Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause

Study Overview
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Brief Summary
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This multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid fractional 2940 nm and 1470 nm lasers for treatment of symptoms of Genitourinary Syndrome of Menopause.

Detailed Description
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Both 2940 nm Er:YAG (Erbium-doped yttrium aluminium garnet) and 1470 nm diode lasers are cleared by the Food and Drug Administration (FDA) for ablation, vaporization, coagulation of soft tissue and for skin resurfacing. Fractional delivery of laser is a well-established method that stimulates tissue remodeling in the dermis while leaving the surrounding tissue intact in order to decrease healing time. The layers of skin and vaginal mucosal tissue exhibit similarities that suggest the clinical results seen with skin resurfacing may be translated to the vaginal tissue. Improved vaginal tissue health may lead to improvement of symptoms of Genitourinary Syndrome of Menopause (GSM). This multi-centered, 18-month prospective clinical trial will evaluate the safety and long-term effectiveness of hybrid fractional 2940 nm and 1470 nm lasers (HFL) as an alternative non-surgical, non-hormonal treatment for symptoms of GSM.

Official Title
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Safety and Efficacy of Hybrid Fractional Laser Treatment for Symptoms of Genitourinary Syndrome of Menopause

Conditions
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Vaginal Atrophy, Sexual Dysfunction, Dyspareunia, Vaginal Dryness, Chronic UTI

Intervention / Treatment
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* Device: Hybrid Fractional Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy biological female aged between 40 to 70 years Is post-menopausal with a AND b OR c No menses for at least 12 months Follicle-stimulating hormone (FSH) level over 40mlU/mL Has had a bilateral oophorectomy at least 12 months ago with no hormone replacement Is experiencing at least two self-reported symptoms of GSM, such as Vaginal irritation in absence of infection Chronic burning sensation Chronic itching in the absence of infection Recurring urinary tract infections (UTIs) Vaginal dryness during sexual activity Pain during sexual activity (dyspareunia) Has been experiencing symptoms of GSM for greater than 3 months Is unable due to medical contraindication or unwilling to receive hormone-based vaginal therapy Normal and up-to-date pap smear if applicable Is sexually active (i.e. intravaginal intercourse) or has the potential and desire to be sexually active if symptoms of GSM improve Can read, understand and sign informed consent form Exclusion Criteria: Undiagnosed abnormal genital bleeding Has history of pelvic surgery or other energy-based vaginal therapy within 6 months prior to enrollment Previous use of topical estrogen therapy within the last 3 months Has used vaginal creams, moisturizers, lubricants or homeopathic preparations or received anticoagulants, antiplatelet, thrombolytic, vitamin E or anti-inflammatory within 2 weeks of treatment History of heart failure Has equal to or greater than stage III prolapse, according to pelvic organ prolapse quantification system (POP-Q) Has an active sexually transmitted infection (STI) Has signs or symptoms of vaginitis/vulvitis Has signs or symptoms of acute urinary tract infection (UTI) Has participated in any clinical trial involving an investigational drug or procedure within the past 30 days The investigator feels that for any reason the subject is not eligible to participate in the study

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid Fractional Laser<br>Hybrid fractional 2940 nm and 1470 nm laser treatment | Device: Hybrid Fractional Laser<br>* Consecutive and coincident fractional 2940 nm and 1470 nm lasers<br>* Other names: diVa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Vaginal Maturation Index (VMI) | An objective assessment of vaginal hormone response as well as overall hormonal environment by calculating a ratio of parabasal cells, intermediate cells, and superficial cells | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Histology | Change from baseline in epithelial thickness, collagen, elastin, vascularity, and fibroblast density. | 12 months | 
| Change from baseline in Vaginal Health Index Score (VHIS) | A quantitative assessment of vaginal health that evaluates vaginal elasticity, fluid volume, pH, epithelial integrity, and moisture on a scale of 1 to 5. | 12 months | 
| Change from baseline in Female Sexual Function Index (FSFI) | A multidimensional self-report instrument for assessment of female sexual function. | 12 months | 
| Change from baseline in Day-to-Day Impact of Vaginal Aging Questionnaire (DIVA) | A multidimensional self-report measure of the impact of vaginal symptoms on functioning and well-being in postmenopausal women. | 12 months | 
| Change from baseline in Clinical Photography | Change from baseline in the appearance of the treatment area. | 12 months |