To Assess Signs and Symptoms in Women Affected by GSM After One Cycle of Pixel CO2-Alma Fractionated Laser

NCT ID: NCT05156502

Last Updated: 2021-12-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-30
• Study Completion Date: 2022-08-31

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.

Conditions

Genitourinary Syndrome of Menopause (GSM); Vaginal Dryness; Burning; Pain; Dyspareunia; Dysuria

Keywords

Genitourinary syndrome of menopause (GSM); Fractionated Laser; Vaginal dryness.; dyspareunia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fractionated Laser

Group Type: EXPERIMENTAL

Fractionated Laser (Pixel CO2-Alma)

Intervention Type: DEVICE

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.

Fractionated.Laser

Group Type: ACTIVE_COMPARATOR

Fractionated Laser (Pixel CO.2-Alma)

Intervention Type: DEVICE

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.

Interventions

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 and vestibule, following the IFU of the device.

Intervention Type: DEVICE

Fractionated Laser (Pixel CO.2-Alma)

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Opera CRO, a TIGERMED Group Company

OTHER

Sponsor Role: collaborator

Dr. Filippo Murina

OTHER

Sponsor Role: lead

Responsible Party

Dr. Filippo Murina

Responsabile Servizio di Patologia del tratto genitale inferiore

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ospedale dei Bambini V Buzzi

Milan, , Italy

Countries

Italy

Central Contacts

Filippo Murina, MD

Role: CONTACT

Phone: +39 0263635420

Email: filippo.murina@asst-fbf-sacco.it

Dionisio F Barattini, MD

Role: CONTACT

Phone: +40774012684

Email: franco.barattini@tigermedgrp.com

Facility Contacts

Filippo Buzzi", MD

Role: primary

Other Identifiers

SSSM-2020-03.1

Identifier Type: -

Identifier Source: org_study_id