The Use of Laser in the Treatment of Atrophic Vulvovaginitis

The Use of Laser in the Treatment of Atrophic Vulvovaginitis and Its Consequent Improvement in Sexual Satisfaction

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.

Study Overview

• Status: Terminated
• Conditions: Lasers; Atrophy of Vagina; Atrophy Vulva
• Intervention / Treatment: Procedure: Laser diiodo; Procedure: Laser 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, 1199
    • Hospital Italiano de Buenos Aires

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 - Laser intervention; Laser diiodo treatment, 3 procedures of 5-10 minutes at intervals of 4 weeks	Procedure: Laser diiodo; 3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks It is an outpatient procedure, not anesthesia required.
Placebo Comparator: 2 - Laser placebo; Only the laser speculum is placed in the vagina but the laser is not activated. 3 procedures of 5-10 minutes at intervals of 4 weeks	Procedure: Laser Placebo; 3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks. It is an outpatient procedure, not anesthesia required.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Female Sexual Function Index questionnaire	Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome	baseline, and week 4 after treatment
Change from Baseline in Female Sexual Function Index questionnaire	Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome	baseline,and week 12 after treatment
Change from Baseline in Female Sexual Function Index questionnaire	Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome	baseline, and week 36 after treatment
Vaginal Cytology Improvement	Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy	baseline, and week 4 after treatment
Vaginal Cytology Improvement	Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy	baseline, and week 12 after treatment
Vaginal Cytology Improvement	Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy	baseline, and week 36 after treatment
Change in vaginal acidity measure	the normal vaginal acidity is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)	baseline, and week 4 after treatment
Change in vaginal acidity measure	the normal vaginal acidity is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)	baseline, and week 12 after treatment
Change in vaginal pH measure	the normal vaginal ph is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)	baseline,and week 36 after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patient with Local Estrogen therapy requirement post intervention	Number of patients that Need estrogen replacement for atrophy vulvovaginal symptoms, despite the intervention.This will be evaluate with a Yes/No question.	baseline,and week 48

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participant with Adverse events reported in each visit	It will be evaluate the number of patients that reported adverse events such as dyspareunia, irritation, edema, vaginal dryness, genital bleeding, vaginal discharge, pain, lesions	Baseline,and week 48

Collaborators and Investigators

• Sponsor: Hospital Italiano de Buenos Aires
• Investigators: Principal Investigator: claudia E Marchitelli, MD, Hospital Italiano de Buenos Aires, Argentina

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2019
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Atrophy; Vulvovaginitis
• Other Study ID Numbers: 5076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No