xml: <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/NCT06007027</url>
    </required_header>
    <id_info>
      <org_study_id>VagLaser</org_study_id>
      <nct_id>NCT06007027</nct_id>
    </id_info>
    <brief_title>Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors</brief_title>
    <official_title>Vaginal Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors - A Randomized, Blinded, Placebo-controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Aarhus</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Aarhus</source>
    <oversight_info>
      <has_dmc>Yes</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 project will be based on three studies over a period on three years. The first study is&#xD;
        a dose response study that includes 30 breast cancer survivors. They will receive a total of&#xD;
        5 laser treatments with 4-6 weeks intervals The second study is a double-blind randomized&#xD;
        controlled trial, that includes 60 breast cancer survivors. 30 of those will receive active&#xD;
        intervention and 30 will receive placebo laser treatment and act as controls. Based on the&#xD;
        results of the dose response study, a treatment consists of three to five laser treatments&#xD;
        every 3 weeks. The third and last study is a one-year follow-up on study two. The conditions&#xD;
        are evaluated before and after each treatment by questionnaires, vaginal fluid pH values,&#xD;
        punch biopsies and vaginal and urine microbiome. The studies is conducted at the Department&#xD;
        of Obstetrics and Gynaecology at Randers Regional Hospital in collaboration with Department&#xD;
        of Obstetrics and Gynaecology and Department of Oncology at Aarhus University Hospital.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">March 1, 2024</start_date>
    <completion_date type="Anticipated">July 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 30, 2025</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Vaginal dryness</measure>
      <time_frame>Symptom data is collected at baseline visit and one month after the last treatment</time_frame>
      <description>Participant are asked to complete the 10-cm visual analog scale (VAS) ranging for 0 to 10, with higher score indicating worse vaginal dryness.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in vaginal pain, itching and soreness</measure>
      <time_frame>Symptom data is collected at baseline visit and one month after the last treatment</time_frame>
      <description>Evaluated with visual analog scale for vaginal pain, itching, soreness. 10-cm visual analog scale (VAS) ranging for 0 to 10, with higher score indicating worse symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Female Sexual Function Index</measure>
      <time_frame>Symptom data is collected at baseline visit and one month after the last treatment</time_frame>
      <description>Sexual function parameters; desire, arousal, lubrication, orgasm, satisfaction and pain. Range 2-36, the threshold of 26.55 indicates sexual dysfunction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sexual complaint screener - women</measure>
      <time_frame>Symptom data is collected at baseline visit and one month after the last treatment</time_frame>
      <description>Addressing all domains of sexual dysfunction. Range 0-60, higher score indicate increased symptom severity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urogenital Distress Inventory</measure>
      <time_frame>Symptom data is collected at baseline visit and one month after the last treatment</time_frame>
      <description>For urinary symptoms; irritative symptoms, obstructive/discomfort and stress symptoms. Range 0-18, higher score indicate higher disability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>International Consultation on Incontinence Questionnaire Female Urinary Tract Symptoms Sex</measure>
      <time_frame>Symptom data is collected at baseline visit and one month after the last treatment</time_frame>
      <description>Evaluation of female sexual matters associated with their lower urinary tract symptoms. Range 0-14, higher values indicating increased symptom severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vaginal health index</measure>
      <time_frame>Vaginal health index is evaluated at baseline visit and one month after the last treatment</time_frame>
      <description>subjective scoring of moisture, fluid volume, epithelial integrity and elasticity and objective scoring of pH. Range 5-25, higher scores indicate better health</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vaginal biopsy</measure>
      <time_frame>Vaginal biopsy is collected at baseline visit and one month after the last treatment</time_frame>
      <description>The biopsy of 4*4 mm is taken from the lateralt vaginal wall, 2-3 cm from inotroitus. Afterwards fixated i formalin and the processed for light microsopy by a specialized gynaecological pathologist reporting on the changes in the histology of vaginal epithel and lamina propria.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vaginal and urinary microbiota</measure>
      <time_frame>Vaginal and urine microbiota are collected at baseline visit and one month after the last treatment</time_frame>
      <description>One polyester swap (FLOQSwab) is used to sample mid-vagina for microbial analysis and immediately been placed at - 80 °C until further processing. Urine is collected in a 50 mL collection tube using the clean catch method for women. Afterwards aliquoted into 10 mL fractions and immediately been placed at - 80 °C until further processing.&#xD;
  DNA is isolated from samples using standard DNA isolation kits and microbiota composition determined using 16S rRNA gene sequencing. Microbiota composition is compared between groups and over time based on alpha- and beta-diversity measures, as well as changes in relative abundances of individual bacteria.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Genitourinary Syndrome of Menopause</condition>
    <arm_group>
      <arm_group_label>Active laser group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the active laser group, participants are treated intravaginally with the fractional microablative CO2 laser system (SmartXIDE2V2LR, MonaLisa Touch, DEKA, Florence, Italy), using the following setting; dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μs and the smart stack parameter from 2 to 3. At the level of the vaginal introitus, the dot power decreases to 20 Watt.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham laser group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>In the sham laser group, participants are treated intravaginally with the fractional microablative CO2 laser system (SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy), using the following setting; dot power 0,5 watt, dwell time 100 μs, dot spacing 2000 μs and the smart stack parameter from 1 to 1</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy</intervention_name>
      <description>The laser probe is gently inserted up to the top of the vagina, and subsequently withdrawn and rotated in order to deliver a complete treatment of the vaginal wall.</description>
      <arm_group_label>Active laser group</arm_group_label>
      <arm_group_label>Sham laser group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Breast cancer survivor in endocrine therapy&#xD;
  &#xD;
            -  Symptomatic genitourinary symdrom of menopause with vaginal discomfort and/or&#xD;
               dyspareunia&#xD;
  &#xD;
            -  Able to read and understand Danish&#xD;
  &#xD;
            -  Able to give written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pelvic organ prolapse ≥ stage 2 according to the Pelvic Organ Prolapse Quantification&#xD;
               staging system&#xD;
  &#xD;
            -  Use of non-hormonal/hormonal vaginal therapies (1 and 12 months prior to the baseline&#xD;
               visit, respectively)&#xD;
  &#xD;
            -  Use of Chemotherapy (6 months prior to the baseline visit)&#xD;
  &#xD;
            -  Acute urinary tract infection or active genital infection&#xD;
  &#xD;
            -  History of vaginal reconstructive surgery&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sine Jacobsen, MD</last_name>
      <email>sinjac@rm.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Pinar Bor</last_name>
      <phone>78421069</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Obstetrics and Gynaecology, Randers Regional Hospital</name>
        <address>
          <city>Randers</city>
          <zip>8930</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <contact>
        <last_name>Sine Jacobsen</last_name>
        <email>sinjac@rm.dk</email>
      </contact>
      <contact_backup>
        <phone>+4578421069</phone>
      </contact_backup>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>laser</keyword>
    <keyword>mamma cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06007027
  org study id: VagLaser
  nct id: NCT06007027
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This project will be based on three studies over a period on three years. The first study is
        a dose response study that includes 30 breast cancer survivors. They will receive a total of
        5 laser treatments with 4-6 weeks intervals The second study is a double-blind randomized
        controlled trial, that includes 60 breast cancer survivors. 30 of those will receive active
        intervention and 30 will receive placebo laser treatment and act as controls. Based on the
        results of the dose response study, a treatment consists of three to five laser treatments
        every 3 weeks. The third and last study is a one-year follow-up on study two. The conditions
        are evaluated before and after each treatment by questionnaires, vaginal fluid pH values,
        punch biopsies and vaginal and urine microbiome. The studies is conducted at the Department
        of Obstetrics and Gynaecology at Randers Regional Hospital in collaboration with Department
        of Obstetrics and Gynaecology and Department of Oncology at Aarhus University Hospital.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Vaginal dryness
  time frame: Symptom data is collected at baseline visit and one month after the last treatment
  description: Participant are asked to complete the 10-cm visual analog scale (VAS) ranging for 0 to 10, with higher score indicating worse vaginal dryness.
  measure: Change in vaginal pain, itching and soreness
  time frame: Symptom data is collected at baseline visit and one month after the last treatment
  description: Evaluated with visual analog scale for vaginal pain, itching, soreness. 10-cm visual analog scale (VAS) ranging for 0 to 10, with higher score indicating worse symptoms.
  measure: Female Sexual Function Index
  time frame: Symptom data is collected at baseline visit and one month after the last treatment
  description: Sexual function parameters; desire, arousal, lubrication, orgasm, satisfaction and pain. Range 2-36, the threshold of 26.55 indicates sexual dysfunction
  measure: Sexual complaint screener - women
  time frame: Symptom data is collected at baseline visit and one month after the last treatment
  description: Addressing all domains of sexual dysfunction. Range 0-60, higher score indicate increased symptom severity
  measure: Urogenital Distress Inventory
  time frame: Symptom data is collected at baseline visit and one month after the last treatment
  description: For urinary symptoms; irritative symptoms, obstructive/discomfort and stress symptoms. Range 0-18, higher score indicate higher disability
  measure: International Consultation on Incontinence Questionnaire Female Urinary Tract Symptoms Sex
  time frame: Symptom data is collected at baseline visit and one month after the last treatment
  description: Evaluation of female sexual matters associated with their lower urinary tract symptoms. Range 0-14, higher values indicating increased symptom severity.
  measure: Vaginal health index
  time frame: Vaginal health index is evaluated at baseline visit and one month after the last treatment
  description: subjective scoring of moisture, fluid volume, epithelial integrity and elasticity and objective scoring of pH. Range 5-25, higher scores indicate better health
  measure: Vaginal biopsy
  time frame: Vaginal biopsy is collected at baseline visit and one month after the last treatment
  description: The biopsy of 4*4 mm is taken from the lateralt vaginal wall, 2-3 cm from inotroitus. Afterwards fixated i formalin and the processed for light microsopy by a specialized gynaecological pathologist reporting on the changes in the histology of vaginal epithel and lamina propria.
  measure: Vaginal and urinary microbiota
  time frame: Vaginal and urine microbiota are collected at baseline visit and one month after the last treatment
  description: One polyester swap (FLOQSwab) is used to sample mid-vagina for microbial analysis and immediately been placed at - 80 °C until further processing. Urine is collected in a 50 mL collection tube using the clean catch method for women. Afterwards aliquoted into 10 mL fractions and immediately been placed at - 80 °C until further processing.
  DNA is isolated from samples using standard DNA isolation kits and microbiota composition determined using 16S rRNA gene sequencing. Microbiota composition is compared between groups and over time based on alpha- and beta-diversity measures, as well as changes in relative abundances of individual bacteria.
  arm group label: Active laser group
  arm group type: Experimental
  description: In the active laser group, participants are treated intravaginally with the fractional microablative CO2 laser system (SmartXIDE2V2LR, MonaLisa Touch, DEKA, Florence, Italy), using the following setting; dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μs and the smart stack parameter from 2 to 3. At the level of the vaginal introitus, the dot power decreases to 20 Watt.
  arm group label: Sham laser group
  arm group type: Sham Comparator
  description: In the sham laser group, participants are treated intravaginally with the fractional microablative CO2 laser system (SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy), using the following setting; dot power 0,5 watt, dwell time 100 μs, dot spacing 2000 μs and the smart stack parameter from 1 to 1
  intervention type: Device
  intervention name: SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy
  description: The laser probe is gently inserted up to the top of the vagina, and subsequently withdrawn and rotated in order to deliver a complete treatment of the vaginal wall.
  arm group label: Active laser group
  arm group label: Sham laser group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Sine Jacobsen, MD
  email: sinjac@rm.dk
  last name: Pinar Bor
  phone: 78421069
  facility: 
  contact: 
  contact backup: 
  country: Denmark
  responsible party type: Sponsor
  mesh term: Syndrome
  sharing ipd: Undecided