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

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.