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Safety and Efficacy of Carbone Dioxide (CO2) Laser System in Treatment of Female Stress Urinary Incontinence. (CO2)

Primary Purpose

Female Stress Urinary Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Alma Lasers Pixel carbon dioxide laser system
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Stress Urinary Incontinence

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Females between 30 and 75 years of age
  • Provided written Informed Consent
  • Patients with mild to moderate stress urinary incontinence (SUI) [according to the severity index developed by Sandvik]
  • Patients with mixed urinary incontinence, while the predominant symptoms are stress related, may also be enrolled
  • Normal Papanicolaou smear (up to 1 year prior to screening)
  • Negative urine culture
  • Vaginal canal, introitus and vestibule free of injuries and bleeding
  • Positive urinary stress test (Urine leakage is demonstrated while the patient is examined with full bladder in lithotomy position, and asked to perform 3 strong coughs).

Exclusion Criteria:

  • Positive pregnancy test
  • Planned pregnancy within the next year
  • Severe prolapse (POP>= grade 3)
  • Use of photosensitive drugs
  • Injury or/and active infection in the treatment area
  • Active vaginal infection
  • human papillomavirus/herpes simplex virus
  • Undiagnosed vaginal bleeding
  • Urge or overflow incontinence
  • Patients who are on antidepressants, or α-adrenergic and anticholinergic medications
  • Patients with immune system diseases.
  • Patients with allergic reaction to laser.
  • Patient under treatment with photosensitivity side effects medication.
  • Obese women (BMI >30)
  • Patient unable to follow post treatment instructions.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Femilift treatment

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Success Rate - SUI Symptom Improvement
    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

    Secondary Outcome Measures

    Urinary Diary
    Change from baseline in 3 days Urinary Diary - at 1, 2, 6 and 12 months post first treatment: Number of incontinence episodes per day
    1 hour pad test
    Change from baseline in 1 hour pad test at 1, 2, 6 and 12 months post first treatment
    Vaginal Biopsy
    Sample will be obtained from the vaginal mucosa 2 cm inside the introitus on the lateral vaginal wall.
    PGI-S
    Change from baseline in Patient Global Impression of Severity (PGI-S) over time
    PFDI
    Change from baseline in Pelvic Floor Distress Inventory Questionnaire (PFDI) over time
    PISQ
    Change from baseline in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) over time
    PFIQ
    Change from baseline in Pelvic Floor Impact Questionnaire (PFIQ) over time
    Safety Endpoint assessed by the rate of serious device related adverse events
    The rate of serious device related adverse events reported during the study

    Full Information

    First Posted
    October 30, 2016
    Last Updated
    December 4, 2016
    Sponsor
    Sheba Medical Center
    Collaborators
    The Baruch Padeh Medical Center, Poriya, Kaplan Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02981654
    Brief Title
    Safety and Efficacy of Carbone Dioxide (CO2) Laser System in Treatment of Female Stress Urinary Incontinence.
    Acronym
    CO2
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    May 2017 (Anticipated)
    Study Completion Date
    May 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sheba Medical Center
    Collaborators
    The Baruch Padeh Medical Center, Poriya, Kaplan Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Female Stress Urinary Incontinence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Femilift treatment
    Arm Type
    Experimental
    Arm 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(s)
    Alma Lasers Pixel carbon dioxide laser system
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Success Rate - SUI Symptom Improvement
    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
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Urinary Diary
    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
    Time Frame
    12 months
    Title
    1 hour pad test
    Description
    Change from baseline in 1 hour pad test at 1, 2, 6 and 12 months post first treatment
    Time Frame
    12 months
    Title
    Vaginal Biopsy
    Description
    Sample will be obtained from the vaginal mucosa 2 cm inside the introitus on the lateral vaginal wall.
    Time Frame
    12 months
    Title
    PGI-S
    Description
    Change from baseline in Patient Global Impression of Severity (PGI-S) over time
    Time Frame
    12 months
    Title
    PFDI
    Description
    Change from baseline in Pelvic Floor Distress Inventory Questionnaire (PFDI) over time
    Time Frame
    12 months
    Title
    PISQ
    Description
    Change from baseline in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) over time
    Time Frame
    12 months
    Title
    PFIQ
    Description
    Change from baseline in Pelvic Floor Impact Questionnaire (PFIQ) over time
    Time Frame
    12 months
    Title
    Safety Endpoint assessed by the rate of serious device related adverse events
    Description
    The rate of serious device related adverse events reported during the study
    Time Frame
    12 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Females between 30 and 75 years of age Provided written Informed Consent Patients with mild to moderate stress urinary incontinence (SUI) [according to the severity index developed by Sandvik] Patients with mixed urinary incontinence, while the predominant symptoms are stress related, may also be enrolled Normal Papanicolaou smear (up to 1 year prior to screening) Negative urine culture Vaginal canal, introitus and vestibule free of injuries and bleeding Positive urinary stress test (Urine leakage is demonstrated while the patient is examined with full bladder in lithotomy position, and asked to perform 3 strong coughs). Exclusion Criteria: Positive pregnancy test Planned pregnancy within the next year Severe prolapse (POP>= grade 3) Use of photosensitive drugs Injury or/and active infection in the treatment area Active vaginal infection human papillomavirus/herpes simplex virus Undiagnosed vaginal bleeding Urge or overflow incontinence Patients who are on antidepressants, or α-adrenergic and anticholinergic medications Patients with immune system diseases. Patients with allergic reaction to laser. Patient under treatment with photosensitivity side effects medication. Obese women (BMI >30) Patient unable to follow post treatment instructions.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yair Leopld
    Phone
    972-54-4847271
    Email
    Yair.Leopold@almasurgical.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Menachem Alcalay, MD
    Organizational Affiliation
    Head, Urogynecology Unit, Chaim Sheba Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Safety and Efficacy of Carbone Dioxide (CO2) Laser System in Treatment of Female Stress Urinary Incontinence.

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