<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/NCT03753750</url>
  </required_header>
  <id_info>
    <org_study_id>HS-18-00382</org_study_id>
    <nct_id>NCT03753750</nct_id>
  </id_info>
  <brief_title>Noninvasive Spinal Cord Stimulation for Neurogenic and Idiopathic Overactive Bladder</brief_title>
  <official_title>Evaluation of Noninvasive Spinal Cord Stimulation for Neurogenic and Idiopathic Overactive Bladder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</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>
      Overactive bladder (OAB) affects 12-30% of the world's population. The accompanying urinary&#xD;
      urgency, urinary frequency and incontinence can impair the ability to work, interact in&#xD;
      social activities and can result in poor social functioning. Multiple treatment modalities&#xD;
      are available for overactive bladder. However, each therapy has drawbacks that limit its&#xD;
      application in certain patient populations. For example, oral medications have significant&#xD;
      side effects and suffer from poor adherence. Botulinum toxin injection into the bladder wall&#xD;
      is invasive, requires re-treatment on a regular basis and carries a risk of urinary&#xD;
      retention. Current neuromodulatory techniques are invasive and require highly-specialized&#xD;
      care. Therefore, a need exists for a non-invasive, well-tolerated and easily administered&#xD;
      therapy for OAB. Transcutaneous spinal cord stimulation (TSCS) has been developed and tested&#xD;
      in able bodied individuals to initiate locomotor function as well as in the SCI population&#xD;
      for lower extremity and upper extremity function. More recently, we have tested this SCI&#xD;
      patients to enable lower urinary tract function and decrease detrusor overactivity, resulting&#xD;
      in improved continence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Insufficient enrollment due to COVID-19 pandemic&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 24, 2020</start_date>
  <completion_date type="Actual">January 1, 2022</completion_date>
  <primary_completion_date type="Actual">January 1, 2022</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>
    <intervention_model_description>Blinded sham-controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of urination and incontinence episodes over 72 hours</measure>
    <time_frame>4-12 weeks</time_frame>
    <description>A voiding diary records the amount of fluid intake, the number of urinations and the number of incontinence episodes over 72 hours. The number of daily urinations and incontinence episodes will be compared at the beginning and the conclusion of the study. Changes in the number of daily urinations and incontinence episodes will be compared between participants in the stimulation and sham arms of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Score on overactive bladder questionnaires</measure>
    <time_frame>4-12 weeks</time_frame>
    <description>Each participant will complete two validated questionnaires pertaining to overactive bladder: OAB-q and ICIQ-OAB. The OAB-q generates a total score ranging between 33 points (best) to 198 points (worst). The ICIQ-OAB generates a total score ranging between 0 points (best) to 58 points (worst). The questionnaires will be completed at the initiation and completion of the study. Change in questionnaire scores between initiation and completion of the study will be assessed. Changes in questionnaire scores will be compared between participants in the stimulation and sham arms of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cystometric bladder capacity, number of detrusor overactivity episodes during urodynamic studies.</measure>
    <time_frame>4-12 weeks</time_frame>
    <description>Urodynamic studies will be performed at the initiation and completion of the study. Urodynamic studies will be performed according to ICS (International Continence Society) criteria. Changes in cystometric capacity and number of detrusor overactivity episodes between initiation and completion of the study will be assessed. Changes in these parameters will be compared between participants in the stimulation and sham arms of the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Overactive Bladder</condition>
  <condition>Incontinence, Urge</condition>
  <condition>Neurogenic Bladder</condition>
  <arm_group>
    <arm_group_label>Actual stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects enrolled in the</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Noninvasive spinal cord stimulation</intervention_name>
    <description>Noninvasive spinal cord stimulation is a transcutaneous technique used to modulate the activity of the spinal cord. Subjects will undergo sham or actual stimulation 3-4 times a week for one hour at a time.</description>
    <arm_group_label>Actual stimulation</arm_group_label>
    <arm_group_label>Sham stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 18 and 80 years&#xD;
&#xD;
          2. Known diagnosis of overactive bladder, confirmed by:&#xD;
&#xD;
               -  presence of urinary frequency, urgency&#xD;
&#xD;
               -  frequent small-volume voids on frequency-volume chart&#xD;
&#xD;
               -  high score on ICIQ-OAB, ICIQ-OABQOL, and OAB-q questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Younger than 18 years of age&#xD;
&#xD;
          2. Older than 80 years of age&#xD;
&#xD;
          3. Presence of lower urinary tract symptoms suggestive of urinary retention or&#xD;
             obstruction&#xD;
&#xD;
          4. Finding of an elevated post-void residual (&gt;100 ml) on an ultrasonographic bladder&#xD;
             scan&#xD;
&#xD;
          5. History of spinal cord injury, spina bifida or other neurological disease affecting&#xD;
             the spinal cord&#xD;
&#xD;
          6. Acute or current urinary tract infection&#xD;
&#xD;
          7. History of neuromodulation for overactive bladder (sacral nerve stimulation or&#xD;
             peripheral tibial nerve stimulation)&#xD;
&#xD;
          8. Current or planned pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Evgeniy I Kreydin</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.</citation>
    <PMID>17049716</PMID>
  </reference>
  <reference>
    <citation>Gerasimenko Y, Gorodnichev R, Moshonkina T, Sayenko D, Gad P, Reggie Edgerton V. Transcutaneous electrical spinal-cord stimulation in humans. Ann Phys Rehabil Med. 2015 Sep;58(4):225-231. doi: 10.1016/j.rehab.2015.05.003. Epub 2015 Jul 20.</citation>
    <PMID>26205686</PMID>
  </reference>
  <reference>
    <citation>Gad PN, Kreydin E, Zhong H, Latack K, Edgerton VR. Non-invasive Neuromodulation of Spinal Cord Restores Lower Urinary Tract Function After Paralysis. Front Neurosci. 2018 Jun 29;12:432. doi: 10.3389/fnins.2018.00432. eCollection 2018.</citation>
    <PMID>30008661</PMID>
  </reference>
  <reference>
    <citation>Yoshimura N, Miyazato M, Kitta T, Yoshikawa S. Central nervous targets for the treatment of bladder dysfunction. Neurourol Urodyn. 2014 Jan;33(1):59-66. doi: 10.1002/nau.22455. Epub 2013 Jul 5.</citation>
    <PMID>23832777</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>May 5, 2022</last_update_submitted>
  <last_update_submitted_qc>May 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Evgeniy I. Kreydin</investigator_full_name>
    <investigator_title>Assistant Professor of Urology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Neurogenic</mesh_term>
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
    <mesh_term>Urinary Incontinence, Urge</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/NCT03753750
org study id: HS-18-00382
nct id: NCT03753750
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Overactive bladder (OAB) affects 12-30% of the world's population. The accompanying urinary
      urgency, urinary frequency and incontinence can impair the ability to work, interact in
      social activities and can result in poor social functioning. Multiple treatment modalities
      are available for overactive bladder. However, each therapy has drawbacks that limit its
      application in certain patient populations. For example, oral medications have significant
      side effects and suffer from poor adherence. Botulinum toxin injection into the bladder wall
      is invasive, requires re-treatment on a regular basis and carries a risk of urinary
      retention. Current neuromodulatory techniques are invasive and require highly-specialized
      care. Therefore, a need exists for a non-invasive, well-tolerated and easily administered
      therapy for OAB. Transcutaneous spinal cord stimulation (TSCS) has been developed and tested
      in able bodied individuals to initiate locomotor function as well as in the SCI population
      for lower extremity and upper extremity function. More recently, we have tested this SCI
      patients to enable lower urinary tract function and decrease detrusor overactivity, resulting
      in improved continence.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Blinded sham-controlled trial
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of urination and incontinence episodes over 72 hours
time frame: 4-12 weeks
description: A voiding diary records the amount of fluid intake, the number of urinations and the number of incontinence episodes over 72 hours. The number of daily urinations and incontinence episodes will be compared at the beginning and the conclusion of the study. Changes in the number of daily urinations and incontinence episodes will be compared between participants in the stimulation and sham arms of the study.
measure: Score on overactive bladder questionnaires
time frame: 4-12 weeks
description: Each participant will complete two validated questionnaires pertaining to overactive bladder: OAB-q and ICIQ-OAB. The OAB-q generates a total score ranging between 33 points (best) to 198 points (worst). The ICIQ-OAB generates a total score ranging between 0 points (best) to 58 points (worst). The questionnaires will be completed at the initiation and completion of the study. Change in questionnaire scores between initiation and completion of the study will be assessed. Changes in questionnaire scores will be compared between participants in the stimulation and sham arms of the study.
measure: Cystometric bladder capacity, number of detrusor overactivity episodes during urodynamic studies.
time frame: 4-12 weeks
description: Urodynamic studies will be performed at the initiation and completion of the study. Urodynamic studies will be performed according to ICS (International Continence Society) criteria. Changes in cystometric capacity and number of detrusor overactivity episodes between initiation and completion of the study will be assessed. Changes in these parameters will be compared between participants in the stimulation and sham arms of the study.
arm group label: Actual stimulation
arm group type: Experimental
description: Subjects enrolled in the
arm group label: Sham stimulation
arm group type: Sham Comparator
intervention type: Device
intervention name: Noninvasive spinal cord stimulation
description: Noninvasive spinal cord stimulation is a transcutaneous technique used to modulate the activity of the spinal cord. Subjects will undergo sham or actual stimulation 3-4 times a week for one hour at a time.
arm group label: Actual stimulation
arm group label: Sham stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Evgeniy I Kreydin
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
citation: Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
PMID: 17049716
citation: Gerasimenko Y, Gorodnichev R, Moshonkina T, Sayenko D, Gad P, Reggie Edgerton V. Transcutaneous electrical spinal-cord stimulation in humans. Ann Phys Rehabil Med. 2015 Sep;58(4):225-231. doi: 10.1016/j.rehab.2015.05.003. Epub 2015 Jul 20.
PMID: 26205686
citation: Gad PN, Kreydin E, Zhong H, Latack K, Edgerton VR. Non-invasive Neuromodulation of Spinal Cord Restores Lower Urinary Tract Function After Paralysis. Front Neurosci. 2018 Jun 29;12:432. doi: 10.3389/fnins.2018.00432. eCollection 2018.
PMID: 30008661
citation: Yoshimura N, Miyazato M, Kitta T, Yoshikawa S. Central nervous targets for the treatment of bladder dysfunction. Neurourol Urodyn. 2014 Jan;33(1):59-66. doi: 10.1002/nau.22455. Epub 2013 Jul 5.
PMID: 23832777
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Evgeniy I. Kreydin
investigator title: Assistant Professor of Urology
mesh term: Urinary Bladder, Neurogenic
mesh term: Urinary Bladder, Overactive
mesh term: Urinary Incontinence, Urge