Clinical trial NCT06142695: Ultrasonic Evaluation of Carbon Dioxide Laser Effects on Patients With Genitourinary Syndrome
Official title: Ultrasonic Evaluation of Carbon Dioxide Laser Effects on Patients With Genitourinary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genitourinary Syndrome of Menopause
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 31
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Menopausal patients that attended our clinic of menopausal disorders and performed Carbon Dioxide Laser therapy for genitourinary syndrome.

In order to enroll patients with Genitourinary Syndrome of Menopause, the investigator used the Vaginal Health Index (VHI), Vulvar Health Index (VuHI), and Stress Urinary Incontinence (SUI) scales.

* The VHI score assesses vaginal health, with a cutoff of \<15 on the index to diagnose patients with atrophy \[ranging from "complete atrophy" (0) to "optimal vaginal health" (25)\].
* The VuHI score assesses vulvar health, on a scale from normal (0) to severe (3). The overall score ranges from 0 to 24, and its cutoff for diagnosing atrophic vulva is \>8 on the index.
* Stress Urinary Incontinence (SUI) is characterized by sudden urine loss. Evaluated using the Stamey score, with ratings of no incontinence (0) to severe incontinence (3).

Brief summary: The aim of the study was to evaluate the efficacy of vaginal Carbon Dioxide Laser treatment in patients with Genitourinary Syndrome of Menopause on the improvement of Vulvovaginal Atrophy (VVA) and stress urinary incontinence (SUI) by objective parameters and in particular to assess the ultrasound measurement of specific vaginal parameters in order to evaluate a new objective tool of assessment.


Eligibility criteria: Inclusion Criteria:

* Age \<75 years, menopause (naturally, pharmacologically or surgically induced, at least 12 months)
* Negative Papanicolaou test (PAP) performed within 12 months before enrolment. and one of the following:
* Presence of vulvovaginal atrophy \[vaginal health index (VHI) \< 15\]
* Initial Urinary Incontinence based on patient history = 1 (according to the "Stamey incontinence score of Stress Urinary Incontinence" - min. 0 = no incontinence, max. 3 = severe incontinence)
* Standardized stress provocation test

Exclusion Criteria:

* Age \>45 years
* The presence of vaginal lesions (active or in the previous 30 days).
* genitourinary tract infection.
* abnormal uterine bleeding.
* use of hormone replacement therapy up to 6 months before enrolment.
* history of photosensitivity disorder or use of photosensitizing drugs.
* genitals prolapse (grade II - III according to the Pelvic Organ Prolapse Quantification)
* a serious or chronic condition that could interfere with study compliance.

Primary outcomes:
measure: Evaluating the effectiveness of Carbon Dioxide Laser in patients with genitourinary syndrome of menopause in terms of the improvement in a specific vaginal ultrasonographic parameters
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: FPG gemelli RCCS
state: Lazio
Study officials:
References: