Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause

Sexual Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03178825
• Other study ID #: DIVACIP002
• Status: Completed
• Phase: N/A
• Start date: May 19, 2017
• Est. completion date: February 25, 2020

Study information

• Verified date: August 2020
• Source: Sciton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 25, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Chronic UTI
• Dyspareunia
• Sexual Dysfunction
• Vaginal Atrophy
• Vaginal Dryness

Intervention

Device:
• Hybrid Fractional Laser
Consecutive and coincident fractional 2940 nm and 1470 nm lasers

Locations

Country	Name	City	State
United States	Carolinas Healthcare System	Charlotte	North Carolina
United States	Women's Pelvic Health Institute	Los Gatos	California
United States	Louisiana State University	New Orleans	Louisiana
United States	The Female Pelvic Medicine Institute of Virginia	North Chesterfield	Virginia
United States	Coyle Institute	Pensacola	Florida
United States	Woodlands Gynecology & Aesthetics	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sciton

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in Histology	Change from baseline in epithelial thickness, collagen, elastin, vascularity, and fibroblast density.	12 months
Secondary	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
Secondary	Change from baseline in Female Sexual Function Index (FSFI)	A multidimensional self-report instrument for assessment of female sexual function.	12 months
Secondary	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
Secondary	Change from baseline in Clinical Photography	Change from baseline in the appearance of the treatment area.	12 months