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Effect of Hybrid Laser 10600+1540 nm on GSM

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ClinicalTrials.gov Identifier: NCT03956563
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Quanta System, S.p.A.

Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 20, 2019
Last Update Posted Date May 20, 2019
Actual Study Start Date  ICMJE May 15, 2019
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2019)
Atrophic vaginal epithelium change [ Time Frame: 3 months and 9 months post laser treatments ]
The primary efficacy outcome measure in this study is to obtain on the atrophic vaginal epithelium at 3 months after the last laser treatment, values going from absent/low estrogenization (0-49%) to moderate or high estrogenization (50-64%) measured with VMV. The results will be compared between the treatment and the control arm.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2019)
  • Treatment area success for GSM #1 [ Time Frame: 3 months and 9 months post laser treatments ]
    Change to vaginal pH<5
  • Treatment area success for GSM #2 [ Time Frame: 3 months and 9 months post laser treatments ]
    Decrease in the GSM symptoms on VAS scale 0-10. vaginal dryness, burning, itching, and dyspareunia,dysuria (0: complete absence of symptoms, 10: worst possible symptoms).
  • Treatment area success for Urinary incontinence #1 [ Time Frame: 3 months and 9 months post laser treatments ]
    Change in ICIQ-SF score from moderate to mild incontinence, or from mild to nil incontinence. Improve the quality of life related to incontinence by decreasing the score in the interference with everydays life question.
  • Treatment area success for Urinary incontinence #2 [ Time Frame: 3 months and 9 months post laser treatments ]
    Change in Sandvick test score from moderate to mild incontinence, or from mild to nil incontinence.
  • Treatment area success for Urinary incontinence #3 [ Time Frame: 3 months and 9 months post laser treatments ]
    Decrease in the GSM urinary symptoms for dysuria and nocturia on VAS sclae 0-10
  • Patient Global Impression [ Time Frame: 3 months and 9 months post laser treatments ]
    Score in the Patient Global Impression of Improvement, as better and much better.
  • Patient Satisfaction [ Time Frame: 3 months and 9 months post laser treatments ]
    Score in the degree of patient satisfaction, as satisfied and very satisfied.
  • Safety evaluation [ Time Frame: 61 days (at each treatment) ]
    Each of the following safety outcome variables recorded across study duration will be assessed
    1. Pain rating during and after laser treatment.
    2. Frequence and severity of potential adverse effects.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Hybrid Laser 10600+1540 nm on GSM
Official Title  ICMJE Effect of Hybrid Laser 10600+1540 nm on Vaginal Atrophy-genitourinary Syndrome of the Menopause
Brief Summary

The primary objective of the study is to clinically confirm, by comparison with a control group, the performance of the 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 3 months after the last laser treatment.

The secondary objectives are:

  1. Confirm the performance of 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 9 months post-laser treatment, and compare it with the results at 3 months.
  2. Evaluate the improvement of the GSM urinary symptoms and urinary incontinence (UI) and their impact on the Quality of Life, at each timepoint after the first laser treatment.
  3. To assess the Patient's Global Impression of Improvement (PGI) with the laser treatment

    • For the GSM symptoms
    • For the urinary symptoms and UI
  4. To assess the patient's satisfaction with the laser treatment.

    • For the GSM symptoms
    • For the urinary symptoms and UI.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Vaginal Atrophy
  • Genitourinary Disease
Intervention  ICMJE
  • Device: Youlaser MT Group 2

    Youlaser MT is a laser device including two laser sources emitting at 10600 nm (CO2) and 1540 nm (Ga-As) intended to be used for gynaecological applications.

    Each patient in the control arm will receive 3 simulated laser treatments every 30 days.

    A placebo consists in a sham device laser that simulates the acoustic signal even if it does not deliver any laser radiation to the subject.

  • Device: Youlaser MT Group 1

    Youlaser MT is a laser device including two laser sources emitting at 10600 nm (CO2) and 1540 nm (Ga-As) intended to be used for gynaecological applications.

    Each patient in the active arm will receive 3 laser treatments with the laser: one treatment administration every 30 days.

Study Arms  ICMJE
  • Active Comparator: Active treatment arm
    Youlaser MT: sequential 10600+1540 nm with vaginal (2 passes) and intritus (1 pass) treatment
    Intervention: Device: Youlaser MT Group 1
  • Sham Comparator: Control arm
    Youlaser MT: no laser emission with vaginal (2 passes) and intritus (1 pass) treatment
    Intervention: Device: Youlaser MT Group 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 17, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 15, 2020
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Menopausal women (defined as ³1 year without menstruation until 65 years of age and no more than 10 years within the menopause) with at least 1 GSM symptom (vaginal dryness, burning, itching or dyspareunia ) Atrophic vaginal epithelium measured with the VMV values of 0-49%
  2. To have any of the urinary symptoms: urgency, frequency, nocturia and urinary incontinence as symptoms of GSM
  3. Women able to understand , accept and signed the Informed Consent.
  4. Women with adequate physical and mental ability to understand and complete the questionnaires of quality of life and with cooperative attitude.

Exclusion Criteria:

  1. VMV 50-64% (moderate) 65-100% (high estrogenic effect on the vaginal epithelium)
  2. Impossibility of introducing the laser device
  3. History or other energy-based vaginal therapy within 6 months prior to enrollment.
  4. Being on hormone replacement therapy to relieve menopausal symptoms 3 months before the study.
  5. Being on regular and effective topical estrogen therapy within the last 3 months.
  6. Being on concomitant anticoagulants therapy .
  7. Patients suffering of epileptic attacks and immunosuppressive diseases.
  8. Daily and effective use of moisturizers, lubricants or probiotics.
  9. Previous pelvic radiotherapy or brachytherapy
  10. Gynecologic or rectal cancer less than 5 years ago
  11. Breast cancer with antiestrogenic therapy
  12. Bladder emptying dysfunction.
  13. Women operated on UI.
  14. Subjects undergoing conservative supervised treatment, such as pelvic floor rehabilitation exercises.
  15. Genital prolapse grade III or higher, according to the simplified POPQ classification.
  16. Being on effective pharmacological treatment for overactive bladder.
  17. Taking diuretics.
  18. Patients with neurological diseases (Multiple Sclerosis, spinal cord injury, stroke, Parkinson's)
  19. Insulin-dependent diabetes mellitus (IDDM) or non-dependent insulin poorly controlled.
  20. Body Mass Index (BMI) > 40 kg/m2
  21. Active urinary tract infection
  22. Hematuria.
  23. Women who present active or recurrent genital herpes.
  24. Undiagnosed metrorrhagia
  25. Abnormal last cervical cytology
  26. Developmental disability, cognitive impairment and/or serious mental health illness.
  27. Language barrier.
  28. Women who refuse to participate in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Juan Salinas Peña, MD +34 34 977 310 300 jrsalinas2@gmail.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03956563
Other Study ID Numbers  ICMJE YLMT_VAG
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Quanta System, S.p.A.
Study Sponsor  ICMJE Quanta System, S.p.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Quanta System, S.p.A.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP