Clinical trial · Interventional
Histological Modifications of Postmenopausal Vaginal Mucosa After Repeated Carbon Dioxide (CO2) Laser Treatment
Histological Modifications of Postmenopausal Vaginal Mucosa After Repeated CO2 Laser
NCT04868812CI-TRIAL-00060812REPLAMODcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Dyspareunia | — | UNRESOLVED | — |
| Vaginal Atrophy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patient
- description
- 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.
- interventionNames
- Device: SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy
Primary outcomes (4)
- measure
- Microscopic evaluation for vaginal epithelial thickness
- timeFrame
- 4-5 weeks after the last treatment
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDCagnacci 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 30601037
- BACKGROUNDManagement 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 23985562
- BACKGROUNDZerbinati 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 25410301
- BACKGROUNDSalvatore 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 24605832
- DERIVEDCasiraghi 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 37650754