Effects of Fractional CO2 Laser Treatment on Vaginal Symptoms and Sexual Dysfunction in Women With Systemic Sclerosis (SCLERDERMCO2)

San Donato Group (GSD)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Vulvovaginal Signs and Symptoms; Systemic Sclerosis; Sexual Function Disturbances

Treatments: Device: CO2 Vaginal Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT06231433

SCLERODERMCO2

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Systemic Sclerosis; - vulvovaginal symptoms

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Women affected by Systemic Sclerosis and vulvovaginal atrophy

Experimental group

Description:

CO2 vaginal laser

Treatment:

Device: CO2 Vaginal Laser