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/NCT06000202</url>
    </required_header>
    <id_info>
      <org_study_id>689852</org_study_id>
      <nct_id>NCT06000202</nct_id>
    </id_info>
    <brief_title>Elastographic Improvement of Vaginal Atrophy Treated by Erbium Yag Laser</brief_title>
    <official_title>Elastographic Improvement of Vaginal Atrophy Treated by Er:YAG Laser</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul University - Cerrahpasa (IUC)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul University - Cerrahpasa (IUC)</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 study is a randomized controlled sham applied study. Its aim is to evaluate the efficacy&#xD;
        of Er:YAG laser for the treatment of atrophic vaginitis in postmenopausal women.&#xD;
  &#xD;
        In this study, demonstration of the efficacy of Er:YAG laser for the treatment of atrophic&#xD;
        vaginitis in postmenopausal women is intended with Maturation Index (MI), vaginal pH&#xD;
        measurement, Female Sexual Function Index (FSFI), Vaginal Health Index (VaHI), Visual&#xD;
        Analogue Scale (VAS) and ultrasonographic elastography&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In the postmenopausal period, especially due to estrogen deficiency, vaginal atrophy occurs&#xD;
        in the vulvo-vagina, lower urinary tract, pelvic floor muscles and endopelvic fascia. Vaginal&#xD;
        dryness secondary to atrophy in genital organs, pain and tenderness especially during sexual&#xD;
        intercourse, and decreased genital elasticity are the most common symptoms and signs during&#xD;
        the postmenopausal period. With regard to the urinary system, frequent urination, feeling of&#xD;
        urgency, recurrent urinary tract infections, organ prolapses-urethrocele, cystocele, urethral&#xD;
        prolapse and stress or urge type urinary incontinence could be seen.These signs and symptoms&#xD;
        were recognized in 2014 by the International Society for the Study of Women's Sexual Health&#xD;
        (ISSWSH) and the North American Menopause Society (NAMS) under the main title OF&#xD;
        &quot;genito-urinary syndrome of menopause&quot; (GSM). During the postmenopausal period, a detailed&#xD;
        history should be taken, a complete physical examination should be performed, and various&#xD;
        tests should be performed for the evaluation of GSM.&#xD;
  &#xD;
        Laser is a treatment option for the genitourinary symptoms that could occur at the&#xD;
        postmenopausal period. Laser can be applied to vulva by giving an external beam, or it can be&#xD;
        applied intravaginally or directly to the urethra using vaginal and urethral cannula.&#xD;
  &#xD;
        The smooth mode application of the Er:YAG laser ensures that the laser beam retains the heat&#xD;
        it gives without ablation and penetrates deeper into the tissue. After laser application,&#xD;
        thermomechanical and thermochemical effects occur in the tissue, respectively. It provides&#xD;
        controlled thermal energy and causes shrinkage of the collagen fibrils in the vaginal&#xD;
        epithelium and lamina propria. It also induces neocollagenesis, elastogenesis and&#xD;
        neoangiogenesis by temperature change. With minimum damage to the peripheral tissue, the&#xD;
        viable cells in the target tissue reacts to this temperature change by expressing heat shock&#xD;
        proteins (HSP). Then, HSP increases the levels of transforming growth factor-beta, fibroblast&#xD;
        growth factor, epidermal growth factor, platelet-derived growth factor, vascular epithelial&#xD;
        growth factor which induce neocollagenesis and neoangiogenesis. Therefore, the thermal energy&#xD;
        stored in the vaginal wall induces proliferation of the epithelium which is rich in glycogen,&#xD;
        neovascularization and collagen production in the lamina propria.&#xD;
  &#xD;
        In this study, evaluation and demonstration of the efficacy of Er:YAG laser for the treatment&#xD;
        of atrophic vaginitis in postmenopausal women is intended with Maturation Index (MI), vaginal&#xD;
        pH measurement, Female Sexual Function Index (FSFI), Vaginal Health Index (VaHI), Visual&#xD;
        Analogue Scale (VAS) and ultrasonographic elastography.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 11, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>
      <masking_description>The participant doesn't know if she receives the sham or laser therapy.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Efficacy: Rate of improvement in vaginal atrophy</measure>
      <time_frame>6 months</time_frame>
      <description>Evaluation of the efficacy and safety of vaginal atrophy by using ultrasonographic Elastography</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Efficacy:Rate of improvement in sexual function</measure>
      <time_frame>6 months</time_frame>
      <description>Evaluation of dyspareunia by Female Sexual Function Index</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Efficacy: Rate of improvement in vaginal atrophy</measure>
      <time_frame>6 months</time_frame>
      <description>Evaluation of Maturation Index</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Efficacy: Rate of improvement in vaginal atrophy</measure>
      <time_frame>6 months</time_frame>
      <description>Evaluation of Vaginal Health Index</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Efficacy: Rate of improvement in pain</measure>
      <time_frame>6 months</time_frame>
      <description>Evaluated by Visual Analogue Scale</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Safety:Incidence and severity of device related Adverse Events</measure>
      <time_frame>6 months</time_frame>
      <description>Incidence and severity of device related Adverse Events (i.e., infections, edema, superficial burns, wound dehiscence)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Vaginal Atrophy</condition>
    <condition>Dyspareunia</condition>
    <condition>Laser</condition>
    <condition>Genitourinary Syndrome of Menopause (GSM)</condition>
    <condition>Er:YAG Laser</condition>
    <arm_group>
      <arm_group_label>Laser Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Non-ablative thermal-only Er:YAG laser (Fotona Dynamis) treatment using R11 and PS03 handpieces</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham Arm</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>The same procedure is applied but with a sham handpiece.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Fotona Dynamis Er:YAG Laser System</intervention_name>
      <description>The patient receives 2940 nm Er:YAG Laser (XS Dynamis, Fotona, Slovenia) at intervals of 21 days. She receives 3 sessions, in total. Each session consists of application of PS03 handpiece intravaginal with spot size of 7 mm, fluence of 10 j/cm2, frequency of 1.6 Hz and 4-7 pulses per point and 6 passes followed by R11 handpiece intravaginal with spot size of 7 mm, fluence of 10 j/cm2, frequency of 1.6 Hz and 4-7 pulses per point and 3 passes.</description>
      <arm_group_label>Laser Arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sham</intervention_name>
      <description>Er:YAG laser is applied with sham handpiece.</description>
      <arm_group_label>Sham Arm</arm_group_label>
      <other_name>Placebo</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Postmenopausal women with vaginal atrophy symptoms&#xD;
  &#xD;
            -  Adult Female, 18 years of age or older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a history of previous vaginal operation,&#xD;
  &#xD;
            -  Patients with pelvic organ prolapse&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>18 years and older postmenopausal women</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cemal Tamer Erel, Prof.</last_name>
      <role>Study Director</role>
      <affiliation>Istanbul University - Cerrahpasa (IUC)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cemal Tamer Erel, Prof.</last_name>
      <phone>+905322946022</phone>
      <email>ctamererel@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Istanbul University-Cerrahpaşa</name>
        <address>
          <city>Istanbul</city>
          <zip>34098</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cemal Tamer Erel, Prof.</last_name>
        <phone>+905322946022</phone>
        <email>ctamererel@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Elif Bayraktar, MD</last_name>
        <phone>+905426863492</phone>
        <email>elibayraktar@hotmail.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Istanbul University-Cerrahpasa</name>
        <address>
          <city>Istanbul</city>
          <zip>34450</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cemal Tamer Erel, Prof.</last_name>
        <phone>+905322946022</phone>
        <email>ctamererel@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
      <investigator_full_name>Cemal Tamer Erel</investigator_full_name>
      <investigator_title>Prof.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dyspareunia</mesh_term>
      <mesh_term>Atrophy</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The results will be available after the completion of the study for a year.</ipd_description>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>It will be available after the completion of the study for a year.</ipd_time_frame>
    </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/NCT06000202
  org study id: 689852
  nct id: NCT06000202
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is a randomized controlled sham applied study. Its aim is to evaluate the efficacy
        of Er:YAG laser for the treatment of atrophic vaginitis in postmenopausal women.
  
        In this study, demonstration of the efficacy of Er:YAG laser for the treatment of atrophic
        vaginitis in postmenopausal women is intended with Maturation Index (MI), vaginal pH
        measurement, Female Sexual Function Index (FSFI), Vaginal Health Index (VaHI), Visual
        Analogue Scale (VAS) and ultrasonographic elastography
  In the postmenopausal period, especially due to estrogen deficiency, vaginal atrophy occurs
        in the vulvo-vagina, lower urinary tract, pelvic floor muscles and endopelvic fascia. Vaginal
        dryness secondary to atrophy in genital organs, pain and tenderness especially during sexual
        intercourse, and decreased genital elasticity are the most common symptoms and signs during
        the postmenopausal period. With regard to the urinary system, frequent urination, feeling of
        urgency, recurrent urinary tract infections, organ prolapses-urethrocele, cystocele, urethral
        prolapse and stress or urge type urinary incontinence could be seen.These signs and symptoms
        were recognized in 2014 by the International Society for the Study of Women's Sexual Health
        (ISSWSH) and the North American Menopause Society (NAMS) under the main title OF
        "genito-urinary syndrome of menopause" (GSM). During the postmenopausal period, a detailed
        history should be taken, a complete physical examination should be performed, and various
        tests should be performed for the evaluation of GSM.
  
        Laser is a treatment option for the genitourinary symptoms that could occur at the
        postmenopausal period. Laser can be applied to vulva by giving an external beam, or it can be
        applied intravaginally or directly to the urethra using vaginal and urethral cannula.
  
        The smooth mode application of the Er:YAG laser ensures that the laser beam retains the heat
        it gives without ablation and penetrates deeper into the tissue. After laser application,
        thermomechanical and thermochemical effects occur in the tissue, respectively. It provides
        controlled thermal energy and causes shrinkage of the collagen fibrils in the vaginal
        epithelium and lamina propria. It also induces neocollagenesis, elastogenesis and
        neoangiogenesis by temperature change. With minimum damage to the peripheral tissue, the
        viable cells in the target tissue reacts to this temperature change by expressing heat shock
        proteins (HSP). Then, HSP increases the levels of transforming growth factor-beta, fibroblast
        growth factor, epidermal growth factor, platelet-derived growth factor, vascular epithelial
        growth factor which induce neocollagenesis and neoangiogenesis. Therefore, the thermal energy
        stored in the vaginal wall induces proliferation of the epithelium which is rich in glycogen,
        neovascularization and collagen production in the lamina propria.
  
        In this study, evaluation and demonstration of the efficacy of Er:YAG laser for the treatment
        of atrophic vaginitis in postmenopausal women is intended with Maturation Index (MI), vaginal
        pH measurement, Female Sexual Function Index (FSFI), Vaginal Health Index (VaHI), Visual
        Analogue Scale (VAS) and ultrasonographic elastography.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: The participant doesn't know if she receives the sham or laser therapy.
  measure: Efficacy: Rate of improvement in vaginal atrophy
  time frame: 6 months
  description: Evaluation of the efficacy and safety of vaginal atrophy by using ultrasonographic Elastography
  measure: Efficacy:Rate of improvement in sexual function
  time frame: 6 months
  description: Evaluation of dyspareunia by Female Sexual Function Index
  measure: Efficacy: Rate of improvement in vaginal atrophy
  time frame: 6 months
  description: Evaluation of Maturation Index
  measure: Efficacy: Rate of improvement in vaginal atrophy
  time frame: 6 months
  description: Evaluation of Vaginal Health Index
  measure: Efficacy: Rate of improvement in pain
  time frame: 6 months
  description: Evaluated by Visual Analogue Scale
  measure: Safety:Incidence and severity of device related Adverse Events
  time frame: 6 months
  description: Incidence and severity of device related Adverse Events (i.e., infections, edema, superficial burns, wound dehiscence)
  arm group label: Laser Arm
  arm group type: Experimental
  description: Non-ablative thermal-only Er:YAG laser (Fotona Dynamis) treatment using R11 and PS03 handpieces
  arm group label: Sham Arm
  arm group type: Sham Comparator
  description: The same procedure is applied but with a sham handpiece.
  intervention type: Device
  intervention name: Fotona Dynamis Er:YAG Laser System
  description: The patient receives 2940 nm Er:YAG Laser (XS Dynamis, Fotona, Slovenia) at intervals of 21 days. She receives 3 sessions, in total. Each session consists of application of PS03 handpiece intravaginal with spot size of 7 mm, fluence of 10 j/cm2, frequency of 1.6 Hz and 4-7 pulses per point and 6 passes followed by R11 handpiece intravaginal with spot size of 7 mm, fluence of 10 j/cm2, frequency of 1.6 Hz and 4-7 pulses per point and 3 passes.
  arm group label: Laser Arm
  intervention type: Device
  intervention name: Sham
  description: Er:YAG laser is applied with sham handpiece.
  arm group label: Sham Arm
  other name: Placebo
  criteria: 
  gender: Female
  gender based: Yes
  gender description: 18 years and older postmenopausal women
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Cemal Tamer Erel, Prof.
  role: Study Director
  affiliation: Istanbul University - Cerrahpasa (IUC)
  last name: Cemal Tamer Erel, Prof.
  phone: +905322946022
  email: ctamererel@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul University - Cerrahpasa (IUC)
  investigator full name: Cemal Tamer Erel
  investigator title: Prof.
  mesh term: Dyspareunia
  mesh term: Atrophy
  sharing ipd: Yes
  ipd description: The results will be available after the completion of the study for a year.
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: It will be available after the completion of the study for a year.