<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/NCT04448171</url>
  </required_header>
  <id_info>
    <org_study_id>20-003510</org_study_id>
    <nct_id>NCT04448171</nct_id>
  </id_info>
  <brief_title>TENS Used for Pain Management During Office Cystoscopy Botox Injections</brief_title>
  <official_title>Transcutaneous Electric Nerve Stimulation For Pain Control During Office Intra-detrusor Onabotulinumtoxin A Cystoscopy Injection for Overactive Bladder: A Phase III Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine how Transcutaneous Electric Nerve Stimulation&#xD;
      (TENS) units affects pain management during office cystoscopic Botox injections and patient&#xD;
      satisfaction with the procedure .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overactive bladder (OAB) is a symptom complex pronounced by urinary urgency, affecting up to&#xD;
      12% of the adult population, with a significant negative impact quality on the life.&#xD;
      Cystoscopic intra-detrusor onabotulinumtoxin A is used for the treatment of OAB in&#xD;
      participants who do not tolerate or adequately respond to oral anticholinergic medications.&#xD;
      The response to the onabotulinumtoxin A injection is transient and requires repeat injections&#xD;
      roughly every 6-7 months. Adequate pain control during this procedure is essential for&#xD;
      success in the office setting.&#xD;
&#xD;
      Options for adequate pain control during office-based cystoscopy procedures are limited.&#xD;
      Currently, varying pain control strategies are being used including local anesthesia&#xD;
      (intra-urethral lidocaine, intra-vesicular lidocaine solution), distraction techniques&#xD;
      (conversation/music/'squeeze balls'), aromatherapy, intramuscular analgesia, sedation and a&#xD;
      combination of these techniques. Despite this, participants often experience pain during the&#xD;
      procedure. Trans-cutaneous Electrical Nerve Stimulation (TENS) is a non-pharmacologic,&#xD;
      non-invasive and safe method of pain control that involves delivery of electrical impulses to&#xD;
      the skin, resulting in a reduction in perceived pain. TENS units have been successfully used&#xD;
      for procedural pain management during office hysteroscopy and office colonoscopy. TENS may&#xD;
      also help reduce pain during office cystoscopy.&#xD;
&#xD;
      The study is a two arm phase III double-blind, randomized, placebo-controlled trial looking&#xD;
      at the effect of TENS unit on pain in participants receiving office based cystoscopic&#xD;
      onabotulinum toxin A injection for overactive bladder at the Mayo Clinic in Rochester,&#xD;
      Minnesota.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 28, 2020</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>The participant, the physician administering the Botox, and the study coordinator (outcomes assessor) assigned to the study will be blinded to the randomization. Both groups of participants will receive the TENS unit electrode placement by the assigned clinical nurse who is not blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Assess whether the TENS units is effective over standard pain control measures for intra-procedure pain management during office cystoscopic Intra-detrusor Onabotulinumtoxin A in women with OAB.</measure>
    <time_frame>Baseline to intra-procedure</time_frame>
    <description>Compare the change in participant-reported numerical pain score using a 0-10 numerical pain scale at baseline and intra-procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effect of TENS units on participant satisfaction following cystoscopic intra-detrusor onabotulinumtoxin A injection in women with OAB.</measure>
    <time_frame>Postprocedure, 10 minutes following completion of cystoscopy</time_frame>
    <description>Evaluate participant satisfaction using a 10 point Likert scale (1=complete dissatisfaction and 10=complete satisfaction)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Overactive Bladder</condition>
  <arm_group>
    <arm_group_label>Activated TENS Unit with standard pain control measures</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Activated TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham TENS Unit with standard pain control measures</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sham TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active TENS</intervention_name>
    <description>Standard TENS unit with four pads affixed to the lower back area, will be used in this arm. The TENS device will be set to an active setting.</description>
    <arm_group_label>Activated TENS Unit with standard pain control measures</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham TENS</intervention_name>
    <description>Standard TENS unit with four pads affixed to the lower back area, will be used in this arm. The TENS device will be set to an inactive setting.</description>
    <arm_group_label>Sham TENS Unit with standard pain control measures</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females age 18 years or older&#xD;
&#xD;
          -  Scheduled to receive intra-detrusor Onabotulinumtoxin-A injection for Overactive&#xD;
             Bladder in the outpatient clinic&#xD;
&#xD;
          -  Reads, speaks, and understands the English language&#xD;
&#xD;
          -  Able to understand the requirements of the study, including randomization&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous use of TENS therapy within one year prior to study enrollment&#xD;
&#xD;
          -  Has a spouse or first degree relative who has previously used TENS therapy within one&#xD;
             year prior to study enrollment&#xD;
&#xD;
          -  Currently has an implanted pacemaker or automatic cardiac defibrillator&#xD;
&#xD;
          -  History of epilepsy&#xD;
&#xD;
          -  Currently pregnant or within 12 weeks postpartum&#xD;
&#xD;
          -  Unwilling to be randomized&#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>John A Occhino, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Karen P Ishitani, MSN</last_name>
    <phone>507-538-5355</phone>
    <email>ishitani.karen@mayo.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maureen A Lemens, BSN</last_name>
    <phone>507-293-1487</phone>
    <email>lemens.maureen@mayo.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karen P Ishitani, MSN</last_name>
      <phone>507-538-5355</phone>
      <email>ishitani.karen@mayo.edu</email>
    </contact>
    <contact_backup>
      <last_name>Maureen A Lemens, BSN</last_name>
      <phone>507-293-1487</phone>
      <email>lemens.maureen@mayo.edu</email>
    </contact_backup>
    <investigator>
      <last_name>John A Occhino, MD, MS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>July 13, 2023</last_update_submitted>
  <last_update_submitted_qc>July 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>John A. Occhino</investigator_full_name>
    <investigator_title>Associate Professor of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <keyword>Overactive Bladder</keyword>
  <keyword>Botox injection - bladder</keyword>
  <keyword>TENS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</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/NCT04448171
org study id: 20-003510
nct id: NCT04448171
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to determine how Transcutaneous Electric Nerve Stimulation
      (TENS) units affects pain management during office cystoscopic Botox injections and patient
      satisfaction with the procedure .
Overactive bladder (OAB) is a symptom complex pronounced by urinary urgency, affecting up to
      12% of the adult population, with a significant negative impact quality on the life.
      Cystoscopic intra-detrusor onabotulinumtoxin A is used for the treatment of OAB in
      participants who do not tolerate or adequately respond to oral anticholinergic medications.
      The response to the onabotulinumtoxin A injection is transient and requires repeat injections
      roughly every 6-7 months. Adequate pain control during this procedure is essential for
      success in the office setting.

      Options for adequate pain control during office-based cystoscopy procedures are limited.
      Currently, varying pain control strategies are being used including local anesthesia
      (intra-urethral lidocaine, intra-vesicular lidocaine solution), distraction techniques
      (conversation/music/'squeeze balls'), aromatherapy, intramuscular analgesia, sedation and a
      combination of these techniques. Despite this, participants often experience pain during the
      procedure. Trans-cutaneous Electrical Nerve Stimulation (TENS) is a non-pharmacologic,
      non-invasive and safe method of pain control that involves delivery of electrical impulses to
      the skin, resulting in a reduction in perceived pain. TENS units have been successfully used
      for procedural pain management during office hysteroscopy and office colonoscopy. TENS may
      also help reduce pain during office cystoscopy.

      The study is a two arm phase III double-blind, randomized, placebo-controlled trial looking
      at the effect of TENS unit on pain in participants receiving office based cystoscopic
      onabotulinum toxin A injection for overactive bladder at the Mayo Clinic in Rochester,
      Minnesota.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: The participant, the physician administering the Botox, and the study coordinator (outcomes assessor) assigned to the study will be blinded to the randomization. Both groups of participants will receive the TENS unit electrode placement by the assigned clinical nurse who is not blinded.
measure: Assess whether the TENS units is effective over standard pain control measures for intra-procedure pain management during office cystoscopic Intra-detrusor Onabotulinumtoxin A in women with OAB.
time frame: Baseline to intra-procedure
description: Compare the change in participant-reported numerical pain score using a 0-10 numerical pain scale at baseline and intra-procedure.
measure: Evaluate the effect of TENS units on participant satisfaction following cystoscopic intra-detrusor onabotulinumtoxin A injection in women with OAB.
time frame: Postprocedure, 10 minutes following completion of cystoscopy
description: Evaluate participant satisfaction using a 10 point Likert scale (1=complete dissatisfaction and 10=complete satisfaction)
arm group label: Activated TENS Unit with standard pain control measures
arm group type: Active Comparator
description: Activated TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
arm group label: Sham TENS Unit with standard pain control measures
arm group type: Placebo Comparator
description: Sham TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
intervention type: Device
intervention name: Active TENS
description: Standard TENS unit with four pads affixed to the lower back area, will be used in this arm. The TENS device will be set to an active setting.
arm group label: Activated TENS Unit with standard pain control measures
intervention type: Device
intervention name: Sham TENS
description: Standard TENS unit with four pads affixed to the lower back area, will be used in this arm. The TENS device will be set to an inactive setting.
arm group label: Sham TENS Unit with standard pain control measures
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John A Occhino, MD, MS
role: Principal Investigator
affiliation: Mayo Clinic
last name: Karen P Ishitani, MSN
phone: 507-538-5355
email: ishitani.karen@mayo.edu
last name: Maureen A Lemens, BSN
phone: 507-293-1487
email: lemens.maureen@mayo.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: John A. Occhino
investigator title: Associate Professor of Obstetrics and Gynecology
mesh term: Urinary Bladder, Overactive