The Use of Laser in the Treatment of Atrophic Vulvovaginitis

Not Applicable

Terminated

• Conditions: Lasers; Atrophy of Vagina; Atrophy Vulva
• Interventions: Procedure: Laser diiodo; Procedure: Laser Placebo

• Registration Number: NCT04297319
• Lead Sponsor: Hospital Italiano de Buenos Aires

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.

Study Timeline

• Study Start: 2019-09-20
• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-05
• Primary Completion: 2021-05-01
• Study Completion: 2021-12-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 - Laser intervention	Laser diiodo	Laser diiodo treatment, 3 procedures of 5-10 minutes at intervals of 4 weeks
2 - Laser placebo	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

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Female Sexual Function Index questionnaire	baseline, and week 36 after treatment	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
Vaginal Cytology Improvement	baseline, and week 36 after treatment	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
Change in vaginal acidity measure	baseline, and week 12 after treatment	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)
Change in vaginal pH measure	baseline,and week 36 after treatment	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Caba, Argentina