Clinical trial NCT03178825: 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
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Atrophy
Sexual Dysfunction
Dyspareunia
Vaginal Dryness
Chronic UTI
Lead sponsor: Sciton
Sponsor class: INDUSTRY
First posted: 2017-06-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in Vaginal Maturation Index (VMI)
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline in Histology
timeFrame: 12 months
measure: Change from baseline in Vaginal Health Index Score (VHIS)
timeFrame: 12 months
measure: Change from baseline in Female Sexual Function Index (FSFI)
timeFrame: 12 months
measure: Change from baseline in Day-to-Day Impact of Vaginal Aging Questionnaire (DIVA)
timeFrame: 12 months
measure: Change from baseline in Clinical Photography
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Gatos
country: United States
facility: Women's Pelvic Health Institute
state: California
city: Pensacola
country: United States
facility: Coyle Institute
state: Florida
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Charlotte
country: United States
facility: Carolinas Healthcare System
state: North Carolina
city: The Woodlands
country: United States
facility: Woodlands Gynecology & Aesthetics
state: Texas
city: North Chesterfield
country: United States
facility: The Female Pelvic Medicine Institute of Virginia
state: Virginia
Study officials:
affiliation: The Female Pelvic Institute of Virginia
name: Nathan Guerette, MD
role: PRINCIPAL_INVESTIGATOR
References: