<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/NCT03755089</url>
  </required_header>
  <id_info>
    <org_study_id>1258364-2</org_study_id>
    <nct_id>NCT03755089</nct_id>
  </id_info>
  <brief_title>Oral vs Intravesical Analgesia for Office Bladder Botox Injections</brief_title>
  <acronym>OPIL</acronym>
  <official_title>Oral Phenazopyridine Versus Intravesical Lidocaine for Office OnabotulinumtoxinA Analgesia: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Women and Infants Hospital of Rhode Island</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Women and Infants Hospital of Rhode Island</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      OnabotulinumtoxinA (Botox®) bladder injections are a highly effective treatment for&#xD;
      overactive bladder and urgency urinary incontinence. The procedure is typically performed in&#xD;
      the office setting with one of two medications to control comfort. However, the effectiveness&#xD;
      of these medications has never been compared. The goal of this study is to determine which&#xD;
      medication is better at providing comfort during bladder Botox® injections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this randomized clinical trial is to compare the analgesic effect of oral&#xD;
      phenazopyridine to that of intravesical lidocaine during intradetrusor injections of&#xD;
      onabotulinumtoxinA performed for idiopathic overactive bladder. The investigators will&#xD;
      achieve this by measuring the mean visual-analog pain scores (VAS) in women who are&#xD;
      randomized to receive either oral phenazopyridine or intravesical lidocaine.&#xD;
&#xD;
      Secondary aims include assessment of:&#xD;
&#xD;
        1. Overall Patient Satisfaction: To compare overall patient satisfaction with the&#xD;
           onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral&#xD;
           phenazopyridine versus those randomized to intravesical lidocaine instillation.&#xD;
&#xD;
        2. Ease of Procedure: To compare the physician's perception of ease of onabotulinumtoxinA&#xD;
           injection procedure in women randomized to pre-procedure oral phenazopyridine versus&#xD;
           those randomized to intravesical lidocaine instillation.&#xD;
&#xD;
        3. Office Efficiency/Total Appointment Duration: To compare total appointment time or total&#xD;
           time spent in an office exam/procedure room in women randomized to pre-procedure oral&#xD;
           phenazopyridine versus those randomized to intravesical lidocaine instillation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">March 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Analgesic Effect Measured with 100mm Visual Analog Scale</measure>
    <time_frame>Immediately post-procedure</time_frame>
    <description>The visual analog scale is a visual representation of pain severity rated from 0 (no pain) to 10 (worst pain imaginable). Therefore higher numbers represent more pain.The scale is represented visually using a 100 millimeter line and patients indicate their level of pain by pointing to a location on the line.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Patient Satisfaction</measure>
    <time_frame>Immediately post-procedure</time_frame>
    <description>Overall patient satisfaction with the onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. Overall satisfaction will be measured with a single-item question utilizing a Likert scale with options ranging from very satisfied to very unsatisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of Procedure</measure>
    <time_frame>Immediately post-procedure</time_frame>
    <description>Physician's perception of ease of onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. This will be measured with a single item, five point Likert scale with options ranging from no difficulty to great difficulty.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Office Efficiency/Total Appointment Duration</measure>
    <time_frame>Immediately post-procedure</time_frame>
    <description>Total appointment time or total time spent in an office exam/procedure room in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. This will be measured by subtracting the appointment start time (time the patient was placed in the exam room) from the appointment end time (time of patient check-out).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Overactive Bladder Syndrome</condition>
  <condition>Urge Incontinence</condition>
  <condition>Urinary Incontinence</condition>
  <condition>Detrusor Hyperreflexia</condition>
  <condition>Detrusor Instability</condition>
  <arm_group>
    <arm_group_label>Oral Phenazopyridine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to the oral phenzopyridine arm will receive 200mg phenazopyridine to take by mouth 1-2 hours before their scheduled procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravesical Lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to the intravesical lidocaine arm will have the bladder back-filled with 30mL 2% lidocaine for the 20 minutes immediately preceding their procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phenazopyridine</intervention_name>
    <description>200mg PO Phenazopyridine taken 1-2 hours prior to the Botox® injection procedure</description>
    <arm_group_label>Oral Phenazopyridine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine 2% Injectable Solution</intervention_name>
    <description>30mL 2% lidocaine instilled into the bladder lumen 20 via a urinary catheter 20 minutes prior to the Botox® injection procedure</description>
    <arm_group_label>Intravesical Lidocaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-pregnant, adult females 18 years of age or older&#xD;
&#xD;
          -  Diagnosis of idiopathic overactive bladder&#xD;
&#xD;
          -  Planning office-based bladder injection of onabotulinumtoxinA&#xD;
&#xD;
          -  Willing and able to complete all study related items and interviews&#xD;
&#xD;
          -  Grossly neurologically normal on exam&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known neurologic diseases (multiple sclerosis, Parkinson Disease, CVA within 6 months,&#xD;
             myasthenia gravis, Charcot-Marie-Tooth disease, peripheral neuropathy, and complete&#xD;
             spinal cord injury) believed to affect urinary function&#xD;
&#xD;
          -  Planned injection of &gt;100 units of onabotulinumtoxinA&#xD;
&#xD;
          -  OnabotulinumtoxinA given for another indication within the previous 3 months (if&#xD;
             cumulative dose would total &gt;400 units)&#xD;
&#xD;
          -  Any intradetrusor onabotulinumtoxinA injections in the previous 12 months&#xD;
&#xD;
          -  Serum creatinine level greater than twice the upper limit of normal within the year&#xD;
             prior to enrollment&#xD;
&#xD;
          -  Allergy to lidocaine&#xD;
&#xD;
          -  Allergy to onabotulinumtoxinA&#xD;
&#xD;
          -  Allergy to phenazopyridine&#xD;
&#xD;
          -  Untreated urinary tract infection (UTI)&#xD;
&#xD;
          -  Currently pregnant or lactating.&#xD;
&#xD;
          -  Known urinary retention (post-void residual &gt;200mL) and inability to perform&#xD;
             intermittent self-catheterization&#xD;
&#xD;
          -  Uninvestigated hematuria (gross or microscopic)&#xD;
&#xD;
          -  Current or prior bladder malignancy&#xD;
&#xD;
          -  Previous bladder augmentation or surgically altered detrusor muscle&#xD;
&#xD;
          -  Prior pelvic radiation&#xD;
&#xD;
          -  Primary language other than English or Spanish&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lauren E Stewart, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Women and Infants Hospital of Rhode Island</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lauren E Stewart, MD</last_name>
    <phone>401-453-7560</phone>
    <phone_ext>48762</phone_ext>
    <email>lstewart@wihri.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Women &amp; Infants Hospital of Rhode Island</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lauren E Stewart, MD</last_name>
      <phone>401-453-7560</phone>
      <phone_ext>48762</phone_ext>
      <email>lstewart@wihri.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</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>Reflex, Abnormal</mesh_term>
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
    <mesh_term>Urinary Incontinence, Urge</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</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/NCT03755089
org study id: 1258364-2
nct id: NCT03755089
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
OnabotulinumtoxinA (Botox®) bladder injections are a highly effective treatment for
      overactive bladder and urgency urinary incontinence. The procedure is typically performed in
      the office setting with one of two medications to control comfort. However, the effectiveness
      of these medications has never been compared. The goal of this study is to determine which
      medication is better at providing comfort during bladder Botox® injections.
The primary aim of this randomized clinical trial is to compare the analgesic effect of oral
      phenazopyridine to that of intravesical lidocaine during intradetrusor injections of
      onabotulinumtoxinA performed for idiopathic overactive bladder. The investigators will
      achieve this by measuring the mean visual-analog pain scores (VAS) in women who are
      randomized to receive either oral phenazopyridine or intravesical lidocaine.

      Secondary aims include assessment of:

        1. Overall Patient Satisfaction: To compare overall patient satisfaction with the
           onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral
           phenazopyridine versus those randomized to intravesical lidocaine instillation.

        2. Ease of Procedure: To compare the physician's perception of ease of onabotulinumtoxinA
           injection procedure in women randomized to pre-procedure oral phenazopyridine versus
           those randomized to intravesical lidocaine instillation.

        3. Office Efficiency/Total Appointment Duration: To compare total appointment time or total
           time spent in an office exam/procedure room in women randomized to pre-procedure oral
           phenazopyridine versus those randomized to intravesical lidocaine instillation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Analgesic Effect Measured with 100mm Visual Analog Scale
time frame: Immediately post-procedure
description: The visual analog scale is a visual representation of pain severity rated from 0 (no pain) to 10 (worst pain imaginable). Therefore higher numbers represent more pain.The scale is represented visually using a 100 millimeter line and patients indicate their level of pain by pointing to a location on the line.
measure: Overall Patient Satisfaction
time frame: Immediately post-procedure
description: Overall patient satisfaction with the onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. Overall satisfaction will be measured with a single-item question utilizing a Likert scale with options ranging from very satisfied to very unsatisfied.
measure: Ease of Procedure
time frame: Immediately post-procedure
description: Physician's perception of ease of onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. This will be measured with a single item, five point Likert scale with options ranging from no difficulty to great difficulty.
measure: Office Efficiency/Total Appointment Duration
time frame: Immediately post-procedure
description: Total appointment time or total time spent in an office exam/procedure room in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. This will be measured by subtracting the appointment start time (time the patient was placed in the exam room) from the appointment end time (time of patient check-out).
arm group label: Oral Phenazopyridine
arm group type: Active Comparator
description: Patients randomized to the oral phenzopyridine arm will receive 200mg phenazopyridine to take by mouth 1-2 hours before their scheduled procedure.
arm group label: Intravesical Lidocaine
arm group type: Active Comparator
description: Patients randomized to the intravesical lidocaine arm will have the bladder back-filled with 30mL 2% lidocaine for the 20 minutes immediately preceding their procedure.
intervention type: Drug
intervention name: Phenazopyridine
description: 200mg PO Phenazopyridine taken 1-2 hours prior to the Botox® injection procedure
arm group label: Oral Phenazopyridine
intervention type: Drug
intervention name: Lidocaine 2% Injectable Solution
description: 30mL 2% lidocaine instilled into the bladder lumen 20 via a urinary catheter 20 minutes prior to the Botox® injection procedure
arm group label: Intravesical Lidocaine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Lauren E Stewart, MD
role: Principal Investigator
affiliation: Women and Infants Hospital of Rhode Island
last name: Lauren E Stewart, MD
phone: 401-453-7560
phone ext: 48762
email: lstewart@wihri.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Reflex, Abnormal
mesh term: Urinary Incontinence
mesh term: Urinary Bladder, Overactive
mesh term: Urinary Incontinence, Urge
mesh term: Lidocaine
sharing ipd: No