<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/NCT02992509</url>
  </required_header>
  <id_info>
    <org_study_id>5130321</org_study_id>
    <nct_id>NCT02992509</nct_id>
  </id_info>
  <brief_title>IVES for Treatment of UUI and OAB</brief_title>
  <official_title>EMED Detruset Intravesical Electrical Stimulation Catheter for Treatment of Urge Urinary Incontinence and Overactive Bladder Syndrome in Females</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loma Linda University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loma Linda University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The pilot study is intended to show the efficacy of intravesical electrical stimulation in&#xD;
      treating overactive bladder with or without frequency and/or urgency urinary incontinence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The EMED Technologies detrusetTM intravesical electrical stimulation (IVES) catheter is&#xD;
      indicated for use with the EMED detrusanTM 500 electrical generator for the treatment of&#xD;
      overactive bladder and urge urinary incontinence (UI) in women who are not satisfied with or&#xD;
      cannot tolerate other conservative treatments. EMED is interested in conducting a prospective&#xD;
      randomized multi-center study of IVES therapy vs conventional UI treatments. In order to gain&#xD;
      sufficient knowledge of the treatment effect and variability of IVES therapy to power an RCT,&#xD;
      a pilot study will be initially conducted.&#xD;
&#xD;
      The pilot study is intended to show the efficacy of IVES in treating overactive bladder with&#xD;
      or without frequency and/or urgency urinary incontinence with safety profile of IVES being no&#xD;
      worse than with standard urological catheters.&#xD;
&#xD;
      A primary endpoint at 3 months showing reduction in incontinence events via a 7-level patient&#xD;
      global impression of improvement will be established. Secondary endpoints will include PCI&#xD;
      for subsets of symptoms, 3 day voiding diary, and patient satisfaction questionnaires.&#xD;
&#xD;
      Follow up at end of therapy and 3 months from the first therapy session will be conducted.&#xD;
      6-month, 9-month, and 12-month follow up can be conducted to establish durability of IVES&#xD;
      therapy if it is found to be effective at 3 months after the first treatment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in incontinence</measure>
    <time_frame>3 months</time_frame>
    <description>Primary endpoint is a reduction in incontinence events at 3 months post treatment as determined by a 7 point patient global impression of improvement</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Urinary Bladder, Overactive</condition>
  <condition>Urinary Incontinence, Urge</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This pilot study group is a prospective observational study. It is not blinded and there is no control. This is a single arm study (treatment group) which will receive intravesical electrical stimulation with a total of 8 therapy sessions, each lasting 15 minutes. The sessions will be done in a serial fashion, 2 per week for 4 consecutive weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EMED detruset(TM) intravesical electrical stimulation</intervention_name>
    <description>There will be a total of 8 therapy sessions, each lasting 15 minutes. The sessions will be done in a serial fashion, 2 per week for 4 consecutive weeks. The electrical parameters utilized will be those previously determined to be appropriate for OAB and UUI. As the beneficial effect of electrical stimulation is dependent on a &quot;maximal&quot; level of stimulation, the stimulation voltage will be increased during the first minute of treatment until the maximum tolerated by the patient is established and then backed-off by 1-2 Volts. The therapy will continue for 15 minutes in total for each session. The VAS will be marked by the patient before each treatment session throughout the therapy period, and other questionnaires will be administered.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  18-90 years old&#xD;
&#xD;
          -  Urinary urge incontinence OR overactive bladder&#xD;
&#xD;
          -  Prior trial of medical treatment for UUI or OAB&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pelvic organ prolapse greater than stage 1&#xD;
&#xD;
          -  multiple sclerosis&#xD;
&#xD;
          -  parkinson's disease&#xD;
&#xD;
          -  spinal cord injury&#xD;
&#xD;
          -  long-term DM type I&#xD;
&#xD;
          -  prior surgeries that may affect innervation of the detrusor nerves or the spinal cord&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  pacemaker/defibrillator&#xD;
&#xD;
          -  PVR &gt;150ml&#xD;
&#xD;
          -  dementia&#xD;
&#xD;
          -  Stress urinary incontinence&#xD;
&#xD;
          -  intravesical botox injection within 1 year, PTNS within 6 months, or medical treatment&#xD;
             for OAB within 3 weeks; bulking agent injection within 6 months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sam Siddighi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loma Linda University Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loma Linda University Health</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hagerty JA, Richards I, Kaplan WE. Intravesical electrotherapy for neurogenic bladder dysfunction: a 22-year experience. J Urol. 2007 Oct;178(4 Pt 2):1680-3; discussion 1683. doi: 10.1016/j.juro.2007.03.188. Epub 2007 Aug 17.</citation>
    <PMID>17707024</PMID>
  </reference>
  <reference>
    <citation>Cheng EY, Richards I, Balcom A, Steinhardt G, Diamond M, Rich M, Donovan JM, Carr MC, Reinberg Y, Hurt G, Chandra M, Bauer SB, Kaplan WE. Bladder stimulation therapy improves bladder compliance: results from a multi-institutional trial. J Urol. 1996 Aug;156(2 Pt 2):761-4.</citation>
    <PMID>8683778</PMID>
  </reference>
  <reference>
    <citation>Hong CH, Lee HY, Jin MH, Noh JY, Lee BH, Han SW. The effect of intravesical electrical stimulation on bladder function and synaptic neurotransmission in the rat spinal cord after spinal cord injury. BJU Int. 2009 Apr;103(8):1136-41. doi: 10.1111/j.1464-410X.2008.08189.x. Epub 2008 Nov 18.</citation>
    <PMID>19021629</PMID>
  </reference>
  <reference>
    <citation>Lombardi G, Musco S, Celso M, Ierardi A, Nelli F, Del Corso F, Del Popolo G. Intravesical electrostimulation versus sacral neuromodulation for incomplete spinal cord patients suffering from neurogenic non-obstructive urinary retention. Spinal Cord. 2013 Jul;51(7):571-8. doi: 10.1038/sc.2013.37. Epub 2013 Apr 30.</citation>
    <PMID>23628893</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 30, 2016</last_update_submitted>
  <last_update_submitted_qc>December 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Loma Linda University</investigator_affiliation>
    <investigator_full_name>Sam Siddighi, MD</investigator_full_name>
    <investigator_title>Urogynecology/Pelvic Surgery, FPMRS</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
    <mesh_term>Urinary Incontinence, Urge</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No IPD will be shared</ipd_description>
  </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/NCT02992509
org study id: 5130321
nct id: NCT02992509
lead sponsor: 
has dmc: Yes
The pilot study is intended to show the efficacy of intravesical electrical stimulation in
      treating overactive bladder with or without frequency and/or urgency urinary incontinence.
The EMED Technologies detrusetTM intravesical electrical stimulation (IVES) catheter is
      indicated for use with the EMED detrusanTM 500 electrical generator for the treatment of
      overactive bladder and urge urinary incontinence (UI) in women who are not satisfied with or
      cannot tolerate other conservative treatments. EMED is interested in conducting a prospective
      randomized multi-center study of IVES therapy vs conventional UI treatments. In order to gain
      sufficient knowledge of the treatment effect and variability of IVES therapy to power an RCT,
      a pilot study will be initially conducted.

      The pilot study is intended to show the efficacy of IVES in treating overactive bladder with
      or without frequency and/or urgency urinary incontinence with safety profile of IVES being no
      worse than with standard urological catheters.

      A primary endpoint at 3 months showing reduction in incontinence events via a 7-level patient
      global impression of improvement will be established. Secondary endpoints will include PCI
      for subsets of symptoms, 3 day voiding diary, and patient satisfaction questionnaires.

      Follow up at end of therapy and 3 months from the first therapy session will be conducted.
      6-month, 9-month, and 12-month follow up can be conducted to establish durability of IVES
      therapy if it is found to be effective at 3 months after the first treatment
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction in incontinence
time frame: 3 months
description: Primary endpoint is a reduction in incontinence events at 3 months post treatment as determined by a 7 point patient global impression of improvement
arm group label: Treatment
arm group type: Other
description: This pilot study group is a prospective observational study. It is not blinded and there is no control. This is a single arm study (treatment group) which will receive intravesical electrical stimulation with a total of 8 therapy sessions, each lasting 15 minutes. The sessions will be done in a serial fashion, 2 per week for 4 consecutive weeks.
intervention type: Device
intervention name: EMED detruset(TM) intravesical electrical stimulation
description: There will be a total of 8 therapy sessions, each lasting 15 minutes. The sessions will be done in a serial fashion, 2 per week for 4 consecutive weeks. The electrical parameters utilized will be those previously determined to be appropriate for OAB and UUI. As the beneficial effect of electrical stimulation is dependent on a "maximal" level of stimulation, the stimulation voltage will be increased during the first minute of treatment until the maximum tolerated by the patient is established and then backed-off by 1-2 Volts. The therapy will continue for 15 minutes in total for each session. The VAS will be marked by the patient before each treatment session throughout the therapy period, and other questionnaires will be administered.
arm group label: Treatment
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Sam Siddighi, MD
role: Principal Investigator
affiliation: Loma Linda University Health
facility: 
country: United States
citation: Hagerty JA, Richards I, Kaplan WE. Intravesical electrotherapy for neurogenic bladder dysfunction: a 22-year experience. J Urol. 2007 Oct;178(4 Pt 2):1680-3; discussion 1683. doi: 10.1016/j.juro.2007.03.188. Epub 2007 Aug 17.
PMID: 17707024
citation: Cheng EY, Richards I, Balcom A, Steinhardt G, Diamond M, Rich M, Donovan JM, Carr MC, Reinberg Y, Hurt G, Chandra M, Bauer SB, Kaplan WE. Bladder stimulation therapy improves bladder compliance: results from a multi-institutional trial. J Urol. 1996 Aug;156(2 Pt 2):761-4.
PMID: 8683778
citation: Hong CH, Lee HY, Jin MH, Noh JY, Lee BH, Han SW. The effect of intravesical electrical stimulation on bladder function and synaptic neurotransmission in the rat spinal cord after spinal cord injury. BJU Int. 2009 Apr;103(8):1136-41. doi: 10.1111/j.1464-410X.2008.08189.x. Epub 2008 Nov 18.
PMID: 19021629
citation: Lombardi G, Musco S, Celso M, Ierardi A, Nelli F, Del Corso F, Del Popolo G. Intravesical electrostimulation versus sacral neuromodulation for incomplete spinal cord patients suffering from neurogenic non-obstructive urinary retention. Spinal Cord. 2013 Jul;51(7):571-8. doi: 10.1038/sc.2013.37. Epub 2013 Apr 30.
PMID: 23628893
responsible party type: Principal Investigator
investigator affiliation: Loma Linda University
investigator full name: Sam Siddighi, MD
investigator title: Urogynecology/Pelvic Surgery, FPMRS
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Bladder, Overactive
mesh term: Urinary Incontinence, Urge
sharing ipd: No
ipd description: No IPD will be shared