EFFECT OF PHOTOBIOMODULATION ON GENITOURINARY MENOPAUSE SYNDROME: BLIND, RANDOMIZED AND CONTROLLED CLINICAL TRIAL
climacteric, physiological sexual dysfunction, urinary incontinence, microbiota.
Introduction: Aging is a universal and inevitable process that is arousing interest in several areas around the world. In women, in addition to the physiological changes resulting from age, others occur due to ovarian failure that culminates in menopause. During menopause, hormone levels decrease and, as a consequence, a spectrum of genitourinary symptoms and signs called Menopause Genitourinary Syndrome (MGS) is observed. MGS is associated with numerous urogenital changes, which implies pain or discomfort and post-coital bleeding, changes in the vagina microbiota, favoring infections and atrophy in the urothelium of the bladder trigone and urethra, leading to urological implications such as: dysuria, urinary incontinence and urinary urgency. Conservative interventions such as photobiomodulation have been recommended, however, there are no studies that prove their effectiveness.
Objective: To evaluate the therapeutic effect of photobiomodulation on genitourinary symptoms in climacteric women.
Methods: a randomized controlled, parallel, open, three-arm clinical treatment trial will be carried out. Patients will be divided into three groups: photobiomodulation group (FBM, n=18), photobiomodulation and pelvic floor muscle training group (FBM+PFMT, n=18) and control group (orientation, n=18). The photobiomodulation dose will be 25J/cm2 and the pelvic floor training will be based on the existing and published protocol. Initially, all women will be evaluated by collecting sociodemographic, gynecological-obstetric and urological information. In the physical examination, vaginal atrophy (primary outcome) and pressure of the pelvic floor muscles will be evaluated, urinary symptoms by the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), sexual function by the Female Sexual Function Index (FSFI), vaginal microbiota and perception of improvement in clinical condition as secondary outcomes. These evaluations described above will be carried out at T0 (before the intervention), T1 (after 8 sessions), T2 (after 16 sessions) and T3 (one month after T2). Interventions of the isolated photobiomodulation group and associated with pelvic floor muscle training will occur twice a week, totaling 16 sessions.
Expected Results: It is expected that non-pharmacological approaches may be beneficial for the symptoms of MGS, especially in women with contraindications to the use of hormones, or who prefer not to use them. However, it is expected that they can also be used as adjunctive or substitute therapy for any patient.