Effect of Hybrid Laser 10600+1540 nm on GSM

Study Overview
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Brief Summary
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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: 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. 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. To assess the Patient's Global Impression of Improvement (PGI) with the laser treatment For the GSM symptoms For the urinary symptoms and UI To assess the patient's satisfaction with the laser treatment. For the GSM symptoms For the urinary symptoms and UI.

Official Title
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Effect of Hybrid Laser 10600+1540 nm on Vaginal Atrophy-genitourinary Syndrome of the Menopause

Conditions
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Vaginal Atrophy, Genitourinary Disease

Intervention / Treatment
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* Device: Youlaser MT Group 2
* Device: Youlaser MT Group 1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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% To have any of the urinary symptoms: urgency, frequency, nocturia and urinary incontinence as symptoms of GSM Women able to understand , accept and signed the Informed Consent. Women with adequate physical and mental ability to understand and complete the questionnaires of quality of life and with cooperative attitude. Exclusion Criteria: VMV 50-64% (moderate) 65-100% (high estrogenic effect on the vaginal epithelium) Impossibility of introducing the laser device History or other energy-based vaginal therapy within 6 months prior to enrollment. Being on hormone replacement therapy to relieve menopausal symptoms 3 months before the study. Being on regular and effective topical estrogen therapy within the last 3 months. Being on concomitant anticoagulants therapy . Patients suffering of epileptic attacks and immunosuppressive diseases. Daily and effective use of moisturizers, lubricants or probiotics. Previous pelvic radiotherapy or brachytherapy Gynecologic or rectal cancer less than 5 years ago Breast cancer with antiestrogenic therapy Bladder emptying dysfunction. Women operated on UI. Subjects undergoing conservative supervised treatment, such as pelvic floor rehabilitation exercises. Genital prolapse grade III or higher, according to the simplified POPQ classification. Being on effective pharmacological treatment for overactive bladder. Taking diuretics. Patients with neurological diseases (Multiple Sclerosis, spinal cord injury, stroke, Parkinson's) Insulin-dependent diabetes mellitus (IDDM) or non-dependent insulin poorly controlled. Body Mass Index (BMI) > 40 kg/m2 Active urinary tract infection Hematuria. Women who present active or recurrent genital herpes. Undiagnosed metrorrhagia Abnormal last cervical cytology Developmental disability, cognitive impairment and/or serious mental health illness. Language barrier. Women who refuse to participate in the study.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active treatment arm<br>Youlaser MT: sequential 10600+1540 nm with vaginal (2 passes) and intritus (1 pass) treatment | Device: Youlaser MT Group 1<br>* 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.<br>|
| Sham Comparator: Control arm<br>Youlaser MT: no laser emission with vaginal (2 passes) and intritus (1 pass) treatment | Device: Youlaser MT Group 2<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrophic vaginal epithelium change | 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. | 3 months and 9 months post laser treatments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment area success for GSM #1 | Change to vaginal pH<5 | 3 months and 9 months post laser treatments | 
| Treatment area success for GSM #2 | 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). | 3 months and 9 months post laser treatments | 
| Treatment area success for Urinary incontinence #1 | 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. | 3 months and 9 months post laser treatments | 
| Treatment area success for Urinary incontinence #2 | Change in Sandvick test score from moderate to mild incontinence, or from mild to nil incontinence. | 3 months and 9 months post laser treatments | 
| Treatment area success for Urinary incontinence #3 | Decrease in the GSM urinary symptoms for dysuria and nocturia on VAS sclae 0-10 | 3 months and 9 months post laser treatments | 
| Patient Global Impression | Score in the Patient Global Impression of Improvement, as better and much better. | 3 months and 9 months post laser treatments | 
| Patient Satisfaction | Score in the degree of patient satisfaction, as satisfied and very satisfied. | 3 months and 9 months post laser treatments | 
| Safety evaluation | Each of the following safety outcome variables recorded across study duration will be assessed Pain rating during and after laser treatment. Frequence and severity of potential adverse effects. | 61 days (at each treatment) |