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Safety and Efficacy of Combined BTL-699-2 and HPM-6000UF Devices for Improving Depression and Urinary Incontinence in Postpartum Women and Women up to Five Years After Childbirth
Led by BTL Industries Ltd. · Updated on 2026-02-17
60
Participants Needed
3
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating whether the combined use of the EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices can improve depressive symptoms and urinary incontinence in women who gave birth to a healthy, single infant between 2 and 60 months before joining the study. The study focuses on women aged 22 to under 60 years. It uses a prospective, multi-center, two-arm, single-blinded design to compare active versus sham treatments. Participants will be randomly assigned in a 3:1 ratio to receive either active or sham treatments with both devices. The active group will receive six transcranial magnetic stimulation treatments with the BTL-699-2 device over the left dorsolateral prefrontal cortex at intensities up to 70% of their motor threshold, and six treatments with the HPM-6000UF device to the pelvic floor muscles at intensities up to 100%. The sham group will receive similar treatments at minimal intensities (1%). Treatments are spaced 3 to 7 days apart. Participants will complete a series of questionnaires and scales before treatment, during treatment visits, after the last treatment, and at follow-ups 1 and 3 months after treatment ends. These assessments include depression scales, urinary incontinence questionnaires, sexual function indexes, mental wellbeing scales, and therapy comfort and satisfaction questionnaires. The total expected participation time is about five months, during which researchers will monitor changes in depressive symptoms, urinary incontinence, sexual function, mental wellbeing, therapy comfort, satisfaction, and any treatment-related adverse events.
CONDITIONS
Brief 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...
- Delivery of a healthy, singleton infant 2-60 months before enrollment
- Currently caring for or in regular contact with the child
- Patient Health Questionnaire-9 (PHQ-9) score of 5 or higher before treatment
- Age between 22 and 60 years
- Ability to determine motor threshold by finger contraction
- Willing to avoid other treatments for depression or urinary incontinence during the study
- Willing to follow study instructions and attend required visits
- Use birth control during the study if pregnancy is possible
- Stable psychotherapeutic or neuropsychiatric medication regimen for at least 1 month before study start, if applicable
You will not qualify if you...
- Presence of metallic objects in or near the head
- Implanted stimulators, defibrillators, neurostimulators, pacemakers, or electronic implants
- Metal implants and active or inactive implants near the head (e.g., deep brain stimulators, cochlear implants)
- Drug pumps
- Treatment application in the heart or head area
- History or tendency for seizures, including epilepsy and hypotonia
- Anticoagulation therapy
- Severe or life-threatening conditions
- 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 in the last 3 years
- Substance-induced depression or depression from medical conditions
- Certain psychiatric disorders including psychotic disorders, bipolar disorder, and borderline personality disorder
- Current substance abuse or dependence within 3 months
- History or 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 other condition that may pose risk or affect study participation as determined by investigators, including certain implants like aneurysm clips, stents, bullet fragments, or jewelry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Approximately 3 to 6 weeks
Participants receive six treatments with two devices, the BTL-699-2 and HPM-6000UF. Treatments are given over the left dorsolateral prefrontal cortex and pelvic floor musculature respectively. Treatments are spaced 3 to 7 days apart and the intensity varies by group assignment (active or sham).
6 treatment visits spaced 3 to 7 days apart
Duration - 3 months after the final treatment
Participants attend follow-up visits to assess symptoms of depression, urinary incontinence, sexual function, mental wellbeing, therapy comfort, and satisfaction after completing treatment.
2 follow-up visits at 1 month and 3 months after the last treatment
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
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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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