Ultrasonic Evaluation of Carbon Dioxide Laser Effects on Patients With Genitourinary Syndrome

Completed

• Conditions: Genitourinary Syndrome of Menopause

• Registration Number: NCT06142695
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-11
• Primary Completion: 2021-12-12
• Study Completion: 2022-01-09
• Study First Submitted: 2023-07-18
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-20
• Last Update Submitted: 2023-11-20
• Study First Posted: 2023-11-21
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	4 months	To evaluate the primary outcome, we examined the following vaginal ultrasonographic parameters (by transvaginal probe), both before and after 3 vaginal Carbon Dioxide Laser applications: * Thickness of the anterior vaginal walls (VWT) at the level of the introitus of the inferior vaginal third (expressed in millimeters); * Thickness of the posterior VWT at the level of the introitus of the inferior vaginal third (expressed in millimeters).; Positive outcomes are evidenced if thickness (expressed in millimeters) is increased after treatment in both anterior and posterior vaginal walls.

Trial Locations

Locations (1)

FPG gemelli RCCS; 🇮🇹 Roma, Lazio, Italy