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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid Fractional Laser | Experimental | Hybrid fractional 2940 nm and 1470 nm laser treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid Fractional Laser | Device | Consecutive and coincident fractional 2940 nm and 1470 nm lasers |
|
| 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 |
| 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) |
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Inclusion Criteria:
Healthy biological female aged between 40 to 70 years
Is post-menopausal with a AND b OR c
Is experiencing at least two self-reported symptoms of GSM, such as
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:
Postmenopausal Females
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| Name | Affiliation | Role |
|---|---|---|
| Nathan Guerette, MD | The Female Pelvic Institute of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Pelvic Health Institute | Los Gatos | California | 95032 | United States | ||
| Coyle Institute |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| D004414 | Dyspareunia |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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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 |
| Pensacola |
| Florida |
| 32514 |
| United States |
| Louisiana State University | New Orleans | Louisiana | 70112 | United States |
| Carolinas Healthcare System | Charlotte | North Carolina | 28207 | United States |
| Woodlands Gynecology & Aesthetics | The Woodlands | Texas | 77384 | United States |
| The Female Pelvic Medicine Institute of Virginia | North Chesterfield | Virginia | 23235 | United States |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |