BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence in Postpartum and Early Post-Childbirth Women
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Depressive Symptoms, Urinary Incontinence
In brief
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
Key facts
- Study ID
- NCT07413692
- Run by
- BTL Industries Ltd.
- People needed
- 60
- Starts
- 2025-11-25
- Expected to finish
- 2026-12-11
- Last updated by the study team
- 2026-02-17
Who can join
Age: 22 and older, up to 60. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Charak Center for Health & Wellness — Garfield Heights, Ohio, United States (enrolling)
- Optimal Health Associates — Oklahoma City, Oklahoma, United States (enrolling)
- Tricia Shimer, M.D., P.A. — Dallas, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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