<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/NCT02981654</url>
  </required_header>
  <id_info>
    <org_study_id>2092-15-SMC</org_study_id>
    <nct_id>NCT02981654</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Carbone Dioxide (CO2) Laser System in Treatment of Female Stress Urinary Incontinence.</brief_title>
  <acronym>CO2</acronym>
  <official_title>Prospective, Open-Label, Multi-Center, Non- Comparative Study to Assess the Safety and Efficacy of CO2 Laser System (FemiLiftTM) in the Treatment of Stress Urinary Incontinence (SUI) in Female Subjects.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Baruch Padeh Medical Center, Poriya</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaplan Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, open-label, multi-center, non-comparative study that will be conducted&#xD;
      on female subjects between 30 and 75 years of age, diagnosed with stress urinary incontinence&#xD;
      (SUI).&#xD;
&#xD;
      Following the screening period, including urodynamic assessment to confirm SUI, each subject&#xD;
      will undergo three FemiLiftTM treatment sessions, and will be followed up for a period of one&#xD;
      year. The main efficacy endpoint in this study is defined as significant improvement (score&#xD;
      of 6 or 7) in the urinary incontinence measured with PGI-I score at the 6 months visit.&#xD;
      Various subjective and objective measures of incontinence severity, quality of life, sexual&#xD;
      function and tissue effects will be performed at follow up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Improvement in SUI symptoms as measured by the following parameters:&#xD;
&#xD;
      Objective parameters:&#xD;
&#xD;
        -  Change from baseline in 3 days Urinary Diary - at 1, 2, 6 and 12 months:&#xD;
&#xD;
             -  Number of incontinence episodes per day&#xD;
&#xD;
             -  Number of pads used per day&#xD;
&#xD;
        -  Change from baseline in 1 hour pad test 1, 2, 6 and 12 months&#xD;
&#xD;
        -  Change from baseline as assessed with Vaginal Biopsy&#xD;
&#xD;
      Subjective parameters:&#xD;
&#xD;
        -  Patient Global Impression of Severity (PGI-S) - 4-point Likert scale - at screening, 1,&#xD;
           2, 6 and 12 months&#xD;
&#xD;
        -  Change from baseline in Pelvic Floor Distress Inventory Questionnaire (PFDI) - at 1, 2,&#xD;
           6 and 12 months&#xD;
&#xD;
        -  Change from baseline in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire&#xD;
           (PISQ) - at 1, 2, 6 and 12 months&#xD;
&#xD;
        -  Change from baseline in Pelvic Floor Impact Questionnaire (PFIQ) - at 1, 2, 6 and 12&#xD;
           months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success Rate - SUI Symptom Improvement</measure>
    <time_frame>6 months</time_frame>
    <description>Success rate - defined as an improvement in SUI symptoms as a score or 6 or 7 measured by the Patient Global Impression of Improvement (PGI-I) - 7-point Likert scale - at the 6 months visit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urinary Diary</measure>
    <time_frame>12 months</time_frame>
    <description>Change from baseline in 3 days Urinary Diary - at 1, 2, 6 and 12 months post first treatment:&#xD;
Number of incontinence episodes per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1 hour pad test</measure>
    <time_frame>12 months</time_frame>
    <description>Change from baseline in 1 hour pad test at 1, 2, 6 and 12 months post first treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaginal Biopsy</measure>
    <time_frame>12 months</time_frame>
    <description>Sample will be obtained from the vaginal mucosa 2 cm inside the introitus on the lateral vaginal wall.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PGI-S</measure>
    <time_frame>12 months</time_frame>
    <description>Change from baseline in Patient Global Impression of Severity (PGI-S) over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFDI</measure>
    <time_frame>12 months</time_frame>
    <description>Change from baseline in Pelvic Floor Distress Inventory Questionnaire (PFDI) over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PISQ</measure>
    <time_frame>12 months</time_frame>
    <description>Change from baseline in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFIQ</measure>
    <time_frame>12 months</time_frame>
    <description>Change from baseline in Pelvic Floor Impact Questionnaire (PFIQ) over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Endpoint assessed by the rate of serious device related adverse events</measure>
    <time_frame>12 months</time_frame>
    <description>The rate of serious device related adverse events reported during the study</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Female Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Femilift treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Alma Lasers Pixel carbon dioxide laser system delivers fractionated laser energy through a special lens that divides the energy into a 9 x 9 (81) matrix of 1 cm square area. The fractional laser rays cause thermal damage that reaches the vaginal sub - epithelium to stimulate the growth of new collagen.&#xD;
Intervention: FemiLift vaginal handpiece is inserted into the vagina, to deliver CO2 laser energy. The vaginal epithelium is covered by rotation of vaginal handpiece in 360 degrees, releasing laser energy at 6-8 points, and than withdrawn 1 cm each time to perform the same process, to cover the the total vaginal length.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Alma Lasers Pixel carbon dioxide laser system</intervention_name>
    <description>The vaginal handpiece sheath is lubricated with baby oil. Set the initial energy level (startup set up recommendations: High mode, 40 millijoule/pixel; according to the patient reaction you can increase up to 120 max. Pulse mode or Repeat mode). The handpiece is inserted as distally as possible, with the laser energy's window oriented to the 12:00 o'clock position. There are position markings on the handpiece. Trigger a laser pulse by pressing the footswitch. Shoot the laser and rotate the probe by one hour at a time. When you reach the 12:00 o'clock position again, withdrawal the headpiece back by one centimeter and repeat the rotational treatment process.</description>
    <arm_group_label>Femilift treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females between 30 and 75 years of age&#xD;
&#xD;
          -  Provided written Informed Consent&#xD;
&#xD;
          -  Patients with mild to moderate stress urinary incontinence (SUI) [according to the&#xD;
             severity index developed by Sandvik]&#xD;
&#xD;
          -  Patients with mixed urinary incontinence, while the predominant symptoms are stress&#xD;
             related, may also be enrolled&#xD;
&#xD;
          -  Normal Papanicolaou smear (up to 1 year prior to screening)&#xD;
&#xD;
          -  Negative urine culture&#xD;
&#xD;
          -  Vaginal canal, introitus and vestibule free of injuries and bleeding&#xD;
&#xD;
          -  Positive urinary stress test (Urine leakage is demonstrated while the patient is&#xD;
             examined with full bladder in lithotomy position, and asked to perform 3 strong&#xD;
             coughs).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  Planned pregnancy within the next year&#xD;
&#xD;
          -  Severe prolapse (POP&gt;= grade 3)&#xD;
&#xD;
          -  Use of photosensitive drugs&#xD;
&#xD;
          -  Injury or/and active infection in the treatment area&#xD;
&#xD;
          -  Active vaginal infection&#xD;
&#xD;
          -  human papillomavirus/herpes simplex virus&#xD;
&#xD;
          -  Undiagnosed vaginal bleeding&#xD;
&#xD;
          -  Urge or overflow incontinence&#xD;
&#xD;
          -  Patients who are on antidepressants, or α-adrenergic and anticholinergic medications&#xD;
&#xD;
          -  Patients with immune system diseases.&#xD;
&#xD;
          -  Patients with allergic reaction to laser.&#xD;
&#xD;
          -  Patient under treatment with photosensitivity side effects medication.&#xD;
&#xD;
          -  Obese women (BMI &gt;30)&#xD;
&#xD;
          -  Patient unable to follow post treatment instructions.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Menachem Alcalay, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head, Urogynecology Unit, Chaim Sheba Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yair Leopld</last_name>
    <phone>972-54-4847271</phone>
    <email>Yair.Leopold@almasurgical.com</email>
  </overall_contact>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>October 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>December 4, 2016</last_update_submitted>
  <last_update_submitted_qc>December 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</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>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</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/NCT02981654
org study id: 2092-15-SMC
nct id: NCT02981654
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This is a prospective, open-label, multi-center, non-comparative study that will be conducted
      on female subjects between 30 and 75 years of age, diagnosed with stress urinary incontinence
      (SUI).

      Following the screening period, including urodynamic assessment to confirm SUI, each subject
      will undergo three FemiLiftTM treatment sessions, and will be followed up for a period of one
      year. The main efficacy endpoint in this study is defined as significant improvement (score
      of 6 or 7) in the urinary incontinence measured with PGI-I score at the 6 months visit.
      Various subjective and objective measures of incontinence severity, quality of life, sexual
      function and tissue effects will be performed at follow up.
Improvement in SUI symptoms as measured by the following parameters:

      Objective parameters:

        -  Change from baseline in 3 days Urinary Diary - at 1, 2, 6 and 12 months:

             -  Number of incontinence episodes per day

             -  Number of pads used per day

        -  Change from baseline in 1 hour pad test 1, 2, 6 and 12 months

        -  Change from baseline as assessed with Vaginal Biopsy

      Subjective parameters:

        -  Patient Global Impression of Severity (PGI-S) - 4-point Likert scale - at screening, 1,
           2, 6 and 12 months

        -  Change from baseline in Pelvic Floor Distress Inventory Questionnaire (PFDI) - at 1, 2,
           6 and 12 months

        -  Change from baseline in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire
           (PISQ) - at 1, 2, 6 and 12 months

        -  Change from baseline in Pelvic Floor Impact Questionnaire (PFIQ) - at 1, 2, 6 and 12
           months
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Success Rate - SUI Symptom Improvement
time frame: 6 months
description: Success rate - defined as an improvement in SUI symptoms as a score or 6 or 7 measured by the Patient Global Impression of Improvement (PGI-I) - 7-point Likert scale - at the 6 months visit
measure: Urinary Diary
time frame: 12 months
description: Change from baseline in 3 days Urinary Diary - at 1, 2, 6 and 12 months post first treatment:
Number of incontinence episodes per day
measure: 1 hour pad test
time frame: 12 months
description: Change from baseline in 1 hour pad test at 1, 2, 6 and 12 months post first treatment
measure: Vaginal Biopsy
time frame: 12 months
description: Sample will be obtained from the vaginal mucosa 2 cm inside the introitus on the lateral vaginal wall.
measure: PGI-S
time frame: 12 months
description: Change from baseline in Patient Global Impression of Severity (PGI-S) over time
measure: PFDI
time frame: 12 months
description: Change from baseline in Pelvic Floor Distress Inventory Questionnaire (PFDI) over time
measure: PISQ
time frame: 12 months
description: Change from baseline in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) over time
measure: PFIQ
time frame: 12 months
description: Change from baseline in Pelvic Floor Impact Questionnaire (PFIQ) over time
measure: Safety Endpoint assessed by the rate of serious device related adverse events
time frame: 12 months
description: The rate of serious device related adverse events reported during the study
arm group label: Femilift treatment
arm group type: Experimental
description: The Alma Lasers Pixel carbon dioxide laser system delivers fractionated laser energy through a special lens that divides the energy into a 9 x 9 (81) matrix of 1 cm square area. The fractional laser rays cause thermal damage that reaches the vaginal sub - epithelium to stimulate the growth of new collagen.
Intervention: FemiLift vaginal handpiece is inserted into the vagina, to deliver CO2 laser energy. The vaginal epithelium is covered by rotation of vaginal handpiece in 360 degrees, releasing laser energy at 6-8 points, and than withdrawn 1 cm each time to perform the same process, to cover the the total vaginal length.
intervention type: Device
intervention name: Alma Lasers Pixel carbon dioxide laser system
description: The vaginal handpiece sheath is lubricated with baby oil. Set the initial energy level (startup set up recommendations: High mode, 40 millijoule/pixel; according to the patient reaction you can increase up to 120 max. Pulse mode or Repeat mode). The handpiece is inserted as distally as possible, with the laser energy's window oriented to the 12:00 o'clock position. There are position markings on the handpiece. Trigger a laser pulse by pressing the footswitch. Shoot the laser and rotate the probe by one hour at a time. When you reach the 12:00 o'clock position again, withdrawal the headpiece back by one centimeter and repeat the rotational treatment process.
arm group label: Femilift treatment
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Menachem Alcalay, MD
role: Principal Investigator
affiliation: Head, Urogynecology Unit, Chaim Sheba Medical Center
last name: Yair Leopld
phone: 972-54-4847271
email: Yair.Leopold@almasurgical.com
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
sharing ipd: No