Status:
COMPLETED
Histological Modifications of Postmenopausal Vaginal Mucosa After Repeated Carbon Dioxide (CO2) Laser Treatment
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Vaginal Atrophy
Breast Cancer Female
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
To assess the long-term histological and clinical efficacy of MonaLisa Touch procedure for the management of the Genitourinary Syndrome of Menopause (GSM) in postmenopausal female patients.
Detailed Description
The investigator propose a prospective case series of 15 postmenopausal women with bothersome symptoms of GSM treated with MonaLisa Touch CO2 laser. The investigator hypothesize that even in the long ...
Eligibility Criteria
Inclusion
- Italian speaking and able to give informed consent.
- Menopausal females with absence of menstruation for at least 12 months.
- Presence of GSM symptoms.
- Completion of at least two cycles of three laser treatments sessions in previous years.
- Prolapse stage \< II, according to the pelvic organ prolapse quantification (POP-Q) system.
- No pelvic surgery within 6 months prior to treatment.
- Understanding and acceptance to the obligation to return to all scheduled visits and follow-ups.
Exclusion
- Inability of give informed consent
- History of vulvovaginal condyloma, vaginal intraepithelial neoplasia (VAIN), vaginal carcinoma, lichen sclerosis, lichen planus.
- History of cancers of the lower genital tract (cervix, uterus, vagina).
- History of pelvic radiotherapy.
- Personal history of genital fistula, a thin recto-vaginal septum as determined by the investigator or personal history of a fourth degree laceration during screening physical exam.
- Any other medical condition that the investigators feel would compromise the study.
- Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. bacterial vaginosis, herpes genitalis, candida).
- Stage III or IV pelvic organ prolapse.
- History of any female sexual disorder.
Key Trial Info
Start Date :
December 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04868812
Start Date
December 3 2019
End Date
December 1 2021
Last Update
September 13 2022
Active Locations (1)
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1
IRCCS San Raffaele Hospital
Milan, Italy, 20132