Histological Modifications of Postmenopausal Vaginal Mucosa After Repeated Carbon Dioxide (CO2) Laser Treatment (REPLAMOD)

San Donato Group (GSD)

Status

Completed

Conditions

Breast Cancer Female

Dyspareunia

Vaginal Atrophy

Treatments

Device: SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy

Study type

Interventional

Funder types

Other

Identifiers

NCT04868812

REPLAMOD

Details and patient eligibility

About

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.

Full 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 term MonaLisa Touch will significantly improve GSM histologically and clinically from baseline.

The primary outcome objective of the study is to evaluate the histological modifications of the vaginal mucosa after repeated CO2 Monalisa Touch laser treatment. The investigator shall evaluate the role of this treatment by calculating the difference in vaginal epithelial thickness between the biopsy obtained before the start of laser treatment and the biopsy obtained after treatment. In addition, the study will analyze the safety of repeated laser treatments verifying the absence of fibrosis formation in the vaginal mucosa. Secondary objectives of the study will include an evaluation of the clinical effects associated with repeated Monalisa Touch CO2 laser treatments using validated questionnaires.

All participants will be screened to ensure inclusion/exclusion criteria are met. A biopsy will be taken from each patient one month before the first laser treatment and one month after the last laser treatment. The MonaLisa treatment will be performed monthly for 3 months. MonaLisa treatment with fractional microablative laser system. For subjects with concomitant vulvar symptoms, vulvar treatment will be done. Biopsy samples will be analyzed with Hematoxylin- Eosin and Trichrome staining, Periodic acid-Schiff (PAS) reaction for glycogen and immunohistochemistry for CD34, a vessel marker. All clinical questionnaires will be assessed at baseline and at one month after the last session.

Enrollment

15 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.