NCT05557799

Photobiomodulation in Post Menopause Genitourinary Syndrome

Status unknown Phase 1, PHASE2 Last updated 28 September 2022

What this trial tests

Phase 1, PHASE2 trial testing Photobiomodulation in Postmenopausal Symptoms in 60 participants. Status unknown.

Timeline

30 October 2022

Primary endpoint
30 June 2023

30 July 2023

Quick facts

Lead sponsor	University of Nove de Julho
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	30 October 2022
Primary completion	30 June 2023
Estimated completion	30 July 2023

Drugs / interventions tested

• Photobiomodulation
• Placebo Photobiomodulation

Conditions studied

• Postmenopausal Symptoms — all drugs for Postmenopausal Symptoms →

Sponsor

University of Nove de Julho

Who can join

Adults 50 to 70, female only, with Postmenopausal Symptoms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Photobiomodulation in post menopause genitourinary syndrome-Study protocol for a randomized, double-blind, controlled clinical protocol.
   Pereira SRDS, Mesquita-Ferrari RA, Salviatto LTC, Bezerra CDDS, et al · · 2024 · cited 2× · PMID 39621728 · DOI 10.1371/journal.pone.0313324