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 urinary incontinence in women who delivered a healthy, singleton infant 2-60 months before enrollment in the study and are aged 22 years and older, but under the age of 60 years. 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 Edinburgh Postnatal Depression 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
Delivery of a healthy, singleton infant 2-60 months before enrollment in the study
Current involvement in caregiving or regular contact with the child in question
Patient Health Questionnaire-9 (PHQ-9) pre-treatment score of ≥ 5
Age ≥ 22, but ≤ 60 years
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) ActiveTreatment
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 Self-Reported Symptoms of Depression in Postpartum Women and in Women up to Five Years after Childbirth
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 Clinician-Reported Symptoms of Depression in Postpartum Women and in Women up to Five Years after Childbirth
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 Self-Reported Maternity-Related Symptoms of Depression in Postpartum Women and in Women up to Five Years after Childbirth
The change in the score obtained from the self-reported Edinburgh Postnatal Depression Scale (EPDS). The total score from this 10-item questionnaire ranges from 0 to 30, with higher scores indicating greater depression severity. Improvement is considered a decrease in the obtained score.
Assessment of Change in Urinary Incontinence in Postpartum Women and in Women up to Five Years after Childbirth
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 Sexual Function in Postpartum Women and in Women up to Five Years after Childbirth
The change in the score obtained from the self-reported 6-item Female Sexual Function Index (FSFI-6). The total score ranges from 2 to 30, with lower scores indicating poorer sexual function.
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