Clinical trial NCT04868812: Histological Modifications of Postmenopausal Vaginal Mucosa After Repeated Carbon Dioxide (CO2) Laser Treatment
Official title: Histological Modifications of Postmenopausal Vaginal Mucosa After Repeated CO2 Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Atrophy
Breast Cancer Female
Dyspareunia
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Microscopic evaluation for vaginal epithelial thickness
timeFrame: 4-5 weeks after the last treatment
measure: Microscopic evaluation of number of papillae
timeFrame: 4-5 weeks after the last treatment
measure: Microscopic evaluation of glycogen amount
timeFrame: 4-5 weeks after the last treatment
measure: Microscopic evaluation of number and size of the vessels
timeFrame: 4-5 weeks after the last treatment
Secondary outcomes:
measure: Validated questionnaires VHI
timeFrame: 4-5 weeks after the last treatment
measure: Validated questionnaires FSFI
timeFrame: 4-5 weeks after the last treatment
measure: Validated questionnaires UDI-6
timeFrame: 4-5 weeks after the last treatment
measure: Validated questionnaires ICIQ-UI
timeFrame: 4-5 weeks after the last treatment
measure: Validated questionnaires LIKERT
timeFrame: 4-5 weeks after the last treatment
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Hospital
Study officials:
affiliation: IRCCS San Raffaele Hospital
name: Stefano Salvatore, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cagnacci A, Xholli A, Sclauzero M, Venier M, Palma F, Gambacciani M; writing group of the ANGEL study. Vaginal atrophy across the menopausal age: results from the ANGEL study. Climacteric. 2019 Feb;22(1):85-89. doi: 10.1080/13697137.2018.1529748. Epub 2019 Jan 2.
citation: Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2.
citation: Zerbinati N, Serati M, Origoni M, Candiani M, Iannitti T, Salvatore S, Marotta F, Calligaro A. Microscopic and ultrastructural modifications of postmenopausal atrophic vaginal mucosa after fractional carbon dioxide laser treatment. Lasers Med Sci. 2015 Jan;30(1):429-36. doi: 10.1007/s10103-014-1677-2. Epub 2014 Nov 20.
citation: Salvatore S, Nappi RE, Zerbinati N, Calligaro A, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study. Climacteric. 2014 Aug;17(4):363-9. doi: 10.3109/13697137.2014.899347. Epub 2014 Jun 5.