Effects of Fractional CO2 Laser Treatment on Vaginal Symptoms and Sexual Dysfunction in Women With Systemic Sclerosis

Phase 2

Completed

• Conditions: Vulvovaginal Signs and Symptoms; Systemic Sclerosis; Sexual Function Disturbances
• Interventions: Device: CO2 Vaginal Laser

• Registration Number: NCT06231433
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

Women affected by Systemic Sclerosis and Vulvovaginal Atrophy will be submitted to a cycle composed of five vaginal CO2 laser treatment (SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy - Hi Scan V2LR con sonda vaginale a 360 °, dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μm smart stack 1-3, emission mode deka pulse) every 30-40 days.

At 1-month follow up from the last vaginal laser treatment (6 months from baseline) vagina and sexual health will be assessed by a 1-5 Likert scale, a 0-10 Visual Analogue Scale for vulvovaginal symptoms and the Female Sexual Function Index.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-01
• Primary Completion: 2022-05-03
• Study Completion: 2022-05-03
• Status Verified: 2024-01
• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Last Update Submitted: 2024-01-22
• Study First Posted: 2024-01-30
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

• Diagnosis of Systemic Sclerosis; - vulvovaginal symptoms

Exclusion Criteria

• gynecological neoplasia; - pregnancy; - pelvic organ prolapse; - vaginal and urinary infection; - pudendal neuropathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Women affected by Systemic Sclerosis and vulvovaginal atrophy	CO2 Vaginal Laser	CO2 vaginal laser

Primary Outcome Measures

Name	Time	Method
1-5 Likert Scale	Six months follow up	Scale of satisfaction for the treatment

Secondary Outcome Measures

Name	Time	Method
0-10 Visual Analogue Scale	Six months follow up	Scale of vulvovaginal symptoms severity
Female Sexual Function Index	Six months follow up	Questionnaire assessing sexual function

Trial Locations

Locations (1)

IRCCS San Raffaele; 🇮🇹 Milan, Italy