<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/NCT04440579</url>
  </required_header>
  <id_info>
    <org_study_id>145954</org_study_id>
    <nct_id>NCT04440579</nct_id>
  </id_info>
  <brief_title>Utilization of PTNS During Office-Based Cystoscopy</brief_title>
  <official_title>Utilization of Percutaneous Tibial Nerve Stimulation During Office-Based Cystoscopy: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas 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>
      This study will be a double-blind, randomized control trial, with one additional unblinded&#xD;
      arm. This study has been designed to identify a means of improving quality of life for&#xD;
      patients requiring in-office cystoscopy. Percutaneous tibial nerve stimulation (PTNS) has&#xD;
      been shown to improve quality of life and symptom control in multiple urological conditions&#xD;
      based on shared neuroanatomical structures between the genitourinary system and the tibial&#xD;
      nerve The goal of this project is to demonstrate the efficacy and safety of PTNS in&#xD;
      minimizing patient discomfort during cystoscopy to develop a larger randomized control trial&#xD;
      in the near future.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">August 2021</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>This study will be a double-blind, randomized control trial, with one additional unblinded arm. The two blinded arms will be PTNS and sham PTNS, with the additional unblinded arm being standard of care</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Discomfort</measure>
    <time_frame>One year</time_frame>
    <description>To assess the ability of percutaneous tibial nerve stimulation to improve patient discomfort during routine office-based cystoscopy based on a 10-point visual analogue scale (VAS) by comparing median and interquartile ranges between groups. A score of 0 will indicate no pain whereas a score of 10 indicates the worst pain imaginable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of PTNS: adverse events</measure>
    <time_frame>One year</time_frame>
    <description>To determine the safety of PTNS for use in the setting of routine office-based cystoscopy based on rate of adverse events as defined by the Clavien-Dindo classification system</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Cystoscopy</condition>
  <arm_group>
    <arm_group_label>Standard Cystoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will undergo a standard of care cystoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PTNS and Cystoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo PTNS while undergoing cystoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham PTN and Cystoscopy</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients will undergo a sham PTNS procedure while undergoing cystoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous Tibial Nerve Stimulation (PTNS)</intervention_name>
    <description>PTNS is neuromodulation that uses electricity to stimulate the nervous system, specifically the posterior tibial nerve, and is minimally invasive.</description>
    <arm_group_label>PTNS and Cystoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham Percutaneous Tibial Nerve Stimulation (PTNS)</intervention_name>
    <description>Patients will be connected to the PTNS device but the device will remain off for the entirety of the procedure</description>
    <arm_group_label>Sham PTN and Cystoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard Cystoscopy</intervention_name>
    <description>Patient will undergo standard cystoscopy</description>
    <arm_group_label>PTNS and Cystoscopy</arm_group_label>
    <arm_group_label>Sham PTN and Cystoscopy</arm_group_label>
    <arm_group_label>Standard Cystoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18 years of age or older&#xD;
&#xD;
          -  Patients undergoing routine office-based cystoscopy by a urology provider&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients for whom ancillary procedures are performed during cystoscopy, including&#xD;
             ureteral stent removal, bladder stone removal, biopsy, or fulguration&#xD;
&#xD;
          -  Patients undergoing cystoscopy due to concern for urologic injury&#xD;
&#xD;
          -  Patients undergoing cystoscopy due to concern for prosthetic abnormality, including&#xD;
             erosion or malposition&#xD;
&#xD;
          -  Patients who perform clean intermittent catheterization&#xD;
&#xD;
          -  Patients with pre-existing neurological pathology, including but not limited to&#xD;
             multiple sclerosis, spinal cord injury, Parkinson's disease, or peripheral neuropathy&#xD;
             of any etiology&#xD;
&#xD;
          -  Patients having undergone prior non-endoscopic prostatectomy (radical prostatectomy,&#xD;
             simple prostatectomy)&#xD;
&#xD;
          -  Patients with a history of interstitial cystitis/chronic pelvic pain&#xD;
&#xD;
          -  Patients who have taken an analgesic (excluding 81mg aspirin) in the past 12 hours&#xD;
&#xD;
          -  Patients with a history of urethral stricture disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Katherine Glavin</last_name>
    <phone>913-588-8721</phone>
    <email>kglavin@kumc.edu</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cystoscopy</keyword>
  <keyword>Urology</keyword>
  <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/NCT04440579
org study id: 145954
nct id: NCT04440579
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will be a double-blind, randomized control trial, with one additional unblinded
      arm. This study has been designed to identify a means of improving quality of life for
      patients requiring in-office cystoscopy. Percutaneous tibial nerve stimulation (PTNS) has
      been shown to improve quality of life and symptom control in multiple urological conditions
      based on shared neuroanatomical structures between the genitourinary system and the tibial
      nerve The goal of this project is to demonstrate the efficacy and safety of PTNS in
      minimizing patient discomfort during cystoscopy to develop a larger randomized control trial
      in the near future.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
masking description: This study will be a double-blind, randomized control trial, with one additional unblinded arm. The two blinded arms will be PTNS and sham PTNS, with the additional unblinded arm being standard of care
measure: Patient Discomfort
time frame: One year
description: To assess the ability of percutaneous tibial nerve stimulation to improve patient discomfort during routine office-based cystoscopy based on a 10-point visual analogue scale (VAS) by comparing median and interquartile ranges between groups. A score of 0 will indicate no pain whereas a score of 10 indicates the worst pain imaginable.
measure: Safety of PTNS: adverse events
time frame: One year
description: To determine the safety of PTNS for use in the setting of routine office-based cystoscopy based on rate of adverse events as defined by the Clavien-Dindo classification system
arm group label: Standard Cystoscopy
arm group type: Active Comparator
description: Patients will undergo a standard of care cystoscopy
arm group label: PTNS and Cystoscopy
arm group type: Experimental
description: Patients will undergo PTNS while undergoing cystoscopy
arm group label: Sham PTN and Cystoscopy
arm group type: Sham Comparator
description: Patients will undergo a sham PTNS procedure while undergoing cystoscopy
intervention type: Procedure
intervention name: Percutaneous Tibial Nerve Stimulation (PTNS)
description: PTNS is neuromodulation that uses electricity to stimulate the nervous system, specifically the posterior tibial nerve, and is minimally invasive.
arm group label: PTNS and Cystoscopy
intervention type: Procedure
intervention name: Sham Percutaneous Tibial Nerve Stimulation (PTNS)
description: Patients will be connected to the PTNS device but the device will remain off for the entirety of the procedure
arm group label: Sham PTN and Cystoscopy
intervention type: Procedure
intervention name: Standard Cystoscopy
description: Patient will undergo standard cystoscopy
arm group label: PTNS and Cystoscopy
arm group label: Sham PTN and Cystoscopy
arm group label: Standard Cystoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Katherine Glavin
phone: 913-588-8721
email: kglavin@kumc.edu
responsible party type: Sponsor
sharing ipd: No