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OpenTrials
Completed

NCT Number: NCT06142695

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

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.

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Key information

Conditions

Genitourinary Syndrome of Menopause

Age range

45 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

FPG gemelli RCCS

Rome, Lazio, 00168, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Nov 21, 2023
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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