<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/NCT03825575</url>
  </required_header>
  <id_info>
    <org_study_id>McMasterChenFI</org_study_id>
    <nct_id>NCT03825575</nct_id>
  </id_info>
  <brief_title>Sacral Neuromodulation as Treatment for Fecal Incontinence</brief_title>
  <acronym>LLLT-FI</acronym>
  <official_title>Sacral Neuromodulation as Treatment for Fecal Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</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>
      The objective of this study is to investigate if low level laser therapy will do more good&#xD;
      than harm for patients with severe refractory fecal incontinence. It is a proof of concept&#xD;
      study without a placebo arm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The therapy consists of a 3 week treatment with a total of 8 sessions of low level laser&#xD;
      therapy. Effects will be assessed using symptoms and quality of life questionnaires and&#xD;
      physiological assessments of pelvic floor function, at 4 weeks and 12 weeks after beginning&#xD;
      of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 8, 2019</start_date>
  <completion_date type="Anticipated">February 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2025</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Proof of concept</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in number of fecal incontinence episodes</measure>
    <time_frame>4 weeks and 12 weeks</time_frame>
    <description>Number of fecal incontinence episodes per week</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>4 weeks and 12 weeks</time_frame>
    <description>The Fecal Incontinence Quality of Life Assessment is a subject-completed questionnaire. It is measured in each of four areas of depression/self-perception (7 items), lifestyle (10 items), coping (9 items), and embarrassment (3 items). Area scores are measured on a 1 (worse) to 4 (best) scale and are each the average of their component individual item scores measured on the same scale. The total score is the mean of all non-missing items. A negative change from baseline indicates improvement. Minimum important difference is 4 (Forte et al., 2016)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in symptoms score</measure>
    <time_frame>4 and 12 weeks</time_frame>
    <description>St. Mark's Incontinence (Vaizey) Score, it is a scale from 0-24 where 0=perfect continence and 24 is complete continence. Minimal important difference is 3 (Forte et al., 2016)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anal sphincter tone</measure>
    <time_frame>12 weeks</time_frame>
    <description>Anal sphincter tone (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in increase of anal sphincter pressure during squeezing</measure>
    <time_frame>12 weeks</time_frame>
    <description>Difference between anal sphincter squeeze pressure and resting pressure (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in squeezing duration</measure>
    <time_frame>12 weeks</time_frame>
    <description>Anal sphincter sustained squeezing duration (seconds)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Fecal Incontinence</condition>
  <arm_group>
    <arm_group_label>Incontinence and low level laser therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Low level laser therapy (sacral neuromodulation or photobiomodulation) will be administered to patients with fecal incontinence</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Low level laser therapy (LLLT)</intervention_name>
    <description>A 3 week treatment period with a total of 8 treatments of 1 hour over the sacral spinal cord</description>
    <arm_group_label>Incontinence and low level laser therapy</arm_group_label>
    <other_name>Sacral neuromodulation</other_name>
    <other_name>Photobiomodulation</other_name>
    <other_name>BioFlex laser stimulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with fecal incontinence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Known malignancies in the area of treatment&#xD;
&#xD;
          -  Active bleeding in area of treatment&#xD;
&#xD;
          -  Active deep vein thrombosis&#xD;
&#xD;
          -  When tatoos are present at area of treatment&#xD;
&#xD;
          -  Patients that are light sensitive&#xD;
&#xD;
          -  Patients who take steroids.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jihong Chen, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jihong Chen, MD PhD</last_name>
    <phone>1-226-3439909</phone>
    <email>chen338@mcmaster.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jan D Huizinga, PhD</last_name>
    <phone>1-226-3438888</phone>
    <email>huizinga@mcmaster.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>McMaster University</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N3Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jihong Chen, MD PhD</last_name>
      <email>chen338@mcmaster.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Forte ML, Andrade KE, Butler M, Lowry AC, Bliss DZ, Slavin JL, Kane RL. Treatments for Fecal Incontinence [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Mar. Report No.: 15(16)-EHC037-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK356097/</citation>
    <PMID>27099893</PMID>
  </reference>
  <reference>
    <citation>Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999 Jan;44(1):77-80. doi: 10.1136/gut.44.1.77.</citation>
    <PMID>9862829</PMID>
  </reference>
  <reference>
    <citation>Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.</citation>
    <PMID>10813117</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Jihong Chen</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Fecal Incontinence</keyword>
  <keyword>Anorectal manometry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fecal Incontinence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03825575
org study id: McMasterChenFI
nct id: NCT03825575
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to investigate if low level laser therapy will do more good
      than harm for patients with severe refractory fecal incontinence. It is a proof of concept
      study without a placebo arm.
The therapy consists of a 3 week treatment with a total of 8 sessions of low level laser
      therapy. Effects will be assessed using symptoms and quality of life questionnaires and
      physiological assessments of pelvic floor function, at 4 weeks and 12 weeks after beginning
      of treatment.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Proof of concept
primary purpose: Treatment
masking: None (Open Label)
measure: Change in number of fecal incontinence episodes
time frame: 4 weeks and 12 weeks
description: Number of fecal incontinence episodes per week
measure: Change in Quality of Life
time frame: 4 weeks and 12 weeks
description: The Fecal Incontinence Quality of Life Assessment is a subject-completed questionnaire. It is measured in each of four areas of depression/self-perception (7 items), lifestyle (10 items), coping (9 items), and embarrassment (3 items). Area scores are measured on a 1 (worse) to 4 (best) scale and are each the average of their component individual item scores measured on the same scale. The total score is the mean of all non-missing items. A negative change from baseline indicates improvement. Minimum important difference is 4 (Forte et al., 2016)
measure: Change in symptoms score
time frame: 4 and 12 weeks
description: St. Mark's Incontinence (Vaizey) Score, it is a scale from 0-24 where 0=perfect continence and 24 is complete continence. Minimal important difference is 3 (Forte et al., 2016)
measure: Change in anal sphincter tone
time frame: 12 weeks
description: Anal sphincter tone (mmHg)
measure: Change in increase of anal sphincter pressure during squeezing
time frame: 12 weeks
description: Difference between anal sphincter squeeze pressure and resting pressure (mmHg)
measure: Change in squeezing duration
time frame: 12 weeks
description: Anal sphincter sustained squeezing duration (seconds)
arm group label: Incontinence and low level laser therapy
arm group type: Experimental
description: Intervention: Low level laser therapy (sacral neuromodulation or photobiomodulation) will be administered to patients with fecal incontinence
intervention type: Device
intervention name: Low level laser therapy (LLLT)
description: A 3 week treatment period with a total of 8 treatments of 1 hour over the sacral spinal cord
arm group label: Incontinence and low level laser therapy
other name: Sacral neuromodulation
other name: Photobiomodulation
other name: BioFlex laser stimulation
criteria: 
gender: All
minimum age: 6 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jihong Chen, MD PhD
role: Principal Investigator
affiliation: McMaster University
last name: Jihong Chen, MD PhD
phone: 1-226-3439909
email: chen338@mcmaster.ca
last name: Jan D Huizinga, PhD
phone: 1-226-3438888
email: huizinga@mcmaster.ca
facility: 
status: Recruiting
contact: 
country: Canada
citation: Forte ML, Andrade KE, Butler M, Lowry AC, Bliss DZ, Slavin JL, Kane RL. Treatments for Fecal Incontinence [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Mar. Report No.: 15(16)-EHC037-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK356097/
PMID: 27099893
citation: Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999 Jan;44(1):77-80. doi: 10.1136/gut.44.1.77.
PMID: 9862829
citation: Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.
PMID: 10813117
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Jihong Chen
investigator title: Assistant Professor
mesh term: Fecal Incontinence
sharing ipd: Undecided