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

NCT05156502 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-12-14

No results posted yet for this study

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

Interventions

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 and vestibule, following the IFU of the device.

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.

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • Dr. Filippo Murina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-30
Primary Completion
2022-05-31
Completion
2022-08-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05156502 on ClinicalTrials.gov