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

Last updated: January 22, 2024
Sponsor: IRCCS San Raffaele
Overall Status: Completed

Phase

2/3

Condition

Connective Tissue Diseases

Scleroderma

Scar Tissue

Treatment

CO2 Vaginal Laser

Clinical Study ID

NCT06231433
SCLERODERMCO2
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Systemic Sclerosis; - vulvovaginal symptoms

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: CO2 Vaginal Laser
Phase: 2/3
Study Start date:
May 01, 2020
Estimated Completion Date:
May 03, 2022

Connect with a study center

  • IRCCS San Raffaele

    Milan, 20132
    Italy

    Site Not Available

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