<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/NCT04444440</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00101838</org_study_id>
    <nct_id>NCT04444440</nct_id>
  </id_info>
  <brief_title>Antibiotic Prophylaxis for Bladder Botox</brief_title>
  <official_title>Prophylactic Antibiotics During Treatment of Idiopathic Overactive Bladder With Intradetrusor onabotulinumtoxinA for the Reduction of Postoperative UTI: a Randomized Blinded Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Women and Children's Health Research Institute, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Injection of Botox into the bladder is a common treatment for overactive bladder.&#xD;
      Postoperative bladder infection is one of the more frequently reported complications of this&#xD;
      procedure. Prophylactic antibiotics given at the time of bladder Botox for the reduction of&#xD;
      postoperative bladder infection have not been well studied. The main goal of our study is to&#xD;
      determine if prophylactic antibiotics at the time of bladder Botox injection for the&#xD;
      treatment of overactive bladder in women reduces postoperative bladder infection. The&#xD;
      investigators are proposing a study which will randomize participants into two groups - one&#xD;
      receiving Ciprofloxacin and the other receiving placebo pills for three days following the&#xD;
      procedure. The primary outcome evaluated will be the difference in postoperative bladder&#xD;
      infection between the two groups. The investigators will also investigate differences in&#xD;
      reported side effects between the two groups possibly related to antibiotic use. Follow-up&#xD;
      will be over six weeks following the procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a single-centred, double-blinded, randomized, placebo-controlled trial.&#xD;
      Recruitment will be undertaken at two Urogynecology/Urology sites associated with the&#xD;
      University of Alberta in Edmonton, Alberta. Participants will be randomized to treatment or&#xD;
      placebo arm with a 1:1 allocation ratio. Patients and surgeons will be blinded.&#xD;
&#xD;
      On the day of the procedure, a urine culture will be collected preoperatively to identify&#xD;
      pre-existing bacteriuria. Technique and dose of Botox injection will be at the discretion of&#xD;
      the operating physician. Trigone-sparing technique with injection of 100 to 200 units of&#xD;
      Botox distributed across 10 to 20 sites is generally used at our centre.&#xD;
&#xD;
      Follow-up will occur over a six-week postoperative period. A questionnaire will be used at&#xD;
      each follow-up encounter to screen patients for urinary tract infection symptoms, voiding&#xD;
      dysfunction, and other adverse events potentially related to the prophylactic antibiotics.&#xD;
      Urine cultures will be collected to confirm infection for patients developing postoperative&#xD;
      symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 6, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <intervention_model_description>Patients will be randomized at a 1:1 allocation ratio to two parallel treatment arms - intervention versus placebo</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Placebo</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Postoperative Urinary Tract Infection</measure>
    <time_frame>2 weeks following the procedure</time_frame>
    <description>new or worsening symptoms (dysuria, hematuria, frequency, urgency, suprapubic/flank pain, fever) AND positive urine culture (&gt;10^5 CFU/mL)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Postoperative Urinary Tract Infection Rate</measure>
    <time_frame>1 and 6 weeks following the procedure</time_frame>
    <description>new or worsening symptoms (dysuria, hematuria, frequency, urgency, suprapubic/flank pain, fever) AND positive urine culture (&gt;10^5 CFU/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Other Adverse Events</measure>
    <time_frame>1, 2 and 6 weeks following the procedure</time_frame>
    <description>New onset of side effects possibly related to Ciprofloxacin (nausea/vomiting, headache, abdominal pain, constipation, diarrhea, other)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">202</enrollment>
  <condition>Idiopathic Overactive Bladder</condition>
  <condition>Postoperative Urinary Tract Infection</condition>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ciprofloxacin 500 mg PO every 12 hrs for 3 days following the procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo pill PO every 12 hrs for 3 days following the procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ciprofloxacin</intervention_name>
    <description>Fluoroquinolone antibiotic.</description>
    <arm_group_label>Treatment Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo Pill</intervention_name>
    <description>Placebo Pill</description>
    <arm_group_label>Placebo Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with idiopathic OAB diagnosed clinically who have failed medical management&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with neurogenic OAB (OAB with potential underlying neurologic cause -&#xD;
             multiple sclerosis, spinal cord injury, Parkinson's disease, other)&#xD;
&#xD;
          -  Contraindication to injection of Botox - hypersensitivity to any botulinum toxin&#xD;
             preparation or to any of the components in the formulation, current urinary tract&#xD;
             infection, symptomatic urinary retention or PVR &gt; 200 mL, unwillingness or inability&#xD;
             to initiate CIC post-treatment if required.&#xD;
&#xD;
          -  Contraindication to oral Ciprofloxacin - hypersensitivity or allergy to Ciprofloxacin&#xD;
             or other fluoroquinolone, concurrently taking Tizanidine or Agomelatine.14&#xD;
&#xD;
          -  Active antibiotic therapy for any indication at the time of Botox injection -&#xD;
             increased risk of adverse reaction with combining antibiotics, reduced risk of UTI&#xD;
             with additional antibiotic.&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Age &lt; 18&#xD;
&#xD;
          -  Pregnant and/or breastfeeding&#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_contact>
    <last_name>Erin Kelly, MD FRCSC</last_name>
    <phone>780-735-5290</phone>
    <email>eckelly@ualberta.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jane Schulz, MR FRCSC</last_name>
    <phone>780-970-4659</phone>
    <email>schulz@ualberta.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Urogynecology Clinic - Royal Alexandra Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5H3V9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erin Kelly, MD FRCSC</last_name>
      <phone>7807355290</phone>
      <email>eckelly@ualberta.ca</email>
    </contact>
    <contact_backup>
      <last_name>Paul Groves, MD FRCSC</last_name>
      <phone>7809991561</phone>
      <email>pgroves@ualberta.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Erin Kelly, MD FRCSC</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jane Schulz, MD FRCSC</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paul Groves, MD FRCSC</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prophylaxis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Tract Infections</mesh_term>
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ciprofloxacin</mesh_term>
  </intervention_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/NCT04444440
org study id: Pro00101838
nct id: NCT04444440
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Injection of Botox into the bladder is a common treatment for overactive bladder.
      Postoperative bladder infection is one of the more frequently reported complications of this
      procedure. Prophylactic antibiotics given at the time of bladder Botox for the reduction of
      postoperative bladder infection have not been well studied. The main goal of our study is to
      determine if prophylactic antibiotics at the time of bladder Botox injection for the
      treatment of overactive bladder in women reduces postoperative bladder infection. The
      investigators are proposing a study which will randomize participants into two groups - one
      receiving Ciprofloxacin and the other receiving placebo pills for three days following the
      procedure. The primary outcome evaluated will be the difference in postoperative bladder
      infection between the two groups. The investigators will also investigate differences in
      reported side effects between the two groups possibly related to antibiotic use. Follow-up
      will be over six weeks following the procedure.
This study will be a single-centred, double-blinded, randomized, placebo-controlled trial.
      Recruitment will be undertaken at two Urogynecology/Urology sites associated with the
      University of Alberta in Edmonton, Alberta. Participants will be randomized to treatment or
      placebo arm with a 1:1 allocation ratio. Patients and surgeons will be blinded.

      On the day of the procedure, a urine culture will be collected preoperatively to identify
      pre-existing bacteriuria. Technique and dose of Botox injection will be at the discretion of
      the operating physician. Trigone-sparing technique with injection of 100 to 200 units of
      Botox distributed across 10 to 20 sites is generally used at our centre.

      Follow-up will occur over a six-week postoperative period. A questionnaire will be used at
      each follow-up encounter to screen patients for urinary tract infection symptoms, voiding
      dysfunction, and other adverse events potentially related to the prophylactic antibiotics.
      Urine cultures will be collected to confirm infection for patients developing postoperative
      symptoms.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized at a 1:1 allocation ratio to two parallel treatment arms - intervention versus placebo
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Placebo
measure: Rate of Postoperative Urinary Tract Infection
time frame: 2 weeks following the procedure
description: new or worsening symptoms (dysuria, hematuria, frequency, urgency, suprapubic/flank pain, fever) AND positive urine culture (>10^5 CFU/mL)
measure: Rate of Postoperative Urinary Tract Infection Rate
time frame: 1 and 6 weeks following the procedure
description: new or worsening symptoms (dysuria, hematuria, frequency, urgency, suprapubic/flank pain, fever) AND positive urine culture (>10^5 CFU/mL)
measure: Rate of Other Adverse Events
time frame: 1, 2 and 6 weeks following the procedure
description: New onset of side effects possibly related to Ciprofloxacin (nausea/vomiting, headache, abdominal pain, constipation, diarrhea, other)
arm group label: Treatment Arm
arm group type: Active Comparator
description: Ciprofloxacin 500 mg PO every 12 hrs for 3 days following the procedure
arm group label: Placebo Arm
arm group type: Placebo Comparator
description: Placebo pill PO every 12 hrs for 3 days following the procedure
intervention type: Drug
intervention name: Ciprofloxacin
description: Fluoroquinolone antibiotic.
arm group label: Treatment Arm
intervention type: Other
intervention name: Placebo Pill
description: Placebo Pill
arm group label: Placebo Arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Erin Kelly, MD FRCSC
phone: 780-735-5290
email: eckelly@ualberta.ca
last name: Jane Schulz, MR FRCSC
phone: 780-970-4659
email: schulz@ualberta.ca
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Urinary Tract Infections
mesh term: Urinary Bladder, Overactive
mesh term: Ciprofloxacin
sharing ipd: No