Vaginal AtrophyREPLAMODNCT04868812
Histological Modifications of Postmenopausal Vaginal Mucosa After Repeated Carbon Dioxide (CO2) Laser Treatment
A study testing SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy in people with Vaginal Atrophy and Breast Cancer Female, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Vaginal Atrophy, Breast Cancer Female, Dyspareunia
- What is being tested?
- SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 3 Dec 2019to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Histological Modifications of Postmenopausal Vaginal Mucosa After Repeated CO2 Laser
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.
Read the 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.
- Conditions
- Vaginal Atrophy, Breast Cancer Female, Dyspareunia
- Being tested
- SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4-5 weeks after the last treatment
Secondary outcomes (5)
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.
Measured: 4-5 weeks after the last treatment
Validated questionnaires FSFI
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4-5 weeks after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start3 Dec 2019
- Primary completion1 Jun 2020
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vaginal AtrophyStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Salvatore, IRCCS San Raffaele
- Investigators
- Stefano Salvatore, MD, Principal investigator, IRCCS San Raffaele Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868812
- Sponsor's protocol ID
- REPLAMOD
- Acronym
- REPLAMOD
- Status last verified
- Sep 2022
- First submitted
- 27 Nov 2020
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30601037Management 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.
PubMed 23985562Zerbinati 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.
PubMed 25410301Salvatore 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.
PubMed 24605832Casiraghi 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.
PubMed 37650754
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Modifications of Postmenopausal Vaginal Mucosa After Repeated CO2 Laser
- ClinicalTrials.gov ID
- NCT04868812
- Acronym / sponsor ID
- REPLAMOD / REPLAMOD
- Conditions
- Vaginal Atrophy, Breast Cancer Female, Dyspareunia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Device: SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, ItalyAll 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, ItalySmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy; MonaLisa Touch CO2 fractionated laser | Device | Patient |
Primary outcome
Microscopic evaluation for vaginal epithelial thickness
Time frame: 4-5 weeks after the last treatment
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.
Microscopic evaluation of number of papillae
Time frame: 4-5 weeks after the last treatment
The number of papillae in bioptic samples will be analyzed with Hematoxylin- Eosin and Trichrome staining.
Microscopic evaluation of glycogen amount
Time frame: 4-5 weeks after the last treatment
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.
Microscopic evaluation of number and size of the vessels
Time frame: 4-5 weeks after the last treatment
The number and size of the vessels present in the subepithelial layer will be evaluated using immunohistochemistry for CD34, a vessel marker.
5 secondary outcomes
Validated questionnaires VHI
Time frame: 4-5 weeks after the last treatment
Validated questionnaires FSFI
Time frame: 4-5 weeks after the last treatment
Validated questionnaires UDI-6
Time frame: 4-5 weeks after the last treatment
Validated questionnaires ICIQ-UI
Time frame: 4-5 weeks after the last treatment
Validated questionnaires LIKERT
Time frame: 4-5 weeks after the last treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Background: PubMed 30601037Cagnacci 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.
- Background: PubMed 23985562Management 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.
- Background: PubMed 25410301Zerbinati 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.
- Background: PubMed 24605832Salvatore 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.
- Derived from this study: PubMed 37650754Casiraghi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Salvatore, MD principal investigator
IRCCS San Raffaele Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy in people with Vaginal Atrophy and Breast Cancer Female, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microscopic evaluation for vaginal epithelial thickness (time frame: 4-5 weeks after the last treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04868812, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.