Evaluating Combined BTL-699-2 and HPM-6000UF Devices to Improve Depression and Sexual Function in Perimenopausal and Postmenopausal Women

What this Trial Is About

This research aims to evaluate whether the combined use of the EXOMIND BTL-699-2 and EMSELLA HPM-6000UF devices can improve depressive symptoms, sexual function, and urinary incontinence in women who are perimenopausal or postmenopausal, aged 40 years and older, without other medical causes. The study uses a prospective, multi-center, randomized, single-blinded design with two groups to assess safety and efficacy over approximately five months. Participants are randomly assigned in a 31 ratio to either an active treatment group or a sham treatment group. The active group receives six sessions of transcranial magnetic stimulation using the BTL-699-2 device over the left dorsolateral prefrontal cortex at intensities up to 70% of their motor threshold, and six treatments with the HPM-6000UF device applied to pelvic floor muscles at intensities up to 100%. The sham group receives similar procedures at minimal intensities 1%. Treatments are spaced 3 to 7 days apart. During the study, participants complete several assessments including the Patient Health Questionnaire-9, Hamilton Depression Rating Scale, Greene Climacteric Scale, International Consultation on Incontinence Questionnaire, Female Sexual Function Index, Warwick-Edinburgh Mental Wellbeing Scale, Columbia Suicide Severity Rating Scale, Therapy Comfort Questionnaire, and Subject Satisfaction Questionnaire. These are completed at baseline, during treatment, and at follow-ups 1 month and 3 months post-treatment. Researchers monitor changes in depressive symptoms, sexual function, urinary incontinence, mental well-being, therapy comfort, satisfaction, and any treatment-related adverse events.

BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women