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Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause

Primary Purpose

Vaginal Atrophy, Sexual Dysfunction, Dyspareunia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hybrid Fractional Laser
Sponsored by
Sciton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Atrophy

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Women's Pelvic Health Institute
  • Coyle Institute
  • Louisiana State University
  • Carolinas Healthcare System
  • Woodlands Gynecology & Aesthetics
  • The Female Pelvic Medicine Institute of Virginia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hybrid Fractional Laser

Arm Description

Hybrid fractional 2940 nm and 1470 nm laser treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in Histology
Change from baseline in epithelial thickness, collagen, elastin, vascularity, and fibroblast density.
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.
Change from baseline in Female Sexual Function Index (FSFI)
A multidimensional self-report instrument for assessment of female sexual function.
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.
Change from baseline in Clinical Photography
Change from baseline in the appearance of the treatment area.

Full Information

First Posted
June 5, 2017
Last Updated
August 10, 2020
Sponsor
Sciton
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1. Study Identification

Unique Protocol Identification Number
NCT03178825
Brief Title
Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause
Official Title
Safety and Efficacy of Hybrid Fractional Laser Treatment for Symptoms of Genitourinary Syndrome of Menopause
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 19, 2017 (Actual)
Primary Completion Date
February 25, 2020 (Actual)
Study Completion Date
February 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sciton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Atrophy, Sexual Dysfunction, Dyspareunia, Vaginal Dryness, Chronic UTI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hybrid Fractional Laser
Arm Type
Experimental
Arm Description
Hybrid fractional 2940 nm and 1470 nm laser treatment
Intervention Type
Device
Intervention Name(s)
Hybrid Fractional Laser
Other Intervention Name(s)
diVa
Intervention Description
Consecutive and coincident fractional 2940 nm and 1470 nm lasers
Primary Outcome Measure Information:
Title
Change from baseline in Vaginal Maturation Index (VMI)
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change from baseline in Histology
Description
Change from baseline in epithelial thickness, collagen, elastin, vascularity, and fibroblast density.
Time Frame
12 months
Title
Change from baseline in Vaginal Health Index Score (VHIS)
Description
A quantitative assessment of vaginal health that evaluates vaginal elasticity, fluid volume, pH, epithelial integrity, and moisture on a scale of 1 to 5.
Time Frame
12 months
Title
Change from baseline in Female Sexual Function Index (FSFI)
Description
A multidimensional self-report instrument for assessment of female sexual function.
Time Frame
12 months
Title
Change from baseline in Day-to-Day Impact of Vaginal Aging Questionnaire (DIVA)
Description
A multidimensional self-report measure of the impact of vaginal symptoms on functioning and well-being in postmenopausal women.
Time Frame
12 months
Title
Change from baseline in Clinical Photography
Description
Change from baseline in the appearance of the treatment area.
Time Frame
12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postmenopausal Females
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy biological female aged between 40 to 70 years Is post-menopausal with a AND b OR c No menses for at least 12 months Follicle-stimulating hormone (FSH) level over 40mlU/mL Has had a bilateral oophorectomy at least 12 months ago with no hormone replacement Is experiencing at least two self-reported symptoms of GSM, such as Vaginal irritation in absence of infection Chronic burning sensation Chronic itching in the absence of infection Recurring urinary tract infections (UTIs) Vaginal dryness during sexual activity Pain during sexual activity (dyspareunia) 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: Undiagnosed abnormal genital bleeding Has history of pelvic surgery or other energy-based vaginal therapy within 6 months prior to enrollment Previous use of topical estrogen therapy within the last 3 months Has used vaginal creams, moisturizers, lubricants or homeopathic preparations or received anticoagulants, antiplatelet, thrombolytic, vitamin E or anti-inflammatory within 2 weeks of treatment History of heart failure Has equal to or greater than stage III prolapse, according to pelvic organ prolapse quantification system (POP-Q) Has an active sexually transmitted infection (STI) Has signs or symptoms of vaginitis/vulvitis Has signs or symptoms of acute urinary tract infection (UTI) Has participated in any clinical trial involving an investigational drug or procedure within the past 30 days The investigator feels that for any reason the subject is not eligible to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Guerette, MD
Organizational Affiliation
The Female Pelvic Institute of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Pelvic Health Institute
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Coyle Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
Louisiana State University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Carolinas Healthcare System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Woodlands Gynecology & Aesthetics
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
The Female Pelvic Medicine Institute of Virginia
City
North Chesterfield
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause

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