<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/NCT03288883</url>
  </required_header>
  <id_info>
    <org_study_id>RCTGSM</org_study_id>
    <nct_id>NCT03288883</nct_id>
  </id_info>
  <brief_title>RCT of Laser Therapy for GSM</brief_title>
  <official_title>Fractional Microablative CO2-laser Versus Photothermal Non-ablative Erbium:YAG-laser for the Management of Genitourinary Syndrome of Menopause: A Non-inferiority, Single-blind Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College Hospital NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alexandra Hospital, Athens, Greece</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King's College Hospital NHS Trust</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the current study is to assess whether the CO2-laser results in superior&#xD;
      alleviation of GSM symptoms compare to Er:YAG-laser. Specifically, we will compare objective&#xD;
      and subjective measurements of symptoms and clinical signs of GSM, between groups of&#xD;
      postmenopausal women with GSM receiving treatment with CO2-laser or Er:YAG-laser.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Genitourinary Syndrome of Menopause (GSM) is the new terminology for &quot;vulvovaginal (VVA)&quot;.&#xD;
      Although women may present with some or all of the clinical signs and symptoms, the most&#xD;
      common symptom of VVA/GSM is vaginal dryness. Vaginal dryness appears early at menopause with&#xD;
      a subsequent increase of prevalence as postmenopausal years' progresses and is associated&#xD;
      with rising occurrence of lower urinary tract symptoms (LUTS).&#xD;
&#xD;
      The therapeutic management of GSM includes lubricants and moisturizers as a first line&#xD;
      therapy and low-dose vaginal estrogens as a second one, especially for women with a history&#xD;
      of estrogen dependent cancer. However, lubricants and moisturizers can only be used for&#xD;
      symptoms relief during sexual intercourse. They do not restore the local pathophysiology and&#xD;
      they are inefficacious when LUTS are present. However, the quality of evidence is low or&#xD;
      very-low when estrogens efficacy is compared to placebo, while the risk to the endometrial&#xD;
      thickness with sustained vaginal estrogen use is not clear.&#xD;
&#xD;
      Recently, intravaginal laser therapy has been proposed for the management of GSM. There are&#xD;
      currently two lasers available. All available studies consistently suggest that both lasers&#xD;
      (CO2-laser and Er:YAG-laser) are safe and have a high efficacy on alleviating vaginal dryness&#xD;
      and dyspareunia, as well as restoring the local pathophysiology. Additionally, data regarding&#xD;
      CO2-laser indicate LUTS improvement, as well as sexual function-satisfaction and quality of&#xD;
      women's life. Relevant published data are not available for the Er:YAG-laser. Moreover, there&#xD;
      is lack of studies comparing the 2 laser-technologies for the management of postmenopausal&#xD;
      women with GSM.&#xD;
&#xD;
      The aim of the current study is to assess whether the CO2-laser results in superior&#xD;
      alleviation of GSM symptoms compare to Er:YAG-laser. Specifically, we will compare objective&#xD;
      and subjective measurements of symptoms and clinical signs of GSM, between groups of&#xD;
      postmenopausal women with GSM receiving treatment with CO2-laser or Er:YAG-laser.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">February 11, 2021</completion_date>
  <primary_completion_date type="Actual">February 11, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dryness - 10cm visual analogue scale</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dyspareunia- 10cm visual analogue scale</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Itching- 10cm visual analogue scale</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Burning- 10cm visual analogue scale</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dysuria- 10cm visual analogue scale</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency- 10cm visual analogue scale,</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Urgency-10cm visual analogue scale</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary incontinence- 10cm visual analogue scale</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall sexual satisfaction- Female sexual function index</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency- 3 day voiding diary</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Urgency- 3 day voiding diary,</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary incontinence- 3 day voiding diary</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall sexual satisfaction- 10cm visual analogue scale</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall sexual satisfaction- frequency of sexual intercourse,</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life- patients global impression of improvement questionnaire</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life- day to day impact of vaginal ageing questionnaire</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life- kings health questionnaire</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global impression of improvement- day to day impact of vaginal ageing questionnaire</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global impression of improvement- patients global impression of improvement questionnaire</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global impression of improvement- kings health questionnaire</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaginal health index score- 5 components, elasticity, epithelial integrity, pH, moisture and fluid volume</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaginal maturation value- vaginal smear stained with papanicolaou technique and VMI value is evaluated by defining the percentage of superficial, intermediate and paranasal epithelial cells on smear.</measure>
    <time_frame>1 year</time_frame>
    <description>VMV = ((1x%superficial)+(0.5x%intermediate)+0xparabasal))</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Genitourinary Syndrome of Menopause</condition>
  <arm_group>
    <arm_group_label>Fractional Microablative CO2-laser</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Photothermal Non-ablative Erbium:YAG-laser</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Photothermal Non-ablative Erbium:YAG-laser</intervention_name>
    <description>Laser treatment of the vagina for GSM</description>
    <arm_group_label>Photothermal Non-ablative Erbium:YAG-laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fractional Microablative CO2-laser</intervention_name>
    <description>Laser treatment of the vagina for GSM</description>
    <arm_group_label>Fractional Microablative CO2-laser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Dryness and dyspareunia with moderate to severe intensity&#xD;
&#xD;
          2. Vaginal Health Index &lt;15&#xD;
&#xD;
          3. Absence of menstruation for at least 12 months&#xD;
&#xD;
          4. Recent Negative Pap-smear test (For women over 65 years old a negative pap smear test&#xD;
             up to the age of 65).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Not willing to abstain from vaginal intercourse for one week following the&#xD;
             laser-therapy&#xD;
&#xD;
          2. Use of hormonal therapy within 6 months prior to study inclusion (systemic or local)&#xD;
&#xD;
          3. Acute urinary tract infections (UTIs)&#xD;
&#xD;
          4. History of a genital fistula, a thin recto-vaginal septum as determined by the&#xD;
             investigator or history of a fourth-degree laceration during screening physical exam&#xD;
             (e.g., perineal body)&#xD;
&#xD;
          5. Active sexually transmitted disease upon vaginal exam (as determined by the&#xD;
             investigator) that precludes treatment or any other vaginal infection&#xD;
&#xD;
          6. Active or history of genital herpes&#xD;
&#xD;
          7. Prolapse stages &gt; II (according to the POP-Q system)&#xD;
&#xD;
          8. History of radiotherapy for cervical or uterine cancer&#xD;
&#xD;
          9. Medical condition that may interfere with participants' compliance to the protocol&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Urogynaecology Department, King's College Hospital</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>February 11, 2021</last_update_submitted>
  <last_update_submitted_qc>February 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</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/NCT03288883
org study id: RCTGSM
nct id: NCT03288883
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of the current study is to assess whether the CO2-laser results in superior
      alleviation of GSM symptoms compare to Er:YAG-laser. Specifically, we will compare objective
      and subjective measurements of symptoms and clinical signs of GSM, between groups of
      postmenopausal women with GSM receiving treatment with CO2-laser or Er:YAG-laser.
Genitourinary Syndrome of Menopause (GSM) is the new terminology for "vulvovaginal (VVA)".
      Although women may present with some or all of the clinical signs and symptoms, the most
      common symptom of VVA/GSM is vaginal dryness. Vaginal dryness appears early at menopause with
      a subsequent increase of prevalence as postmenopausal years' progresses and is associated
      with rising occurrence of lower urinary tract symptoms (LUTS).

      The therapeutic management of GSM includes lubricants and moisturizers as a first line
      therapy and low-dose vaginal estrogens as a second one, especially for women with a history
      of estrogen dependent cancer. However, lubricants and moisturizers can only be used for
      symptoms relief during sexual intercourse. They do not restore the local pathophysiology and
      they are inefficacious when LUTS are present. However, the quality of evidence is low or
      very-low when estrogens efficacy is compared to placebo, while the risk to the endometrial
      thickness with sustained vaginal estrogen use is not clear.

      Recently, intravaginal laser therapy has been proposed for the management of GSM. There are
      currently two lasers available. All available studies consistently suggest that both lasers
      (CO2-laser and Er:YAG-laser) are safe and have a high efficacy on alleviating vaginal dryness
      and dyspareunia, as well as restoring the local pathophysiology. Additionally, data regarding
      CO2-laser indicate LUTS improvement, as well as sexual function-satisfaction and quality of
      women's life. Relevant published data are not available for the Er:YAG-laser. Moreover, there
      is lack of studies comparing the 2 laser-technologies for the management of postmenopausal
      women with GSM.

      The aim of the current study is to assess whether the CO2-laser results in superior
      alleviation of GSM symptoms compare to Er:YAG-laser. Specifically, we will compare objective
      and subjective measurements of symptoms and clinical signs of GSM, between groups of
      postmenopausal women with GSM receiving treatment with CO2-laser or Er:YAG-laser.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Dryness - 10cm visual analogue scale
time frame: 1 year
measure: Dyspareunia- 10cm visual analogue scale
time frame: 1 year
measure: Itching- 10cm visual analogue scale
time frame: 1 year
measure: Burning- 10cm visual analogue scale
time frame: 1 year
measure: Dysuria- 10cm visual analogue scale
time frame: 1 year
measure: Frequency- 10cm visual analogue scale,
time frame: 1 year
measure: Urgency-10cm visual analogue scale
time frame: 1 year
measure: Urinary incontinence- 10cm visual analogue scale
time frame: 1 year
measure: Overall sexual satisfaction- Female sexual function index
time frame: 1 year
measure: Frequency- 3 day voiding diary
time frame: 1 year
measure: Urgency- 3 day voiding diary,
time frame: 1 year
measure: Urinary incontinence- 3 day voiding diary
time frame: 1 year
measure: Overall sexual satisfaction- 10cm visual analogue scale
time frame: 1 year
measure: Overall sexual satisfaction- frequency of sexual intercourse,
time frame: 1 year
measure: Quality of life- patients global impression of improvement questionnaire
time frame: 1 year
measure: Quality of life- day to day impact of vaginal ageing questionnaire
time frame: 1 year
measure: Quality of life- kings health questionnaire
time frame: 1 year
measure: Global impression of improvement- day to day impact of vaginal ageing questionnaire
time frame: 1 year
measure: Global impression of improvement- patients global impression of improvement questionnaire
time frame: 1 year
measure: Global impression of improvement- kings health questionnaire
time frame: 1 year
measure: Vaginal health index score- 5 components, elasticity, epithelial integrity, pH, moisture and fluid volume
time frame: 1 year
measure: Vaginal maturation value- vaginal smear stained with papanicolaou technique and VMI value is evaluated by defining the percentage of superficial, intermediate and paranasal epithelial cells on smear.
time frame: 1 year
description: VMV = ((1x%superficial)+(0.5x%intermediate)+0xparabasal))
arm group label: Fractional Microablative CO2-laser
arm group type: Active Comparator
arm group label: Photothermal Non-ablative Erbium:YAG-laser
arm group type: Active Comparator
intervention type: Device
intervention name: Photothermal Non-ablative Erbium:YAG-laser
description: Laser treatment of the vagina for GSM
arm group label: Photothermal Non-ablative Erbium:YAG-laser
intervention type: Device
intervention name: Fractional Microablative CO2-laser
description: Laser treatment of the vagina for GSM
arm group label: Fractional Microablative CO2-laser
criteria: 
gender: Female
gender based: Yes
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Syndrome
sharing ipd: No