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

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

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-03

Study Completion Date

2021-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vaginal Atrophy Breast Cancer Female Dyspareunia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patient

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. A clinical evaluation will be recorded for each patient using validated questionnaires at baseline and one month after the last procedure.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy; MonaLisa Touch CO2 fractionated laser

Interventions

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

SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy; MonaLisa Touch CO2 fractionated laser

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No