<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/NCT04492176</url>
  </required_header>
  <id_info>
    <org_study_id>XijingH-PF-20190718</org_study_id>
    <nct_id>NCT04492176</nct_id>
  </id_info>
  <brief_title>A Clinical Clinical Observation of CO2 Fractional Laser in Female Vaginal Repair</brief_title>
  <official_title>A Clinical Clinical Observation of CO2 Fractional Laser in Female Vaginal Repair: A Non-randomized, Open, Inter-group and Self-controlled Trial Before and After Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xijing Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Vaginal atrophy is the most common indication in the treatment of vaginal rejuvenation.&#xD;
           Its main manifestation is vaginal relaxation syndrome, which may be the early symptom of&#xD;
           female pelvic floor dysfunction. It is a common gynecological physiological change in&#xD;
           women. Its clinical manifestations include vaginal wall relaxation, decreased&#xD;
           elasticity, poor dryness sensitivity, internal environment disorder, and so on. Vaginal&#xD;
           exhaust, often combined with urinary incontinence, pelvic organ prolapse, chronic pelvic&#xD;
           discomfort and other symptoms, seriously affecting patients'health and quality of sexual&#xD;
           life. At present, there are many treatments for vaginal relaxation,vaginal constriction&#xD;
           and laser therapy are the most effective and widely accepted treatments. Laser therapy&#xD;
           with small trauma and short repair time has attracted much attention.&#xD;
&#xD;
        2. CO2 fractional laser (Acupulse) stimulates fibroblasts to synthesize and secrete&#xD;
           collagen fibers, elastic fibers, reticular fibers and organic matrix through dot&#xD;
           exfoliation and thermal stimulation, thus thickening the vaginal wall and achieving&#xD;
           long-term vaginal tightening effect. The heat effect of CO2 laser can stimulate&#xD;
           vasodilation, increase blood flow, increase cell oxidation and nutrients, increase&#xD;
           mitochondrial ATP release, activate cell function, enhance vaginal mucosal secretion,&#xD;
           enhance secretion, normalize vaginal PH and bacterial flora, and then reduce the&#xD;
           probability of gynecological infection.&#xD;
&#xD;
        3. It has been reported that CO2 lattice laser can stimulate collagen synthesis and&#xD;
           rearrangement. It has also been reported that CO2 lattice laser may have important&#xD;
           clinical significance in improving the morphology and function of vaginal epithelial&#xD;
           cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Vaginal atrophy is the most common indication in the treatment of vaginal rejuvenation.&#xD;
           Its main manifestation is vaginal relaxation syndrome, which may be the early symptom of&#xD;
           female pelvic floor dysfunction. It is a common gynecological physiological change in&#xD;
           women. Its clinical manifestations include vaginal wall relaxation, decreased&#xD;
           elasticity, poor dryness sensitivity, internal environment disorder, and so on. Vaginal&#xD;
           exhaust, often combined with urinary incontinence, pelvic organ prolapse, chronic pelvic&#xD;
           discomfort and other symptoms, seriously affecting patients'health and quality of sexual&#xD;
           life. At present, there are many treatments for vaginal relaxation,vaginal constriction&#xD;
           and laser therapy are the most effective and widely accepted treatments. It should be&#xD;
           noted that patients with vaginal constriction need anti-scar training for a long time&#xD;
           after operation to prevent the effect of vaginal entrance narrowing and vaginal wall&#xD;
           scar formation on the quality of life of patients during the repair period. Therefore,&#xD;
           laser therapy with small trauma and short repair time has attracted much attention.&#xD;
&#xD;
        2. CO2 fractional laser (Acupulse) stimulates fibroblasts to synthesize and secrete&#xD;
           collagen fibers, elastic fibers, reticular fibers and organic matrix through dot&#xD;
           exfoliation and thermal stimulation, thus thickening the vaginal wall and achieving&#xD;
           long-term vaginal tightening effect. The heat effect of CO2 laser can stimulate&#xD;
           vasodilation, increase blood flow, increase cell oxidation and nutrients, increase&#xD;
           mitochondrial ATP release, activate cell function, enhance vaginal mucosal secretion,&#xD;
           enhance secretion, normalize vaginal Internal environment and bacterial flora, and then&#xD;
           reduce the probability of gynecological infection.&#xD;
&#xD;
        3. It has been reported that CO2 lattice laser can stimulate collagen synthesis and&#xD;
           rearrangement. It has also been reported that CO2 lattice laser may have important&#xD;
           clinical significance in improving the morphology and function of vaginal epithelial&#xD;
           cells. Our center has also passed the clinical observation ethical review of CO2 lattice&#xD;
           laser to improve female vaginal relaxation in 2016, and completed the clinical trial at&#xD;
           the end of 2017. The data further confirm that CO2 lattice laser can improve vaginal&#xD;
           relaxation and is significantly effective for stress urinary incontinence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>female sexual function FSFI score（Female Sexual Function Index ）</measure>
    <time_frame>Changes from preoperative to 1 year after initial treatment</time_frame>
    <description>Questionnaire content involving sexual activity, intercourse, sexual stimulation, sexual desire or sexual interest, sexual excitement or sexual arousal, evaluation of female sexual function, questionnaire score ≤ 26.55 is considered female sexual dysfunction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>urinary incontinence questionnaire short form assessment</measure>
    <time_frame>Changes from preoperative to 1 year after initial treatment</time_frame>
    <description>Evaluate urinary incontinence questionnaire short form assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VHIS score in vaginal environment</measure>
    <time_frame>Changes from preoperative to 1 year after initial treatment</time_frame>
    <description>Comprehensive evaluation of vaginal status by vulvar status, internal PH value, vaginal elasticity, guided endocrine secretion, and vaginal moistness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>vaginal pressure VTI data detection</measure>
    <time_frame>Changes from preoperative to 1 year after initial treatment</time_frame>
    <description>Evaluate vaginal pressure by VTI data detection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pelvic floor magnetic resonance MRI plain</measure>
    <time_frame>Changes from preoperative to 1 year after initial treatment</time_frame>
    <description>Measure tissue structures in the pelvis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>scantransvaginal ultrasound</measure>
    <time_frame>Changes from preoperative to 1 year after initial treatment</time_frame>
    <description>Measure the structures of the vagina</description>
  </primary_outcome>
  <primary_outcome>
    <measure>histopathological biopsy</measure>
    <time_frame>Changes before and 1month after treatment</time_frame>
    <description>5 cases were randomly selected for histopathological biopsy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction assessment</measure>
    <time_frame>Changes from preoperative to 1 year after initial treatment</time_frame>
    <description>Patient satisfaction: Very satisfied, satisfied, average, dissatisfied, very dissatisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS Pain Assessment(Immediately after Treatment)</measure>
    <time_frame>3 months</time_frame>
    <description>VAS pain scoring criteria (0-10 points): 0 points: no pain; less than 3 points: mild pain, can tolerate; 4 points 1-6 points: patients with pain and affect sleep, can still tolerate; 7 points-10 points : The patient has increasing pain, and the pain is intolerable</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Vaginal Atrophy</condition>
  <arm_group>
    <arm_group_label>CO2 fractional laser（ACUPULSE,Lumenis）</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>gradually withdrawn from inside to outside of vaginal. with CO2 fractional laser therapy ( hexagonal spot , 10-12.5m J/cm2 , density 5-15%，ACUPULSE,Lumenis) ,once a month for a total of 3 times .CO2 fractional laser stimulates fibroblasts to synthesize and secrete collagen fibers, elastic fibers, reticular fibers and organic matrix through dot exfoliation and thermal stimulation, thus thickening the vaginal wall and achieving long-term vaginal tightening effect. The heat effect of CO2 laser can stimulate vasodilation, increase blood flow, increase cell oxidation and nutrients, increase mitochondrial ATP release, activate cell function, enhance vaginal mucosal secretion, enhance secretion, normalize vaginal PH and bacterial flora, and then reduce the probability of gynecological infection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>before treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>the patient did not receive laser treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CO2 fractional laser（ACUPULSE,Lumenis）</intervention_name>
    <description>gradually withdrawn from inside to outside of vaginal. with Acupulse Femtouch mode therapy ( hexagonal spot , 10-12.5m J/cm2 , density 5-15%) ,once a month for a total of 3 times</description>
    <arm_group_label>CO2 fractional laser（ACUPULSE,Lumenis）</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Married women aged 25-75 with improvement needs;&#xD;
&#xD;
          -  Agree to participate in the experiment and sign the informed consent.&#xD;
&#xD;
          -  Female sexual dysfunction patients;&#xD;
&#xD;
          -  No other external treatment was performed before treatment at the lesion site.&#xD;
&#xD;
          -  VTI instrument was used for intravaginal pressure test to assess urinary incontinence&#xD;
             and vaginal senility caused by chronic muscle dysfunction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women;&#xD;
&#xD;
          -  suffering from severe mental disorders, psychological disorders, personality disorders&#xD;
             and major organ dysfunction;&#xD;
&#xD;
          -  Patients with severe hematological diseases, Sjogren's syndrome, systemic and&#xD;
             therapeutic site infections;&#xD;
&#xD;
          -  Patients who took high doses of anticoagulants or hormones within one month;&#xD;
&#xD;
          -  Laser allergy history, photosensitive reactor;&#xD;
&#xD;
          -  Women with acute vaginitis or cervicitis;&#xD;
&#xD;
          -  Pap smear positive patients;&#xD;
&#xD;
          -  Female HIV (HIV), HPV (papillary virus), HSV (herpes simplex virus) positive patients;&#xD;
&#xD;
          -  Use of antifungal drugs, vaginal administration, vaginal irrigation and female sprays&#xD;
             in the past 30 days&#xD;
&#xD;
          -  The condition of the visual field of laser surgery affected by ulceration and&#xD;
             infection of the skin lesion&#xD;
&#xD;
          -  Those who have undergone vaginal tightening surgery with other substances or means&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gang Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dermatology Derpartment of Xijing Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dermatology Derpartment of Xijing Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 4, 2019</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xijing Hospital</investigator_affiliation>
    <investigator_full_name>Gang Wang, MD</investigator_full_name>
    <investigator_title>chief of dermatology</investigator_title>
  </responsible_party>
  <keyword>Vaginal atrophy</keyword>
  <keyword>Vaginal relaxation</keyword>
  <keyword>stress urinary incontinence</keyword>
  <keyword>CO2 fractional laser</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrophy</mesh_term>
  </condition_browse>
  <!-- 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/NCT04492176
org study id: XijingH-PF-20190718
nct id: NCT04492176
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
1. Vaginal atrophy is the most common indication in the treatment of vaginal rejuvenation.
           Its main manifestation is vaginal relaxation syndrome, which may be the early symptom of
           female pelvic floor dysfunction. It is a common gynecological physiological change in
           women. Its clinical manifestations include vaginal wall relaxation, decreased
           elasticity, poor dryness sensitivity, internal environment disorder, and so on. Vaginal
           exhaust, often combined with urinary incontinence, pelvic organ prolapse, chronic pelvic
           discomfort and other symptoms, seriously affecting patients'health and quality of sexual
           life. At present, there are many treatments for vaginal relaxation,vaginal constriction
           and laser therapy are the most effective and widely accepted treatments. Laser therapy
           with small trauma and short repair time has attracted much attention.

        2. CO2 fractional laser (Acupulse) stimulates fibroblasts to synthesize and secrete
           collagen fibers, elastic fibers, reticular fibers and organic matrix through dot
           exfoliation and thermal stimulation, thus thickening the vaginal wall and achieving
           long-term vaginal tightening effect. The heat effect of CO2 laser can stimulate
           vasodilation, increase blood flow, increase cell oxidation and nutrients, increase
           mitochondrial ATP release, activate cell function, enhance vaginal mucosal secretion,
           enhance secretion, normalize vaginal PH and bacterial flora, and then reduce the
           probability of gynecological infection.

        3. It has been reported that CO2 lattice laser can stimulate collagen synthesis and
           rearrangement. It has also been reported that CO2 lattice laser may have important
           clinical significance in improving the morphology and function of vaginal epithelial
           cells.
1. Vaginal atrophy is the most common indication in the treatment of vaginal rejuvenation.
           Its main manifestation is vaginal relaxation syndrome, which may be the early symptom of
           female pelvic floor dysfunction. It is a common gynecological physiological change in
           women. Its clinical manifestations include vaginal wall relaxation, decreased
           elasticity, poor dryness sensitivity, internal environment disorder, and so on. Vaginal
           exhaust, often combined with urinary incontinence, pelvic organ prolapse, chronic pelvic
           discomfort and other symptoms, seriously affecting patients'health and quality of sexual
           life. At present, there are many treatments for vaginal relaxation,vaginal constriction
           and laser therapy are the most effective and widely accepted treatments. It should be
           noted that patients with vaginal constriction need anti-scar training for a long time
           after operation to prevent the effect of vaginal entrance narrowing and vaginal wall
           scar formation on the quality of life of patients during the repair period. Therefore,
           laser therapy with small trauma and short repair time has attracted much attention.

        2. CO2 fractional laser (Acupulse) stimulates fibroblasts to synthesize and secrete
           collagen fibers, elastic fibers, reticular fibers and organic matrix through dot
           exfoliation and thermal stimulation, thus thickening the vaginal wall and achieving
           long-term vaginal tightening effect. The heat effect of CO2 laser can stimulate
           vasodilation, increase blood flow, increase cell oxidation and nutrients, increase
           mitochondrial ATP release, activate cell function, enhance vaginal mucosal secretion,
           enhance secretion, normalize vaginal Internal environment and bacterial flora, and then
           reduce the probability of gynecological infection.

        3. It has been reported that CO2 lattice laser can stimulate collagen synthesis and
           rearrangement. It has also been reported that CO2 lattice laser may have important
           clinical significance in improving the morphology and function of vaginal epithelial
           cells. Our center has also passed the clinical observation ethical review of CO2 lattice
           laser to improve female vaginal relaxation in 2016, and completed the clinical trial at
           the end of 2017. The data further confirm that CO2 lattice laser can improve vaginal
           relaxation and is significantly effective for stress urinary incontinence.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: female sexual function FSFI score（Female Sexual Function Index ）
time frame: Changes from preoperative to 1 year after initial treatment
description: Questionnaire content involving sexual activity, intercourse, sexual stimulation, sexual desire or sexual interest, sexual excitement or sexual arousal, evaluation of female sexual function, questionnaire score ≤ 26.55 is considered female sexual dysfunction
measure: urinary incontinence questionnaire short form assessment
time frame: Changes from preoperative to 1 year after initial treatment
description: Evaluate urinary incontinence questionnaire short form assessment
measure: VHIS score in vaginal environment
time frame: Changes from preoperative to 1 year after initial treatment
description: Comprehensive evaluation of vaginal status by vulvar status, internal PH value, vaginal elasticity, guided endocrine secretion, and vaginal moistness
measure: vaginal pressure VTI data detection
time frame: Changes from preoperative to 1 year after initial treatment
description: Evaluate vaginal pressure by VTI data detection
measure: pelvic floor magnetic resonance MRI plain
time frame: Changes from preoperative to 1 year after initial treatment
description: Measure tissue structures in the pelvis
measure: scantransvaginal ultrasound
time frame: Changes from preoperative to 1 year after initial treatment
description: Measure the structures of the vagina
measure: histopathological biopsy
time frame: Changes before and 1month after treatment
description: 5 cases were randomly selected for histopathological biopsy
measure: patient satisfaction assessment
time frame: Changes from preoperative to 1 year after initial treatment
description: Patient satisfaction: Very satisfied, satisfied, average, dissatisfied, very dissatisfied
measure: VAS Pain Assessment(Immediately after Treatment)
time frame: 3 months
description: VAS pain scoring criteria (0-10 points): 0 points: no pain; less than 3 points: mild pain, can tolerate; 4 points 1-6 points: patients with pain and affect sleep, can still tolerate; 7 points-10 points : The patient has increasing pain, and the pain is intolerable
arm group label: CO2 fractional laser（ACUPULSE,Lumenis）
arm group type: Experimental
description: gradually withdrawn from inside to outside of vaginal. with CO2 fractional laser therapy ( hexagonal spot , 10-12.5m J/cm2 , density 5-15%，ACUPULSE,Lumenis) ,once a month for a total of 3 times .CO2 fractional laser stimulates fibroblasts to synthesize and secrete collagen fibers, elastic fibers, reticular fibers and organic matrix through dot exfoliation and thermal stimulation, thus thickening the vaginal wall and achieving long-term vaginal tightening effect. The heat effect of CO2 laser can stimulate vasodilation, increase blood flow, increase cell oxidation and nutrients, increase mitochondrial ATP release, activate cell function, enhance vaginal mucosal secretion, enhance secretion, normalize vaginal PH and bacterial flora, and then reduce the probability of gynecological infection.
arm group label: before treatment
arm group type: No Intervention
description: the patient did not receive laser treatment
intervention type: Device
intervention name: CO2 fractional laser（ACUPULSE,Lumenis）
description: gradually withdrawn from inside to outside of vaginal. with Acupulse Femtouch mode therapy ( hexagonal spot , 10-12.5m J/cm2 , density 5-15%) ,once a month for a total of 3 times
arm group label: CO2 fractional laser（ACUPULSE,Lumenis）
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gang Wang
role: Principal Investigator
affiliation: Dermatology Derpartment of Xijing Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xijing Hospital
investigator full name: Gang Wang, MD
investigator title: chief of dermatology
mesh term: Atrophy