Actively Recruiting
BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence in Postpartum and Early Post-Childbirth Women
Led by BTL Industries Ltd. · Updated on 2026-02-17
60
Participants Needed
3
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence in Postpartum and Early Post-Childbirth Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Delivered a healthy, single infant 2 to 60 months before enrolling
- Currently involved in caregiving or regular contact with the child
- Patient Health Questionnaire-9 pre-treatment score of 5 or higher
- Aged 22 to under 60 years
- Ability to determine motor threshold for treatment
- Willing and able to avoid other depression or urinary incontinence treatments during study
- Willing to follow study instructions and attend required visits
- Use birth control if there is a chance of pregnancy during the study
- If applicable, stable psychotherapeutic or neuropsychiatric medication dosage for at least 1 month before study
You will not qualify if you...
- Presence of metallic objects in or near the head
- Implanted stimulators, defibrillators, neurostimulators, pacemakers, electronic implants, or metal implants
- Use of rTMS devices contraindicated with certain implants including deep brain stimulators, cochlear implants, ocular implants, vagus nerve stimulators
- Drug pumps
- Application of HPM-6000UF or treatments in the head or heart area
- History or tendency for seizures or epilepsy
- Anticoagulation therapy
- Severe or life-threatening conditions including pulmonary, heart, or renal insufficiency
- Decompensated hemorrhagic, blood coagulation, or cardiovascular diseases
- Malignant or benign tumors
- Fever or pregnancy
- Active suicidal intent or suicide attempts within last 3 years
- Substance-induced depression or depression from a medical condition
- Diagnosis of seasonal affective disorder, psychotic or bipolar disorders, borderline personality disorder
- Current substance abuse or dependence within 3 months
- History or current use of electroconvulsive therapy or vagus nerve stimulation
- Neurological disorders including seizures, cerebrovascular disease, brain tumors, aneurysm, dementia, or movement disorders
- History of increased intracranial pressure or head trauma
- Any condition posing risk or compromising study at investigator's discretion (e.g., certain implants, aneurysm clips, metal fragments)
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Trial Site Locations
Total: 3 locations
1
Charak Center for Health & Wellness
Garfield Heights, Ohio, United States, 44125
Actively Recruiting
2
Optimal Health Associates
Oklahoma City, Oklahoma, United States, 73114
Actively Recruiting
3
Tricia Shimer, M.D., P.A.
Dallas, Texas, United States, 75231
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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