Sexual Function Disturbances, Systemic Sclerosis, Vulvovaginal Signs and Symptoms
Conditions
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.
Interventions
DEVICECO2 Vaginal Laser
CO2 Vaginal laser
Sponsors
IRCCS San Raffaele
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Systemic Sclerosis; - vulvovaginal symptoms
Exclusion criteria
* gynecological neoplasia; - pregnancy; - pelvic organ prolapse; - vaginal and urinary infection; - pudendal neuropathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-5 Likert Scale | Six months follow up | Scale of satisfaction for the treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed