Clinical trial NCT05156502: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Genitourinary Syndrome of Menopause (GSM)
Vaginal Dryness
Burning
Pain
Dyspareunia
Dysuria
Keywords: Genitourinary syndrome of menopause (GSM)
Fractionated Laser
Vaginal dryness.
dyspareunia
Lead sponsor: ASST Fatebenefratelli Sacco
Sponsor class: OTHER
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2021-12-14
Enrollment: 70
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Vaginal dryness by Visual Analogue Scale
timeFrame: 120 days
measure: Burning/pain by Visual Analogue Scale
timeFrame: 120 days
measure: Dyspareunia by Visual Analogue Scale
timeFrame: 120 days
measure: Pain/sensitivity to touch at Swab test by Visual Analogue Scale.
timeFrame: 120 days
measure: Sexual Function by Female Sexual Function Index
timeFrame: 120 days
measure: Vulval Pain by Vulval Pain Functional Questionnaire
timeFrame: 120 days
measure: Incidence of Treatment-Emergent Adverse Events/ Adverse Device Events/ Serious Adverse Events/ Serious Adverse Device Events [Safety and Tolerability]
timeFrame: up to 120 days
Secondary outcomes:
measure: Vestibular Trophism by Vaginal Health Index
timeFrame: 120 days
measure: Vestibular Trophism by Vestibular Health Score
timeFrame: 120 days
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale dei Bambini V Buzzi
Study officials:
References: