Study of Combined BTL-699-2 and HPM-6000UF Devices to Improve Depression and Urinary Incontinence in Women 2 to 60 Months After Childbirth

What this Trial Is About

Researchers are evaluating whether the combined use of the EXOMIND BTL-699-2 and EMSELLA HPM-6000UF devices can improve depressive symptoms and urinary incontinence in women who gave birth to a healthy, single infant between 2 and 60 months before joining the study. The study focuses on women aged 22 to under 60 years. It uses a prospective, multi-center, two-arm, single-blinded design to compare active versus sham treatments. Participants will be randomly assigned in a 31 ratio to receive either active or sham treatments with both devices. The active group will receive six transcranial magnetic stimulation treatments with 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 to the pelvic floor muscles at intensities up to 100%. The sham group will receive similar treatments at minimal intensities 1%. Treatments are spaced 3 to 7 days apart. Participants will complete a series of questionnaires and scales before treatment, during treatment visits, after the last treatment, and at follow-ups 1 and 3 months after treatment ends. These assessments include depression scales, urinary incontinence questionnaires, sexual function indexes, mental wellbeing scales, and therapy comfort and satisfaction questionnaires. The total expected participation time is about five months, during which researchers will monitor changes in depressive symptoms, urinary incontinence, sexual function, mental wellbeing, therapy comfort, satisfaction, and any treatment-related adverse events.

BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence in Postpartum and Early Post-Childbirth Women