Use of ultrasound energy in the treatment of vaginal changes after menopause

INTERVENTION: This is a randomized, controlled, two‐arm, double‐blind clinical trial involving 66 women who had been postmenopausal for up to 10 years and had vaginal atrophy. The participants were randomly assigned by computer, in a 1:1 ratio, to one of two groups. In the treatment group, 33 women received a single vaginal application of High‐Intensity Focused Ultrasound energy (HIFU). In the simulated control group (Sham), 33 women underwent the same procedure, but with a lower amount of energy, considered insufficient to produce the expected therapeutic effect. The procedure was performed in an outpatient setting, lasted approximately 30 minutes, and did not require anesthesia or prior preparation. Neither the participants nor the physician who performed the procedure knew which group each woman had been assigned to. The pathologist responsible for analyzing the biopsy samples was also unaware of the group allocation. Assessments were performed approximately 15 days before the procedure and at 3 and 6 months after treatment. They included a gynecological examination, assessment of vaginal health, and questionnaires evaluating sexual function and urinary and vaginal symptoms, as well as the removal of a small tissue sample from the vaginal wall for microscopic analysis of tissue changes related to vaginal atrophy. Before enrollment in the study, postmenopausal status was confirmed by blood tests measuring follicle‐stimulating hormone (FSH) and estradiol levels. A cervical cancer screening test (Pap smear) was also performed CONDITION: Atrophic vaginitis; Postmenopause ; Women's Health N01.400.900 PRIMARY OUTCOME: Histomorphological changes in vaginal tissue were assessed by microscopic analysis of biopsy specimens stained with hematoxylin and eosin and picrosirius, considering vaginal epithelial thickness, the percentage of type I and type III collagen fibers, inflammatory infiltrate, and vascularization. Inflammatory infiltrate and vascularization were classified as mild, moderate, or severe. Assessments were performed before the intervention and at three and six months after the procedure, with comparisons between the high‐intensity focused ultrasound group and the simulated‐procedure control group; INCLUSION CRITERIA: Participants who have been postmenopausal for a maximum of 10 years, with laboratory confirmation defined as FSH maior ou igual a 30 mIU/mL and estradiol (E2) menor que 24 pg/mL, and presenting signs and symptoms of genitourinary atrophy; negative cervical cytology (Pap smear) for neoplasia, performed within the routine screening interval recommended by the Brazilian Ministry of Health/INCA; absence of active genital infections SECONDARY OUTCOME: Change in pelvic floor muscle strength, assessed using the modified Oxford scale before the intervention and at three and si Xmonths after the procedure, with comparison between the high‐intensity focused ultrasound group and the simulated‐procedure control group Change in sexual function, assessed by the total score on the Female Sexual Function Inde Xbefore the intervention and at three and si Xmonths after the procedure, with comparisons between the high‐intensity focused ultrasound group and the simulated‐procedure control group Change in the severity of clinical symptoms, including vaginal dryness, dyspareunia, urinary urgency, nocturia, and stress urinary incontinence, assessed before the intervention and at three and si Xmonths after the procedure, with comparison between the high‐intensity focused ultrasound group and the simulated‐procedure control group Change in urinary and vaginal symptoms related to genitourinary syndrome of menopause, assessed using the score of the symptoms of urogenital atrophy questionnaire before the intervention and at three and si Xmonths after the procedure, with comparisons between the high‐intensity focused ultrasound group and the simulated‐procedure control group ; Change in vaginal health status, assessed using the Vaginal Health Inde XScore before the intervention and at three and si Xmonths after the procedure, with comparison between the high‐intensity focused ultrasound group and the simulated‐procedure control group Change in vaginal pH, measured using a pH indicator strip before the intervention and at three and si Xmonths after the procedure, with comparison between the high‐intensity focused ultrasound group and the simulated‐procedure control group ; Participant satisfaction after the procedure, assessed using a Likert scale at three and si Xmonths, with comparisons between the high‐intensity focused ultrasound group and the simulated‐procedure control group ;