Clinical trial NCT04297319: The Use of Laser in the Treatment of Atrophic Vulvovaginitis
Official title: The Use of Laser in the Treatment of Atrophic Vulvovaginitis and Its Consequent Improvement in Sexual Satisfaction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lasers
Atrophy of Vagina
Atrophy Vulva
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 20
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, randomized, control clinical trial
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy and security of laser for atrophy treatment. Half of participants will receive the laser treatment and the other half placebo.

Detailed description: Thermal laser treatments are proposed as the newest treatments for atrophy. Through the thermal effect it would stimulates de mucosa, enhances the collagen component and the vascularization. Collagen remodeling and new collagen synthesis has been suggested as a mechanism of laser induced skin resurfacing and remodeling of vaginal connective tissue.

Eligibility criteria: Inclusion Criteria:

* Menopause women with vulvovaginal symptoms of atrophy
* No previous estrogen treatment for the last 30 days
* Active sexual life (vaginal penetration)
* Accept to participate
* Pap atrophy or hypotrophy in the last year

Exclusion Criteria:

* Vulvovaginal diseases
* Abnormal uterine bleeding
* Antidepressants drugs
* Uncontrolled diabetes
* Cervical intraepithelial lesions or cancer
* Photosensitized or under treatment with photosensibilized drugs
* Collagen diseases
* Vulvovaginal infections in the last 15 days
* Immunosuppressed patients or under immunosuppressed treatments

Primary outcomes:
measure: Change from Baseline in Female Sexual Function Index questionnaire
timeFrame: baseline, and week 4 after treatment
measure: Change from Baseline in Female Sexual Function Index questionnaire
timeFrame: baseline,and week 12 after treatment
measure: Change from Baseline in Female Sexual Function Index questionnaire
timeFrame: baseline, and week 36 after treatment
measure: Vaginal Cytology Improvement
timeFrame: baseline, and week 4 after treatment
measure: Vaginal Cytology Improvement
timeFrame: baseline, and week 12 after treatment
measure: Vaginal Cytology Improvement
timeFrame: baseline, and week 36 after treatment
measure: Change in vaginal acidity measure
timeFrame: baseline, and week 4 after treatment
measure: Change in vaginal acidity measure
timeFrame: baseline, and week 12 after treatment
measure: Change in vaginal pH measure
timeFrame: baseline,and week 36 after treatment
Secondary outcomes:
measure: Number of patient with Local Estrogen therapy requirement post intervention
timeFrame: baseline,and week 48
Other outcomes:
measure: Number of participant with Adverse events reported in each visit
timeFrame: Baseline,and week 48
Locations:
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires, Argentina
name: claudia E Marchitelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Knight C, Logan V, Fenlon D. A systematic review of laser therapy for vulvovaginal atrophy/genitourinary syndrome of menopause in breast cancer survivors. Ecancermedicalscience. 2019 Dec 12;13:988. doi: 10.3332/ecancer.2019.988. eCollection 2019.
citation: Adabi K, Golshahi F, Niroomansh S, Razzaghi Z, Ghaemi M. Effect of the Fractional CO2 Laser on the Quality of Life, General Health, and Genitourinary Symptoms in Postmenopausal Women With Vaginal Atrophy: A Prospective Cohort. J Lasers Med Sci. 2020 Winter;11(1):65-69. doi: 10.15171/jlms.2020.11. Epub 2020 Jan 18.