Effect of Hybrid Laser 10600+1540 nm on GSM

Quanta System, S.p.A.30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Vaginal Atrophy Genitourinary Disease

Interventions

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.