<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/NCT04479709</url>
  </required_header>
  <id_info>
    <org_study_id>IRB20-00120</org_study_id>
    <nct_id>NCT04479709</nct_id>
  </id_info>
  <brief_title>The Urinary Microbiome in Patients Receiving Intradetrusor Botox Injections</brief_title>
  <official_title>The Urinary Microbiome Before and After Treatment With Intradetrusor Onabotulinum Toxin A Injection for Overactive Bladder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MetroHealth Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MetroHealth Medical Center</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>
      An altered urinary microbiome (UM) may explain the symptoms in overactive bladder (OAB)&#xD;
      patients who were previously considered to have &quot;idiopathic&quot; OAB. To date, most research on&#xD;
      the relationship between OAB and the UM has focused on differentiating between the UM of a&#xD;
      normal bladder and that of an OAB bladder. There is currently a paucity of data on the way&#xD;
      that OAB therapy impacts the UM. One of the few studies to evaluate the UM pre- and post-OAB&#xD;
      treatment focused on how management with solifenacin affected the UM, but no studies have&#xD;
      evaluated how intravesical onabotulinumtoxin A injections (IOI) affects the UM. Understanding&#xD;
      IOI's impact on the UM is particularly interesting because despite both anticholinergics and&#xD;
      IOI exerting antimuscarinic affects on the bladder, IOI is often successful when&#xD;
      anticholinergics are not. This raises the question of what other mechanisms of action IOI may&#xD;
      have in the bladders of OAB patients - one hypothesis is that it might stabilize the UM in&#xD;
      those select patients who suffer from OAB due to an altered UM. The primary objective of this&#xD;
      study is therefore to determine the UM profiles of OAB patients before and after treatment&#xD;
      with IOI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>4 Weeks</target_duration>
  <primary_outcome>
    <measure>Urinary Microbiome</measure>
    <time_frame>08/2020 - 08/2021</time_frame>
    <description>To evaluate whether administration of intradetrusor botox injections for the treatment of overactive bladder results in changes to the urinary microbiome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urinary Microbiome by response</measure>
    <time_frame>08/2020 - 08/2021</time_frame>
    <description>To evaluate whether there are differences between responders and non-responders to intradetrusor botox injections in the pre- and post-treatment urinary microbiomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary tract infection</measure>
    <time_frame>08/2020 - 08/2021</time_frame>
    <description>Determine if there is a relationship between pre- or post-intradetrusor botox injection and the rate of urinary tract infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>08/2020 - 08/2021</time_frame>
    <description>Adverse events from intradetrusor botox injection</description>
  </secondary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Overactive Bladder</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Women undergoing intradetrusor botox injection with botox 100 U&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Women undergoing intradetrusor botox injection with botox 100 U&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current UTI&#xD;
&#xD;
          -  History of recurrent UTI&#xD;
&#xD;
          -  History of antibiotic exposure for any reason (including if response is &quot;unknown&quot;)&#xD;
&#xD;
          -  Antibiotic exposure for any reason other than post-procedure prophylaxis during the&#xD;
             four-week follow-up period.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>MetroHealth</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>September 16, 2022</last_update_submitted>
  <last_update_submitted_qc>September 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>MetroHealth Medical Center</investigator_affiliation>
    <investigator_full_name>Jeffrey Mangel</investigator_full_name>
    <investigator_title>Associate Professor, Case Western Reserve University School of Medicine</investigator_title>
  </responsible_party>
  <keyword>Overactive bladder</keyword>
  <keyword>Urinary microbiome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04479709
org study id: IRB20-00120
nct id: NCT04479709
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An altered urinary microbiome (UM) may explain the symptoms in overactive bladder (OAB)
      patients who were previously considered to have "idiopathic" OAB. To date, most research on
      the relationship between OAB and the UM has focused on differentiating between the UM of a
      normal bladder and that of an OAB bladder. There is currently a paucity of data on the way
      that OAB therapy impacts the UM. One of the few studies to evaluate the UM pre- and post-OAB
      treatment focused on how management with solifenacin affected the UM, but no studies have
      evaluated how intravesical onabotulinumtoxin A injections (IOI) affects the UM. Understanding
      IOI's impact on the UM is particularly interesting because despite both anticholinergics and
      IOI exerting antimuscarinic affects on the bladder, IOI is often successful when
      anticholinergics are not. This raises the question of what other mechanisms of action IOI may
      have in the bladders of OAB patients - one hypothesis is that it might stabilize the UM in
      those select patients who suffer from OAB due to an altered UM. The primary objective of this
      study is therefore to determine the UM profiles of OAB patients before and after treatment
      with IOI.
observational model: Cohort
time perspective: Prospective
measure: Urinary Microbiome
time frame: 08/2020 - 08/2021
description: To evaluate whether administration of intradetrusor botox injections for the treatment of overactive bladder results in changes to the urinary microbiome.
measure: Urinary Microbiome by response
time frame: 08/2020 - 08/2021
description: To evaluate whether there are differences between responders and non-responders to intradetrusor botox injections in the pre- and post-treatment urinary microbiomes.
measure: Urinary tract infection
time frame: 08/2020 - 08/2021
description: Determine if there is a relationship between pre- or post-intradetrusor botox injection and the rate of urinary tract infection.
measure: Adverse events
time frame: 08/2020 - 08/2021
description: Adverse events from intradetrusor botox injection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 89 Years
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: MetroHealth Medical Center
investigator full name: Jeffrey Mangel
investigator title: Associate Professor, Case Western Reserve University School of Medicine
mesh term: Urinary Bladder, Overactive
sharing ipd: Undecided