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Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause

Sponsor
Sciton (Industry)
Overall Status
Completed
CT.gov ID
NCT03178825
Collaborator
(none)
60
Enrollment
6
Locations
1
Arm
33.2
Actual Duration (Months)
10
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hybrid Fractional Laser
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Hybrid Fractional Laser Treatment for Symptoms of Genitourinary Syndrome of Menopause
Actual Study Start Date :
May 19, 2017
Actual Primary Completion Date :
Feb 25, 2020
Actual Study Completion Date :
Feb 25, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hybrid Fractional Laser

Hybrid fractional 2940 nm and 1470 nm laser treatment

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in Vaginal Maturation Index (VMI) [12 months]

      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

    Secondary Outcome Measures

    1. Change from baseline in Histology [12 months]

      Change from baseline in epithelial thickness, collagen, elastin, vascularity, and fibroblast density.

    2. Change from baseline in Vaginal Health Index Score (VHIS) [12 months]

      A quantitative assessment of vaginal health that evaluates vaginal elasticity, fluid volume, pH, epithelial integrity, and moisture on a scale of 1 to 5.

    3. Change from baseline in Female Sexual Function Index (FSFI) [12 months]

      A multidimensional self-report instrument for assessment of female sexual function.

    4. Change from baseline in Day-to-Day Impact of Vaginal Aging Questionnaire (DIVA) [12 months]

      A multidimensional self-report measure of the impact of vaginal symptoms on functioning and well-being in postmenopausal women.

    5. Change from baseline in Clinical Photography [12 months]

      Change from baseline in the appearance of the treatment area.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Healthy biological female aged between 40 to 70 years

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

    3. No menses for at least 12 months

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

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

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

    7. Vaginal irritation in absence of infection

    8. Chronic burning sensation

    9. Chronic itching in the absence of infection

    10. Recurring urinary tract infections (UTIs)

    11. Vaginal dryness during sexual activity

    12. Pain during sexual activity (dyspareunia)

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

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

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

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

    17. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Women's Pelvic Health Institute Los Gatos California United States 95032
    2 Coyle Institute Pensacola Florida United States 32514
    3 Louisiana State University New Orleans Louisiana United States 70112
    4 Carolinas Healthcare System Charlotte North Carolina United States 28207
    5 Woodlands Gynecology & Aesthetics The Woodlands Texas United States 77384
    6 The Female Pelvic Medicine Institute of Virginia North Chesterfield Virginia United States 23235

    Sponsors and Collaborators

    • Sciton

    Investigators

    • Principal Investigator: Nathan Guerette, MD, The Female Pelvic Institute of Virginia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sciton
    ClinicalTrials.gov Identifier:
    NCT03178825
    Other Study ID Numbers:
    • DIVACIP002
    First Posted:
    Jun 7, 2017
    Last Update Posted:
    Aug 11, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Dyspareunia

    Study Results

    No Results Posted as of Aug 11, 2020