Status:
COMPLETED
Ultrasonic Evaluation of Carbon Dioxide Laser Effects on Patients With Genitourinary Syndrome
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Genitourinary Syndrome of Menopause
Eligibility:
FEMALE
45-75 years
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 st...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 9 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT06142695
Start Date
January 11 2021
End Date
January 9 2022
Last Update
November 21 2023
Active Locations (1)
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1
FPG gemelli RCCS
Rome, Lazio, Italy, 00168