About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- EXOMIND (BTL-699-2) ActiveTreatment
- EMSELLA (HPM-6000UF) ActiveTreatment
- EXOMIND (BTL-699-2) Sham Treatment
- EMSELLA (HPM-6000UF) Sham Treatment