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

Genitourinary Syndrome of Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06142695
• Other study ID #: 4689
• Status: Completed
• Start date: January 11, 2021
• Est. completion date: January 9, 2022

Study information

• Verified date: November 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 9, 2022
• Est. primary completion date: December 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Genitourinary Syndrome of Menopause
• Syndrome

Locations

Country	Name	City	State
Italy	FPG gemelli RCCS	Roma	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	4 months