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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-11

Study Completion Date

2022-01-09

Brief Summary

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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

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Conditions

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Genitourinary Syndrome of Menopause

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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VILLA PAOLA

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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FPG gemelli RCCS

Rome, Lazio, Italy

Site Status

Countries

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Italy

Other Identifiers

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4689

Identifier Type: -

Identifier Source: org_study_id