BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence in Postpartum and Early Post-Childbirth Women
Trial Parameters
Brief Summary
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
Inclusion Criteria: * 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 * 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 * Subjects willing and able to abstain from partaking in any treatments other than the pre-procedure therapy regime for the treatment of depressive symptoms and/or urinary incontinence, including non-invasive brain stimulation treatments other than the study procedure during study participation * Willingness to comply with study instructions and to return to the clinic for the required visits * Subjects are required to use birth control measures throughout the study if there is a reasonable possibility they could become pregn