University of Nove de Julho
Sandra Kalil Bussadori
The goal of this project is to evaluate the clinical response of patients with symptoms of genitourinary menopause syndrome after the application of photobiomodulation in the vagina and its introit. METHOD: In this randomized, double-blind, placebo-controlled study protocol, women over 50 years of age who are in the postmenopausal period (amenorrhea for at least 12 months, with no pathology involved) with one or more symptoms of PGS will be selected. Participants included in the study will be randomly divided into two groups: group A, which will receive photobiomodulation with a vaginal diode laser and its introit and group B (placebo) with the laser device turned off. Both treatments will be maintained for 4 consecutive weeks.The treatment group (n=30) will receive four consecutive applications, using laser diode DMC (808 nm), 4J per point, 100mW of power, 510mW/cm², beam area of 0.2cm², 8 sites in the external vagina, for the 40s in each site, once per week for 4 weeks. The Placebo Group (n=30) will be handled as treated, but with the laser turned off. Quality of life will be analyzed using the female sexual functioning index (FSFI-6), the urinary incontinence questionnaire (ICIQ-SF), the intensity of menopausal symptoms will be evaluated using a visual analogue scale (VAS), the vulvo vaginal atrophy will be measured by the Vaginal Health Index (VHI) and compared between groups. Also, the vaginal temperature will be measured using a thermal camera, as well as the pressure of the pelvic floor force (vaginal dynamometer) and a 1-hour Pad Test will be performed to quantify the urinary loss. The data will be tested for normality using the Shapiro Wilks test and, if they present a parametric distribution, they will be represented by means of their respective means and standard deviations.
Postmenopausal Symptoms
Photobiomodulation
Placebo Photobiomodulation
Phase 1
Phase 2
Study Type : | Interventional |
Estimated Enrollment : | 60 participants |
Masking : | Double |
Masking Description : | Neither the participant nor the outcome assessor will know to which group the participant belongs, seeing as laser application will be simulated in the placebo group. |
Primary Purpose : | Treatment |
Official Title : | Photobiomodulation in Post Menopause Genitourinary Syndrome - Study Protocol for a Randomized, Double-blind, Controlled Clinical Trial |
Actual Study Start Date : | October 30, 2022 |
Estimated Primary Completion Date : | June 30, 2023 |
Estimated Study Completion Date : | July 30, 2023 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Photobiomodulation group Participants in this group will receive photobiomodulation with a vaginal diode laser and its introit. |
Radiation: Photobiomodulation |
Placebo Comparator: Placebo group Participants in this group will receive simulated photobiomodulation, with the laser device turned off. |
Radiation: Placebo Photobiomodulation |
Ages Eligible for Study: | 50 Years to 70 Years |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.