrent UTIs need to be taken into account.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2010</start_date>
  <completion_date type="Actual">December 25, 2018</completion_date>
  <primary_completion_date type="Actual">December 20, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>research literature data on d mannose for prevention and treatment of recurrent urinary tract infections.</measure>
    <time_frame>January 2010-December 2018</time_frame>
    <description>literature search of the Medline, Embase, and Cochrane Library databases</description>
  </primary_outcome>
  <enrollment type="Actual">500</enrollment>
  <condition>Recurrent Urinary Tract Infections</condition>
  <condition>Antibiotic Prophylaxis</condition>
  <condition>Antibiotic Resistance</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>systematic review</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Search strategy and selection criteria Only publications with the text and/or the abstract&#xD;
        written in the English language were considered. Additional papers cited in the references&#xD;
        of the search manuscripts were further examined. Articles not addressing topics of interest&#xD;
        were excluded, and the full text of the remaining articles was examined. Our literature&#xD;
        search identified 15 articles pertaining to the search terms (Word variations have been&#xD;
        searched). Further analysis of these articles resulted in 11 clinical trials which were&#xD;
        deemed relevant to our review. The retrieved studies were assessed for their relevance&#xD;
        based on the title and abstracts. Finally, studies references were screened in order to&#xD;
        identify eventually unknown studies.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        recurrent urinary tract infections (RUTIs)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Upper urinary tract infections, severe clinical symptoms, fever &gt; 37,5 with lumbar pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniele Porru, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione IRCCS Policlinico San Matteo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Urology Department Fondazione IRCCS Policlinico San Matteo</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>December 28, 2018</last_update_submitted>
  <last_update_submitted_qc>December 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Policlinico S. Matteo</investigator_affiliation>
    <investigator_full_name>Daniele Porru</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>recurrent urinary tract infections</keyword>
  <keyword>d mannose prophylaxis</keyword>
  <keyword>antibiotic prophylaxis</keyword>
  <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>Recurrence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03790254
org study id: ReviewUTIs
nct id: NCT03790254
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this review is to address clinical reliability, efficacy and safety of long-term
      treatment with oral D Mannose for the prevention of recurrent urinary tract infections
      (RUTIs) in females.
A comprehensive systematic MEDLINE, Embase, Cochrane search was performed for English
      language reports published before December 2018 using the term "recurrent urinary tract
      infections and d mannose." We searched Medline, Embase, and the Cochrane Register of
      Controlled Trials since January 2010 to December 2018. Eligible studies did not include
      non-oral therapy, local (vaginal) treatment in women with RUTIs.

      Study eligibility criteria- We identified eligible original articles. The heterogeneity of
      the available studies, their different rationale and aim, the assumption of d mannose for
      prophylaxis or treatment of recurrent UTIs need to be taken into account.
observational model: Other
time perspective: Retrospective
measure: research literature data on d mannose for prevention and treatment of recurrent urinary tract infections.
time frame: January 2010-December 2018
description: literature search of the Medline, Embase, and Cochrane Library databases
intervention type: Other
intervention name: systematic review
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Daniele Porru, MD
role: Principal Investigator
affiliation: Fondazione IRCCS Policlinico San Matteo
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Policlinico S. Matteo
investigator full name: Daniele Porru
investigator title: MD
mesh term: Infections
mesh term: Urinary Tract Infections
mesh term: Recurrence
sharing ipd: No