Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause

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.

Inclusion Criteria:

1. Healthy biological female aged between 40 to 70 years

2. Is post-menopausal with a AND b OR c

1. No menses for at least 12 months

2. Follicle-stimulating hormone (FSH) level over 40mlU/mL

3. Has had a bilateral oophorectomy at least 12 months ago with no hormone
replacement

3. Is experiencing at least two self-reported symptoms of GSM, such as

1. Vaginal irritation in absence of infection

2. Chronic burning sensation

3. Chronic itching in the absence of infection

4. Recurring urinary tract infections (UTIs)

5. Vaginal dryness during sexual activity

6. Pain during sexual activity (dyspareunia)

4. Has been experiencing symptoms of GSM for greater than 3 months

5. Is unable due to medical contraindication or unwilling to receive hormone-based
vaginal therapy

6. Normal and up-to-date pap smear if applicable

7. Is sexually active (i.e. intravaginal intercourse) or has the potential and desire to
be sexually active if symptoms of GSM improve

8. Can read, understand and sign informed consent form

Exclusion Criteria:

1. Undiagnosed abnormal genital bleeding

2. Has history of pelvic surgery or other energy-based vaginal therapy within 6 months
prior to enrollment

3. Previous use of topical estrogen therapy within the last 3 months

4. Has used vaginal creams, moisturizers, lubricants or homeopathic preparations or
received anticoagulants, antiplatelet, thrombolytic, vitamin E or anti-inflammatory
within 2 weeks of treatment

5. History of heart failure

6. Has equal to or greater than stage III prolapse, according to pelvic organ prolapse
quantification system (POP-Q)

7. Has an active sexually transmitted infection (STI)

8. Has signs or symptoms of vaginitis/vulvitis

9. Has signs or symptoms of acute urinary tract infection (UTI)

10. Has participated in any clinical trial involving an investigational drug or procedure
within the past 30 days

11. The investigator feels that for any reason the subject is not eligible to participate
in the study