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

Safety and Efficacy of the Combined BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence Among Postpartum Women and Women up to Five Years After Childbirth

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

This study uses a prospective, multi-center, two-arm, single-blinded, interventional study.

The subjects will be enrolled and randomly assigned to two experimental study arms: the active group (Group A) and the sham group (Group B), in a ratio of 3:1. All enrolled participants will be treated (either active or sham) with both the BTL-699-2 and HPM-6000UF devices. Group A will receive active treatment (BTL-699-2 intensity: up to 70% of MT, HPM-6000UF intensity: up to 100%) and Group B, which receives sham treatment (BTL-699-2 intensity: 1% of MT, HPM-6000UF intensity: 1%).

The Patient Health Questionnaire-9 (PHQ-9) will be administered to the subjects before the first treatment, at every treatment visit except the first, and at the two follow-up visits-1 month and 3 months after the final session.

The 6-item Hamilton Depression Rating Scale (HAMD-6), Edinburgh Postnatal Depression Scale (EPDS), International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), 6-item Female Sexual Function Index (FSFI-6), Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), and Columbia Suicide Severity Rating Scale-Screen version (CSSRS) will be administered to the subjects before the first treatment, after the last treatment, and at the two follow-up visits-1 month and 3 months after the final session.

The Therapy Comfort Questionnaire will be administered after the last treatment, while the Subject Satisfaction Questionnaire will be given after the last treatment and at both follow-up visits.

The total expected duration of subject participation, from the baseline visit to study completion, is approximately five months.

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 pregnant during the study
• If applicable, subjects will be maintained on a pre-study psychotherapeutic regimen and/or prescribed neuropsychiatric medications at a stable therapeutic dosage for at least 1 month prior to study entry

Exclusion Criteria:

• 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
• Electronic implants
• Metal implants
• rTMS devices are contraindicated for use in patients who have active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, ocular implants and vagus nerve stimulators. Contraindicated use could result in serious injury or death.
• Drug pumps
• Application in the heart area
• Application of HPM-6000UF in the head area
• Persons with a tendency to seizure (e.g., persons suffering from hypotonia and epilepsy)
• Anticoagulation therapy
• Severe or life-threatening condition
• Pulmonary insufficiency
• Heart disorders
• Renal insufficiency
• Decompensated** hemorrhagic conditions
• Decompensated** blood coagulation disorders
• Decompensated** cardiovascular diseases
• Malignant tumor or benign tumor
• Fever
• Pregnancy

Study specific:

• Active suicidal intent

• History of suicide attempts in the last 3 years before enrollment in the study

• Substance-induced depression or depression secondary to a general medical condition

• Diagnosis of seasonal affective disorder, psychotic disorder including schizoaffective disorder or current psychotic symptoms, major depression with psychotic features, bipolar disorder, borderline personality disorder

• Current episodes of substance abuse

• Substance dependence 3 months before enrollment in the study

• History or concurrent use of electroconvulsive therapy or vagus nerve stimulation

• Neurological disorders, including a history of seizures, cerebrovascular disease, primary or secondary tumors in CNS, cerebral aneurysm, dementia, or movement disorders

• History of increased intracranial pressure or head trauma

• Any other disease or condition at the investigator's discretion that may pose risk to the patient or compromise the study

  • Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes. Failure to follow this restriction could result in serious injury or death. Certain exceptions apply to mouth implants such as standard amalgam dental fillings, single post dental implants, dental bridge work, and braces. If these items are present, the therapy can still be administered. **By means of decompensation, it means a patient with a proven medical history of the decompensated health condition and long-term medication. Patients who use certain medications only for preventive purposes, without any proven previous health condition failure are not considered contraindicated.