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Photobiomodulation in post menopause genitourinary syndrome-Study protocol for a randomized, double-blind, controlled
Silvia Regina Dos Santos Pereira1, Raquel Agnelli Mesquita-Ferrari1, Luciana Toledo Costa Salviatto1
1Post Graduation Program in Biophotonics Medicine, Universidade Nove de Julho, São Paulo, SP, Brazil.
Plos One
|December 2, 2024
Summary
This study protocol evaluates photobiomodulation for Genitourinary Syndrome of Menopause (GSM) symptoms in postmenopausal women. It aims to improve quality of life and reduce urinary, genital, and sexual symptoms through a laser treatment protocol.
Area of Science:
- Gynecology
- Women's Health
- Medical Technology
Background:
- Genitourinary Syndrome of Menopause (GSM) affects many postmenopausal women, causing urinary, genital, and sexual dysfunction due to estrogen deficit.
- Brazilian women spend a significant portion of their lives post-menopause, experiencing symptoms like vaginal dryness, dyspareunia, and urinary incontinence.
- Existing treatments like fractionated photothermolysis and radiofrequency have been explored for GSM symptom improvement.
Purpose of the Study:
- To establish a protocol for assessing the clinical efficacy of photobiomodulation in treating Genitourinary Syndrome of Menopause (GSM).
- To evaluate the impact of vulvar photobiomodulation on the quality of life and specific symptoms of GSM in postmenopausal women.
Main Methods:
- A randomized, double-blind, placebo-controlled study involving 60 postmenopausal women (age >50) with GSM symptoms.
- The treatment group (n=30) received weekly vulvar photobiomodulation with an 808 nm laser for four weeks; the placebo group (n=30) received sham treatment.
- Outcomes were measured using validated questionnaires (FSFI-6, ICIQ-SF), Visual Analogue Scale (VAS), Vaginal Health Index (VHI), vaginal temperature, pelvic floor pressure, and a 1-hour Pad Test.
Main Results:
- Data collection is ongoing, with assessments performed before the first treatment and after the final irradiation.
- The study aims to demonstrate significant improvements in quality of life and symptom reduction for women with GSM.
Conclusions:
- This protocol provides a rigorous framework for evaluating photobiomodulation as a potential treatment for Genitourinary Syndrome of Menopause.
- Successful outcomes are anticipated to lead to enhanced quality of life and diminished symptoms for affected women.
