To Assess Signs and Symptoms in Women Affected by GSM After One Cycle of Pixel CO2-Alma Fractionated Laser
Primary Purpose
Genitourinary Syndrome of Menopause (GSM), Vaginal Dryness, Burning
Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Fractionated Laser (Pixel CO2-Alma)
Fractionated Laser (Pixel CO.2-Alma)
Sponsored by
About this trial
This is an interventional treatment trial for Genitourinary Syndrome of Menopause (GSM) focused on measuring Genitourinary syndrome of menopause (GSM), Fractionated Laser, Vaginal dryness., dyspareunia
Eligibility Criteria
Inclusion Criteria:
- menopausal women aged between 40 and 70 years old (defined as Absence of menstruation for 12 consecutive months).
- women affected by Genitourinary syndrome of menopause (GSM) with Vaginal dryness, burning/pain, dyspareunia, dysuria.
- women not treated with Replacement therapy with estrogen and progestogen (HT) or estrogen alone (ET) or selective estrogen receptor modulators (SERMS) in the last 3 months
Exclusion Criteria:
- hypersensitivity to laser
- clinically significant findings on physical examination
- any chronic medical condition or psychologic disorder that per opinion of the Principal Investigator would make the patient ineligible for the study
- vulvo-vestibular lesion not related with GSM
- active vaginal or vulvar infections (e.g., herpes, candida, STIs)
- prolapse beyond the hymen
- subject has a history of scarring alteration (ie, keloid formation)
- unknown past or active history of vaginal bleeding disorders
- any condition or behavior indicating to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits
Sites / Locations
- Ospedale dei Bambini V Buzzi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fractionated Laser
Fractionated.Laser
Arm Description
Outcomes
Primary Outcome Measures
Vaginal dryness by Visual Analogue Scale
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Burning/pain by Visual Analogue Scale
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Dyspareunia by Visual Analogue Scale
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Pain/sensitivity to touch at Swab test by Visual Analogue Scale.
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Sexual Function by Female Sexual Function Index
Sexual function will be evaluated at baseline and after 84 and 120 days by the Italian validated translation of the Female Sexual Function Index (FSFI), a self-report instrument consisting of 19 items that assess sexual function over the past 4 weeks in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. Mean value in each group separately and in the two groups in comparison will be analyzed.
Vulval Pain by Vulval Pain Functional Questionnaire
The Vulval Pain Functional Questionnaire (VQ) will be used to quantify the extent that pelvic pain is affecting the patients. A numerical value is assigned to each response. The higher the score the greater the functional limitation. A diminishing score represents improvement.
Incidence of Treatment-Emergent Adverse Events/ Adverse Device Events/ Serious Adverse Events/ Serious Adverse Device Events [Safety and Tolerability]
The incidence will be calculated by searching for Adverse Event (AE), Adverse Device Event ADE, Serious Adverse Event (SAE), Serious Adverse Device Event (SADE) at each visit
Secondary Outcome Measures
Vestibular Trophism by Vaginal Health Index
The changing from baseline to day 84 (visit 5) and 120 (final visit) for Vaginal Health Index (VHI) mean value in each group separately and the changing in Arm A in comparison with that occurred in Arm B. The VHI score evaluates 5 parameters (vaginal elasticity, vaginal secretions, vaginal pH, epithelial mucous membrane, vaginal hydration) and to obtain a final score defining the degree of atrophy in the genitourinary tract by assigning a single score to each parameter. The minim score is 5 and the maxim is 25.
Vestibular Trophism by Vestibular Health Score
Vestibular Health Score (VHS) will be used by the Investigator evaluating 5 parameters (Petechiae, Pallor, Fragility, dryness, Erythema) and to obtain a final score defining the degree of atrophy. Each item is scored on a Likert scale between 0 =absent and 3 =severe. Total scores range from 0 to 15.
Full Information
NCT ID
NCT05156502
First Posted
October 27, 2021
Last Updated
December 12, 2021
Sponsor
Dr. Filippo Murina
Collaborators
Opera CRO, a TIGERMED Group Company
1. Study Identification
Unique Protocol Identification Number
NCT05156502
Brief Title
To Assess Signs and Symptoms in Women Affected by GSM After One Cycle of Pixel CO2-Alma Fractionated Laser
Official Title
An Open-Label, Interventional, Controlled Study To Assess The Performance And Tolerance Of Pixel CO2-Alma Fractionated Laser in Women Affected by GenitoUrinary Syndrome of Menopause (GSM)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 30, 2022 (Anticipated)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Filippo Murina
Collaborators
Opera CRO, a TIGERMED Group Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Genitourinary syndrome of menopause (GSM) occurs in approximately 50% of menopausal women but is both underrecognized and undertreated despite numerous treatment options. Vaginal dryness, irritation, dyspareunia, urinary frequency, and urinary urgency are some of the more common symptoms that can have a negative effect on women's lives and relationships. In particular, dyspareunia is localized in the vestibule with specific trophic changes more evident than those localized in vagina. The CO2 fractionated laser, has also been found to be useful in several studies for the treatment of vaginal atrophy.
In this open comparative study, 70 female menopausal subjects aged between 40 and 70 years old at inclusion, having symptoms of GSM (Vaginal dryness, burning/pain, dyspareunia,dysuria), have given her informed consent and meet all the eligibility criteria, will be enrolled. The two groups of comparison will be 35 subjects treated into vagina and vestibule, versus 35 subjects treated into vagina, only. Subjects will come to a total of 6 visits over a period of 3 months.
The primary objective of the study is to evaluate the performance and safety of Pixel CO2-Alma Fractionated Laser comparing its administration into vagina and vestibule versus into vagina, only. The evaluated outcomes are vaginal dryness, burning/pain, dyspareunia, sensitivity to touch at Swab test, Female Sexual Function Index (FSFI) and Vulval Pain Functional Questionnaire (VQ) at day 84 and 120 and the safety during all the study. The secondary objectives are the evaluation of vaginal and vestibular trophism, measured by Vaginal Health Index (VHI) and Vestibular Health Score (VHS) at the FU visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genitourinary Syndrome of Menopause (GSM), Vaginal Dryness, Burning, Pain, Dyspareunia, Dysuria
Keywords
Genitourinary syndrome of menopause (GSM), Fractionated Laser, Vaginal dryness., dyspareunia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fractionated Laser
Arm Type
Experimental
Arm Title
Fractionated.Laser
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Fractionated Laser (Pixel CO2-Alma)
Intervention Description
The Laser will be administered at baseline (visit 2, day 0), at visit 3 (day 28) and at visit 4 (day 56) into vagina and vestibule, following the IFU of the device.
Intervention Type
Device
Intervention Name(s)
Fractionated Laser (Pixel CO.2-Alma)
Intervention Description
Device: Fractionated Laser (Pixel CO2-Alma) The Laser will be administered at baseline (visit 2, day 0), at visit 3 (day 28) and at visit 4 (day 56) into vagina only, following the IFU of the device.
Primary Outcome Measure Information:
Title
Vaginal dryness by Visual Analogue Scale
Description
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Time Frame
120 days
Title
Burning/pain by Visual Analogue Scale
Description
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Time Frame
120 days
Title
Dyspareunia by Visual Analogue Scale
Description
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Time Frame
120 days
Title
Pain/sensitivity to touch at Swab test by Visual Analogue Scale.
Description
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Time Frame
120 days
Title
Sexual Function by Female Sexual Function Index
Description
Sexual function will be evaluated at baseline and after 84 and 120 days by the Italian validated translation of the Female Sexual Function Index (FSFI), a self-report instrument consisting of 19 items that assess sexual function over the past 4 weeks in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. Mean value in each group separately and in the two groups in comparison will be analyzed.
Time Frame
120 days
Title
Vulval Pain by Vulval Pain Functional Questionnaire
Description
The Vulval Pain Functional Questionnaire (VQ) will be used to quantify the extent that pelvic pain is affecting the patients. A numerical value is assigned to each response. The higher the score the greater the functional limitation. A diminishing score represents improvement.
Time Frame
120 days
Title
Incidence of Treatment-Emergent Adverse Events/ Adverse Device Events/ Serious Adverse Events/ Serious Adverse Device Events [Safety and Tolerability]
Description
The incidence will be calculated by searching for Adverse Event (AE), Adverse Device Event ADE, Serious Adverse Event (SAE), Serious Adverse Device Event (SADE) at each visit
Time Frame
up to 120 days
Secondary Outcome Measure Information:
Title
Vestibular Trophism by Vaginal Health Index
Description
The changing from baseline to day 84 (visit 5) and 120 (final visit) for Vaginal Health Index (VHI) mean value in each group separately and the changing in Arm A in comparison with that occurred in Arm B. The VHI score evaluates 5 parameters (vaginal elasticity, vaginal secretions, vaginal pH, epithelial mucous membrane, vaginal hydration) and to obtain a final score defining the degree of atrophy in the genitourinary tract by assigning a single score to each parameter. The minim score is 5 and the maxim is 25.
Time Frame
120 days
Title
Vestibular Trophism by Vestibular Health Score
Description
Vestibular Health Score (VHS) will be used by the Investigator evaluating 5 parameters (Petechiae, Pallor, Fragility, dryness, Erythema) and to obtain a final score defining the degree of atrophy. Each item is scored on a Likert scale between 0 =absent and 3 =severe. Total scores range from 0 to 15.
Time Frame
120 days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women affected by Genitourinary syndrome of menopause (GSM) with Vaginal dryness, burning/pain, dyspareunia, dysuria
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
menopausal women aged between 40 and 70 years old (defined as Absence of menstruation for 12 consecutive months).
women affected by Genitourinary syndrome of menopause (GSM) with Vaginal dryness, burning/pain, dyspareunia, dysuria.
women not treated with Replacement therapy with estrogen and progestogen (HT) or estrogen alone (ET) or selective estrogen receptor modulators (SERMS) in the last 3 months
Exclusion Criteria:
hypersensitivity to laser
clinically significant findings on physical examination
any chronic medical condition or psychologic disorder that per opinion of the Principal Investigator would make the patient ineligible for the study
vulvo-vestibular lesion not related with GSM
active vaginal or vulvar infections (e.g., herpes, candida, STIs)
prolapse beyond the hymen
subject has a history of scarring alteration (ie, keloid formation)
unknown past or active history of vaginal bleeding disorders
any condition or behavior indicating to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Filippo Murina, MD
Phone
+39 0263635420
Email
filippo.murina@asst-fbf-sacco.it
First Name & Middle Initial & Last Name or Official Title & Degree
Dionisio F Barattini, MD
Phone
+40774012684
Email
franco.barattini@tigermedgrp.com
Facility Information:
Facility Name
Ospedale dei Bambini V Buzzi
City
Milano
ZIP/Postal Code
20154
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filippo Buzzi", MD
Phone
+390263635420
Email
filippo.murina@asst-fbf-sacco.it
12. IPD Sharing Statement
Learn more about this trial
To Assess Signs and Symptoms in Women Affected by GSM After One Cycle of Pixel CO2-Alma Fractionated Laser
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