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

IRCCS San Raffaele16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Sclerosis Vulvovaginal Signs and Symptoms Sexual Function Disturbances

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of Systemic Sclerosis; - vulvovaginal symptoms Exclusion Criteria: * gynecological neoplasia; - pregnancy; - pelvic organ prolapse; - vaginal and urinary infection; - pudendal neuropathy

Locations (1)

IRCCS San Raffaele

Milan, Italy

Outcomes

Primary Outcomes

1-5 Likert Scale

Scale of satisfaction for the treatment

Time frame: Six months follow up

Secondary Outcomes

0-10 Visual Analogue Scale

Scale of vulvovaginal symptoms severity

Time frame: Six months follow up

Female Sexual Function Index

Questionnaire assessing sexual function

Time frame: Six months follow up

Data from ClinicalTrials.gov

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