<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/NCT04502810</url>
  </required_header>
  <id_info>
    <org_study_id>#2020-3535</org_study_id>
    <nct_id>NCT04502810</nct_id>
  </id_info>
  <brief_title>High-level Laser for Provoked Vestibulodynia</brief_title>
  <official_title>A Feasibility and Acceptability Study of High-level Laser for Women With Provoked Vestibulodynia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Sherbrooke</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre de recherche du Centre hospitalier universitaire de Sherbrooke</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Exogenia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Université de Sherbrooke</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 is a randomized feasibility and acceptability study investigating the effects of laser&#xD;
      treatment in women suffering from provoked vestibulodynia compared to a sham-laser treatment.&#xD;
      Participants will be randomized into the laser group or sham-laser group. The laser group&#xD;
      will receive 12 sessions of real high-level laser therapy (HILT) (30-minutes biweekly for 6&#xD;
      consecutive weeks). The sham-laser group will receive 12 sessions (30-minutes biweekly for 6&#xD;
      consecutive weeks) of laser therapy using a deactivated probe. Outcomes measures will be&#xD;
      assessed at baseline and at post-treatment and will include: feasibility and acceptability&#xD;
      variables, pain, sexual function, sexual distress, psychological variables and perceived&#xD;
      improvement after the treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">May 4, 2021</completion_date>
  <primary_completion_date type="Actual">May 4, 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>
    <intervention_model_description>Baseline evaluation - Randomization to real laser or sham laser (12 sessions in 6 consecutive weeks) - Post-treatment evaluation</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence rate</measure>
    <time_frame>2-week post-treatment evaluation</time_frame>
    <description>To determine acceptability by assessing adherence to treatment sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of satisfaction with the treatment</measure>
    <time_frame>2-week post-treatment evaluation</time_frame>
    <description>To determine acceptability by measuring the participants' satisfaction with the treatment on a numeric rating scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Willingness to recommend the treatment</measure>
    <time_frame>2-week post-treatment evaluation</time_frame>
    <description>To determine acceptability by assessing whether the participant would recommend the treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of adverse events</measure>
    <time_frame>2-week post-treatment evaluation</time_frame>
    <description>To document any adverse events.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blinding effectiveness</measure>
    <time_frame>2-week post-treatment evaluation</time_frame>
    <description>To assess the feasibility of maintaining blinding to group allocation for the therapists, assessors and therapists. Evaluated by asking the question: ''What treatment do you think you have received / given? ''</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>Baseline to 2-week post-treatment evaluation</time_frame>
    <description>To assess the recruitment rate including the barriers and reasons for refusing to participate as well as the reasons for exclusion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Completion and dropout rates</measure>
    <time_frame>2-week post-treatment evaluation</time_frame>
    <description>To evaluate completion and dropout rates based on the completion of the post-treatment evaluation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Completeness of data</measure>
    <time_frame>Baseline to 2-week post-treatment evaluation</time_frame>
    <description>To examine the percentage of completed outcome measures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in pain intensity during intercourse</measure>
    <time_frame>Baseline to 2-week post-treatment evaluation</time_frame>
    <description>To explore changes in pain intensity during intercourse (Numerical Rating Scale, ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sexual function</measure>
    <time_frame>Baseline to 2-week post-treatment evaluation</time_frame>
    <description>To explore changes in sexual function (Female Sexual Function Index). Minimum value: 2, Maximum value: 36 and lower scores mean worst outcome (low sexual function).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sexual distress</measure>
    <time_frame>Baseline to 2-week post-treatment evaluation</time_frame>
    <description>To explore changes in sexual distress (Female Sexual Distress Scale ). Minimum value: 0, Maximum value: 52, higher scores mean worst outcome (higher sexually related distress).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain quality</measure>
    <time_frame>Baseline to 2-week post-treatment evaluation</time_frame>
    <description>To explore changes on the sensory, affective and evaluative components of pain (McGill-Melzack Questionnaire). Minimum value: 0, Maximum value: 78, higher scores mean worst outcome (higher pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's global impression of change</measure>
    <time_frame>Baseline to 2-week post-treatment evaluation</time_frame>
    <description>To examine patient self-reported improvement (Patient's Global Impression of Change ranging from &quot;very much worse&quot; to &quot;very much improved&quot; on a 7-point scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fear of pain</measure>
    <time_frame>Baseline to 2-week post-treatment evaluation</time_frame>
    <description>To explore changes in fear of pain (Pain Anxiety Symptoms Scale (PASS-20)). Minimum value: 0, Maximum value: 100, higher scores mean worst outcome (higher fear of pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain catastrophization</measure>
    <time_frame>Baseline to 2-week post-treatment evaluation</time_frame>
    <description>To explore changes in pain catastrophization (Pain Catastrophizing Scale (PCS)). Minimum value: 0, Maximum value: 52, higher scores mean worse outcome (higher pain catastrophization)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in vulvar pain sensitivity</measure>
    <time_frame>Baseline to 2-week post-treatment evaluation</time_frame>
    <description>To explore changes in vulvar pain sensitivity (algometer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in vulvar blood circulation</measure>
    <time_frame>Baseline to 2-week post-treatment evaluation</time_frame>
    <description>To explore changes in vulvar blood circulation using the laser speckle. Vulvar vestibule blood perfusion is expressed in arbitrary perfusion units (APUs).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Vulvodynia</condition>
  <arm_group>
    <arm_group_label>High-level laser therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Real high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham High-level laser therapy</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments)</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>High-level laser therapy</intervention_name>
    <description>Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area.</description>
    <arm_group_label>High-level laser therapy</arm_group_label>
    <arm_group_label>Sham High-level laser therapy</arm_group_label>
    <other_name>Nd:Yag laser</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderate to severe pain (≥5/10) during sexual intercourse for at least 3 months&#xD;
&#xD;
          -  Moderate to severe pain (≥5/10) in at least 90% of sexual intercourses or attempted&#xD;
             sexual intercourse for at least 3 months&#xD;
&#xD;
          -  Provoked vestibulodynia lasting at least 3 months prior to the study and diagnosed by&#xD;
             a standardised gynaecologic exam&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other causes of vulvo-vaginal pain (e.g. spontaneous vulvovaginal pain not related to&#xD;
             sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy)&#xD;
&#xD;
          -  Post-menopausal state&#xD;
&#xD;
          -  Actual or past pregnancy in the last year&#xD;
&#xD;
          -  Urogynecological condition (e.g. pelvic organs prolapse ≥3, urinary/vaginal infection&#xD;
             active or in the last 3 months)&#xD;
&#xD;
          -  Anterior vulvar, vaginal or pelvic surgery (e.g. vestibulectomy, corrective pelvic&#xD;
             organs prolapses surgery)&#xD;
&#xD;
          -  Prior use of laser treatments for vulvar pain&#xD;
&#xD;
          -  Expected changes of medication that could influence pain perception (e.g. analgesic,&#xD;
             antidepressant)&#xD;
&#xD;
          -  Other medical conditions that could interfere with the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mélanie Morin, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Université de Sherbrooke</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre hospitalier Universitaire de Sherbroke</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>January 26, 2022</last_update_submitted>
  <last_update_submitted_qc>January 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université de Sherbrooke</investigator_affiliation>
    <investigator_full_name>Mélanie Morin</investigator_full_name>
    <investigator_title>Researcher and Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Laser</keyword>
  <keyword>Provoked vestibulodynia</keyword>
  <keyword>Pain</keyword>
  <keyword>Sexual dysfunctions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vulvodynia</mesh_term>
    <mesh_term>Vulvar Vestibulitis</mesh_term>
  </condition_browse>
  <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/NCT04502810
org study id: #2020-3535
nct id: NCT04502810
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized feasibility and acceptability study investigating the effects of laser
      treatment in women suffering from provoked vestibulodynia compared to a sham-laser treatment.
      Participants will be randomized into the laser group or sham-laser group. The laser group
      will receive 12 sessions of real high-level laser therapy (HILT) (30-minutes biweekly for 6
      consecutive weeks). The sham-laser group will receive 12 sessions (30-minutes biweekly for 6
      consecutive weeks) of laser therapy using a deactivated probe. Outcomes measures will be
      assessed at baseline and at post-treatment and will include: feasibility and acceptability
      variables, pain, sexual function, sexual distress, psychological variables and perceived
      improvement after the treatment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Baseline evaluation - Randomization to real laser or sham laser (12 sessions in 6 consecutive weeks) - Post-treatment evaluation
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adherence rate
time frame: 2-week post-treatment evaluation
description: To determine acceptability by assessing adherence to treatment sessions
measure: Level of satisfaction with the treatment
time frame: 2-week post-treatment evaluation
description: To determine acceptability by measuring the participants' satisfaction with the treatment on a numeric rating scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied)
measure: Willingness to recommend the treatment
time frame: 2-week post-treatment evaluation
description: To determine acceptability by assessing whether the participant would recommend the treatment.
measure: Rate of adverse events
time frame: 2-week post-treatment evaluation
description: To document any adverse events.
measure: Blinding effectiveness
time frame: 2-week post-treatment evaluation
description: To assess the feasibility of maintaining blinding to group allocation for the therapists, assessors and therapists. Evaluated by asking the question: ''What treatment do you think you have received / given? ''
measure: Recruitment rate
time frame: Baseline to 2-week post-treatment evaluation
description: To assess the recruitment rate including the barriers and reasons for refusing to participate as well as the reasons for exclusion
measure: Completion and dropout rates
time frame: 2-week post-treatment evaluation
description: To evaluate completion and dropout rates based on the completion of the post-treatment evaluation.
measure: Completeness of data
time frame: Baseline to 2-week post-treatment evaluation
description: To examine the percentage of completed outcome measures.
measure: Change in pain intensity during intercourse
time frame: Baseline to 2-week post-treatment evaluation
description: To explore changes in pain intensity during intercourse (Numerical Rating Scale, ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever)
measure: Change in sexual function
time frame: Baseline to 2-week post-treatment evaluation
description: To explore changes in sexual function (Female Sexual Function Index). Minimum value: 2, Maximum value: 36 and lower scores mean worst outcome (low sexual function).
measure: Change in sexual distress
time frame: Baseline to 2-week post-treatment evaluation
description: To explore changes in sexual distress (Female Sexual Distress Scale ). Minimum value: 0, Maximum value: 52, higher scores mean worst outcome (higher sexually related distress).
measure: Change in pain quality
time frame: Baseline to 2-week post-treatment evaluation
description: To explore changes on the sensory, affective and evaluative components of pain (McGill-Melzack Questionnaire). Minimum value: 0, Maximum value: 78, higher scores mean worst outcome (higher pain).
measure: Patient's global impression of change
time frame: Baseline to 2-week post-treatment evaluation
description: To examine patient self-reported improvement (Patient's Global Impression of Change ranging from "very much worse" to "very much improved" on a 7-point scale.
measure: Change in fear of pain
time frame: Baseline to 2-week post-treatment evaluation
description: To explore changes in fear of pain (Pain Anxiety Symptoms Scale (PASS-20)). Minimum value: 0, Maximum value: 100, higher scores mean worst outcome (higher fear of pain).
measure: Change in pain catastrophization
time frame: Baseline to 2-week post-treatment evaluation
description: To explore changes in pain catastrophization (Pain Catastrophizing Scale (PCS)). Minimum value: 0, Maximum value: 52, higher scores mean worse outcome (higher pain catastrophization)
measure: Change in vulvar pain sensitivity
time frame: Baseline to 2-week post-treatment evaluation
description: To explore changes in vulvar pain sensitivity (algometer)
measure: Change in vulvar blood circulation
time frame: Baseline to 2-week post-treatment evaluation
description: To explore changes in vulvar blood circulation using the laser speckle. Vulvar vestibule blood perfusion is expressed in arbitrary perfusion units (APUs).
arm group label: High-level laser therapy
arm group type: Experimental
description: Real high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments)
arm group label: Sham High-level laser therapy
arm group type: Sham Comparator
description: Sham high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments)
intervention type: Radiation
intervention name: High-level laser therapy
description: Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area.
arm group label: High-level laser therapy
arm group label: Sham High-level laser therapy
other name: Nd:Yag laser
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Mélanie Morin, PT, PhD
role: Principal Investigator
affiliation: Université de Sherbrooke
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Université de Sherbrooke
investigator full name: Mélanie Morin
investigator title: Researcher and Associate Professor
mesh term: Vulvodynia
mesh term: Vulvar Vestibulitis
sharing ipd: No