Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause

NCT ID: NCT03178825

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-19
• Study Completion Date: 2020-02-25

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hybrid Fractional Laser

Hybrid fractional 2940 nm and 1470 nm laser treatment

Group Type: EXPERIMENTAL

Hybrid Fractional Laser

Intervention Type: DEVICE

Consecutive and coincident fractional 2940 nm and 1470 nm lasers

Interventions

Hybrid Fractional Laser

Consecutive and coincident fractional 2940 nm and 1470 nm lasers

Intervention Type: DEVICE

Other Intervention Names

diVa

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sciton

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathan Guerette, MD

Role: PRINCIPAL_INVESTIGATOR

The Female Pelvic Institute of Virginia

Locations

Women's Pelvic Health Institute

Los Gatos, California, United States

Coyle Institute

Pensacola, Florida, United States

Louisiana State University

New Orleans, Louisiana, United States

Carolinas Healthcare System

Charlotte, North Carolina, United States

Woodlands Gynecology & Aesthetics

The Woodlands, Texas, United States

The Female Pelvic Medicine Institute of Virginia

North Chesterfield, Virginia, United States

Countries

United States

Other Identifiers

DIVACIP002

Identifier Type: -

Identifier Source: org_study_id