The goal of this clinical trial is to evaluate if the combined treatment with EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices is able to improve depressive symptoms and sexual function in women who are perimenopausal or postmenopausal without an alternative medical cause before enrollment in the study and are aged 40 years and older. The main question it aims to answer is: Does the combined treatment with EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices improve depressive symptoms and urinary incontinence? Participants will be asked to:
Undergo twelve treatments Complete the Patient Health Questionnaire-9 Complete the 6-item Hamilton Depression Rating Scale Complete the Greene Climacteric Scale Complete the Therapy Comfort Questionnaire Complete the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form Complete the Female Sexual Function Index Complete the Warwick-Edinburgh Mental Wellbeing Scale Complete the Columbia Suicide Severity Rating Scale-Screen version Complete the Subject Satisfaction Questionnaire Complete the Therapy Comfort Questionnaire
Menopause defined as 12 consecutive months with no menses without an alternative medical cause or perimenopause defined as occurrence of ≥ 60 days of amenorrhea without an alternative medical cause
Patient Health Questionnaire-9 (PHQ-9) pre-treatment score of ≥ 5
Age ≥ 40 years
Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the finger
Metallic objects in or near the head
rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 12 in (30 cm) of the treatment coil*
Implanted stimulator devices, implanted defibrillators, implanted neurostimulators
Cardiac pacemakers
Parallel
EXOMIND (BTL-699-2) Active Treatment
DeviceParticipants will receive six transcranial magnetic stimulation treatments with the BTL-699-2 device over the left dorsolateral prefrontal cortex. The intensity will be adjusted according to the subject's feedback, up to 70% of the individual's motor threshold. The treatments will be spaced 3 - 7 days apart.
EMSELLA (HPM-6000UF) ActiveTreatment
DeviceParticipants will receive six treatments with the HPM-6000UF device delivered to the pelvic floor musculature. The intensity will be adjusted according to the subject's feedback, up to 100%. The treatments will be spaced 3 - 7 days apart.
EXOMIND (BTL-699-2) Sham Treatment
DeviceParticipants will receive six transcranial magnetic stimulation treatments with the BTL-699-2 device over the left dorsolateral prefrontal cortex. The intensity will be set to 1% of the individual's motor threshold. The treatments will be spaced 3 - 7 days apart.
EMSELLA (HPM-6000UF) Sham Treatment
DeviceParticipants will receive six treatments with the HPM-6000UF device delivered to the pelvic floor musculature. The intensity will be set to 1%. The treatments will be spaced 3 - 7 days apart.
Assessment of Change in Subjective Depressive Symptoms in Perimenopausal and Postmenopausal Women
The change in the score obtained from the self-reported Patient Health Questionnaire-9 (PHQ-9). The baseline score will be compared to the 1-month follow-up score. The total score from this 9-item questionnaire ranges from 0 to 27, with higher scores indicating greater depression severity. Improvement is considered a decrease in the obtained score.
Assessment of Change in Objective Symptoms of Depression in Perimenopausal and Postmenopausal Women
The change in the score obtained from the clinician-reported 6-item Hamilton Depression Rating Scale (HAMD-6). The baseline score will be compared to the 1-month follow-up score. The total score ranges from 0 to 22, with higher scores indicating greater depression severity. Improvement is considered a decrease in the obtained score.
Assessment of Change in Sexual Function in Perimenopausal and Postmenopausal Women
The change in sexual function obtained from the 6-item Female Sex administered at the baseline visit, at the last treatment visit and at both follow-up visits to evaluate the change in sexual function. The total score ranges from 2 to 30, with higher total score indicating better sexual function.
Assessment of Change in Urinary Incontinence in Perimenopausal and Postmenopausal Women
The change in the score obtained from the self-reported International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). The total score ranges from 0 to 21, with higher total score indicating greater symptom burden and impact.
Assessment of Change in Mental Well-Being in Perimenopausal and Postmenopausal Women
The change in the score obtained from the self-reported Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). The minimum scale score is 14 and the maximum is 70. Improvement is considered an increase in the obtained score. The WEMWBS will be filled out at baseline, at the last treatment visit, and at both follow-up visits.
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