<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/NCT04451382</url>
  </required_header>
  <id_info>
    <org_study_id>2014-277</org_study_id>
    <nct_id>NCT04451382</nct_id>
  </id_info>
  <brief_title>PTNS vs Botox of Refractory OAB</brief_title>
  <acronym>TROOP</acronym>
  <official_title>Treatment of Refractory Overactive Bladder (OAB) With OnabotulinumtoxinA vs. PTNS: TROOP Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medstar Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Methodist Urology Associates, Houston, Texas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medstar Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective cohort study of women with overactive bladder OAB (dry or wet) who have&#xD;
      failed 2 prior treatments, including behavioral modification, pelvic floor physical therapy,&#xD;
      and/or OAB medication (anticholinergics or mirabegron), and have chosen either&#xD;
      OnabotulinumtoxinA (BTX) injection or percutaneous tibial nerve stimulation (PTNS) as their&#xD;
      next treatment. OAB-dry refers to patients with OAB who do not have urge urinary&#xD;
      incontinence; OAB-wet refers to patients with OAB and urge urinary incontinence. Eligible&#xD;
      patients will be approached for study participation after they have decided to proceed with&#xD;
      BTX or PTNS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prior to initiation of BTX or PTNS, patients will undergo a standardized evaluation including&#xD;
      urodynamics study (UDS) if not previously done in the past year and pelvic organ prolapse&#xD;
      quantification (POPq) exam if not previously done in past 6 months. Subjects will also&#xD;
      complete quality of life questionnaires and 3-day voiding diary prior to initial treatment.&#xD;
      Follow up questionnaires will be completed at 3 months either in office, if patient has a&#xD;
      routine visit scheduled with provider and questionnaires can be completed at that visit or&#xD;
      questionnaires will be mailed with return postage for participant to mail completed&#xD;
      questionnaires back.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">March 2015</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Difference in patient global impression of improvement score between PTNS and BTX groups</measure>
    <time_frame>3 month</time_frame>
    <description>The Patient Global Impression of Improvement (PGI-I) is a single question that asks a patient to rate her urinary symptom response to treatment on a 7-point Likert scaleis a validated questionnaire for assessment of the impact of OAB on patient's lives.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in quality of life between PTNS and BTX groups</measure>
    <time_frame>3 month</time_frame>
    <description>The minimally important difference (MID) for change in SSS is 10 points. We compare the change in SS score between the PTNS and Botox groups at 3 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in individual question scores on OAB-q questionnaire</measure>
    <time_frame>3</time_frame>
    <description>The OAB-q consists of 33 items: an 8-item symptom bother scale (SS) and a 25-item health-related quality of life (HRQL) scale. Higher scores on HRQL scale represent better quality of life and lower scores on SSS is indicative of less bother.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in urinary symptom severity</measure>
    <time_frame>3</time_frame>
    <description>Tools used: Urogenital Distress Inventory short form (UDI-6) is a validated questionnaires used to assess urinary symptoms. We will compare change in scores between the 2 groups</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Overactive Bladder (OAB)</condition>
  <arm_group>
    <arm_group_label>OnabotulinumtoxinA (BoNTA)</arm_group_label>
    <description>DRUG: OnabotulinumtoxinA (BoNTA) is an injection into the bladder which blocks the presynaptic release of acetylcholine. BoNTA was approved for the treatment of OAB by the FDA in 2013.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Percutaneous tibial nerve stimulation (PTNS)</arm_group_label>
    <description>DEVICE: PTNS involves needle stimulation of the posterior tibial nerve and is typically performed with weekly 30 minute sessions for a 12 week treatment course.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>OnabotulinumtoxinA (BoNTA)</intervention_name>
    <arm_group_label>OnabotulinumtoxinA (BoNTA)</arm_group_label>
    <other_name>Botox</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous tibial nerve stimulation (PTNS)</intervention_name>
    <arm_group_label>Percutaneous tibial nerve stimulation (PTNS)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women with refractory OAB (dry or wet) who have failed 2 prior treatments, including&#xD;
        behavioral modification, pelvic floor physical therapy, and/or OAB medication&#xD;
        (antimuscarinics or mirabegron), and have chosen either BTX or PTNS as their next&#xD;
        treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women with refractory OAB (dry or wet)&#xD;
&#xD;
          2. OAB will be defined by a positive response and bother of &quot;somewhat, quite a bit, a&#xD;
             great deal, or a very great deal&quot; to question #3 or #8 on the OAB-q (see appendix B)&#xD;
             regarding urinary urgency and urgency incontinence.&#xD;
&#xD;
          3. Refractory will be defined as failure of 2 prior treatments, including behavioral&#xD;
             modification, pelvic floor physical therapy, and OAB medication (anticholinergics or&#xD;
             mirabegron). Trial of 2 medications that did not improve symptoms after 2 weeks or&#xD;
             could not be tolerated due to side effects will constitute 2 treatment failures.&#xD;
&#xD;
          4. Women with mixed urinary incontinence that is urge predominant will also be included.&#xD;
&#xD;
          5. Age ≥ 18 years&#xD;
&#xD;
          6. English speaking&#xD;
&#xD;
          7. Available for 1 year follow-up&#xD;
&#xD;
          8. Able to complete study questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Neurologic disease known to cause OAB including, but not limited to, Multiple&#xD;
             sclerosis, Parkinson's disease, and Spinal Cord Injury.&#xD;
&#xD;
          2. Pregnancy by self-report or pregnancy test&#xD;
&#xD;
          3. Contraindication to PTNS and/or BTX&#xD;
&#xD;
               -  PTNS: Pacemaker&#xD;
&#xD;
               -  BTX: myasthenia gravis, allergy to BTX, urinary retention (post void residual&#xD;
                  &gt;200cc)&#xD;
&#xD;
          4. Planned surgery for pelvic floor disorder during the study period&#xD;
&#xD;
          5. Prior treatment with BTX, PTNS, or sacral nerve stimulation (SNS) for refractory&#xD;
             OAB/urinary urge incontinence (UUI)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>MedStar Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>October 31, 2015</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medstar Health Research Institute</investigator_affiliation>
    <investigator_full_name>Robert Gutman</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_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/NCT04451382
org study id: 2014-277
nct id: NCT04451382
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This is a prospective cohort study of women with overactive bladder OAB (dry or wet) who have
      failed 2 prior treatments, including behavioral modification, pelvic floor physical therapy,
      and/or OAB medication (anticholinergics or mirabegron), and have chosen either
      OnabotulinumtoxinA (BTX) injection or percutaneous tibial nerve stimulation (PTNS) as their
      next treatment. OAB-dry refers to patients with OAB who do not have urge urinary
      incontinence; OAB-wet refers to patients with OAB and urge urinary incontinence. Eligible
      patients will be approached for study participation after they have decided to proceed with
      BTX or PTNS.
Prior to initiation of BTX or PTNS, patients will undergo a standardized evaluation including
      urodynamics study (UDS) if not previously done in the past year and pelvic organ prolapse
      quantification (POPq) exam if not previously done in past 6 months. Subjects will also
      complete quality of life questionnaires and 3-day voiding diary prior to initial treatment.
      Follow up questionnaires will be completed at 3 months either in office, if patient has a
      routine visit scheduled with provider and questionnaires can be completed at that visit or
      questionnaires will be mailed with return postage for participant to mail completed
      questionnaires back.
observational model: Cohort
time perspective: Prospective
measure: Difference in patient global impression of improvement score between PTNS and BTX groups
time frame: 3 month
description: The Patient Global Impression of Improvement (PGI-I) is a single question that asks a patient to rate her urinary symptom response to treatment on a 7-point Likert scaleis a validated questionnaire for assessment of the impact of OAB on patient's lives.
measure: Change in quality of life between PTNS and BTX groups
time frame: 3 month
description: The minimally important difference (MID) for change in SSS is 10 points. We compare the change in SS score between the PTNS and Botox groups at 3 months.
measure: Change in individual question scores on OAB-q questionnaire
time frame: 3
description: The OAB-q consists of 33 items: an 8-item symptom bother scale (SS) and a 25-item health-related quality of life (HRQL) scale. Higher scores on HRQL scale represent better quality of life and lower scores on SSS is indicative of less bother.
measure: Change in urinary symptom severity
time frame: 3
description: Tools used: Urogenital Distress Inventory short form (UDI-6) is a validated questionnaires used to assess urinary symptoms. We will compare change in scores between the 2 groups
arm group label: OnabotulinumtoxinA (BoNTA)
description: DRUG: OnabotulinumtoxinA (BoNTA) is an injection into the bladder which blocks the presynaptic release of acetylcholine. BoNTA was approved for the treatment of OAB by the FDA in 2013.
arm group label: Percutaneous tibial nerve stimulation (PTNS)
description: DEVICE: PTNS involves needle stimulation of the posterior tibial nerve and is typically performed with weekly 30 minute sessions for a 12 week treatment course.
intervention type: Biological
intervention name: OnabotulinumtoxinA (BoNTA)
arm group label: OnabotulinumtoxinA (BoNTA)
other name: Botox
intervention type: Procedure
intervention name: Percutaneous tibial nerve stimulation (PTNS)
arm group label: Percutaneous tibial nerve stimulation (PTNS)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medstar Health Research Institute
investigator full name: Robert Gutman
investigator title: MD
mesh term: Urinary Bladder, Overactive
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA