Effects of Fractional CO2 Laser Treatment on Vaginal Symptoms and Sexual Dysfunction in Women With Systemic Sclerosis
- Conditions
- Vulvovaginal Signs and SymptomsSystemic SclerosisSexual Function Disturbances
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 16
- Diagnosis of Systemic Sclerosis; - vulvovaginal symptoms
- gynecological neoplasia; - pregnancy; - pelvic organ prolapse; - vaginal and urinary infection; - pudendal neuropathy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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
IRCCS San Raffaele🇮🇹Milan, Italy