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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy | Device | SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy; MonaLisa Touch CO2 fractionated laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Validated questionnaires VHI | Vaginal Health Index (VHI) for evaluation of vaginal atrophy severity that is composed by the sum of 6 fields (min score 1 max score 5). The least score (6) is the worst; the maximum score (30) is the best. | 4-5 weeks after the last treatment |
| Validated questionnaires FSFI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Salvatore, MD | IRCCS San Raffaele Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele Hospital | Milan | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30601037 | Background | 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. | |
| 23985562 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 20, 2019 | Apr 22, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D004414 | Dyspareunia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Female Sexual Function Index (FSFI) questionnaire which will assess female sexual function that is composed of 19 fields. The minimum score is 2 in the worst situation; maximum score is 36 in the best situation |
| 4-5 weeks after the last treatment |
| Validated questionnaires UDI-6 | Urinary Distress Inventory-6 (UDI-6) is a 6 fields questionnaires on voiding function. The minimum score is 0 in absence of symptoms; 18 is the maximum score in the worst situation. | 4-5 weeks after the last treatment |
| Validated questionnaires ICIQ-UI | International Consultation on Incontinence Questionnaire - Urinary Incontinence (ICIQ-UI) which will evaluate the extent of urinary symptoms. It is divided into two parts: questions 1, 2 and 3 are added together and the maximum score is 22, in worst condition; a score of zero is obtained in asymptomatic patients. The last is a describing question. | 4-5 weeks after the last treatment |
| Validated questionnaires LIKERT | 5-point Likert scale is made to assess the impact of GSM symptoms on quality of life (QoL). It is a descriptive question. | 4-5 weeks after the last treatment |
| 25410301 | Background | 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. |
| 24605832 | Background | 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. |
| 37650754 | Derived | 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. |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |