NCT04868812

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

November 27, 2020

Last Update Submit

September 10, 2022

Conditions

Vaginal AtrophyBreast Cancer FemaleDyspareunia

Outcome Measures

Primary Outcomes (4)

  • Microscopic evaluation for vaginal epithelial thickness

    The vaginal epithelial thickness will be measured in micrometers. Then the difference in vaginal epithelial thickness between the biopsy obtained before and after the start of laser treatment will be calculated, considering a 20% increase as significant.

    4-5 weeks after the last treatment

  • Microscopic evaluation of number of papillae

    The number of papillae in bioptic samples will be analyzed with Hematoxylin- Eosin and Trichrome staining.

    4-5 weeks after the last treatment

  • Microscopic evaluation of glycogen amount

    The amount of glycogen present at the epithelial level and the ratio between the number of type I collagen fibers and type III will be evaluated with PAS reaction for glycogen.

    4-5 weeks after the last treatment

  • Microscopic evaluation of number and size of the vessels

    The number and size of the vessels present in the subepithelial layer will be evaluated using immunohistochemistry for CD34, a vessel marker.

    4-5 weeks after the last treatment

Secondary Outcomes (5)

  • Validated questionnaires VHI

    4-5 weeks after the last treatment

  • Validated questionnaires FSFI

    4-5 weeks after the last treatment

  • Validated questionnaires UDI-6

    4-5 weeks after the last treatment

  • Validated questionnaires ICIQ-UI

    4-5 weeks after the last treatment

  • Validated questionnaires LIKERT

    4-5 weeks after the last treatment

Study Arms (1)

Patient

EXPERIMENTAL

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.

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

Interventions

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

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

Patient

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele Hospital

Milan, 20132, Italy

Location

Related Publications (5)

  • 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.

    PMID: 30601037BACKGROUND

  • 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.

    PMID: 23985562BACKGROUND

  • 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.

    PMID: 25410301BACKGROUND

  • 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.

    PMID: 24605832BACKGROUND

  • Casiraghi A, Calligaro A, Zerbinati N, Doglioli M, Ruffolo AF, Candiani M, Salvatore S. Long-term clinical and histological safety and efficacy of the CO2 laser for treatment of genitourinary syndrome of menopause: an original study. Climacteric. 2023 Dec;26(6):605-612. doi: 10.1080/13697137.2023.2246886. Epub 2023 Aug 31.

    PMID: 37650754DERIVED

MeSH Terms

Conditions

Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Stefano Salvatore, MD

    IRCCS San Raffaele Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 27, 2020

First Posted

May 3, 2021

Study Start

December 3, 2019

Primary Completion

June 1, 2020

Study Completion

December 1, 2021

Last Updated

September 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)