RecruitingNot ApplicableNCT07413692

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


Sponsor

BTL Industries Ltd.

Enrollment

60 participants

Start Date

Nov 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 22 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests two non-invasive devices — BTL-699-2 (a brain stimulation device) and HPM-6000UF (a pelvic floor muscle stimulation device) — to see if they can improve depression symptoms and bladder leakage (urinary incontinence) in women who have recently given birth or are in the early postpartum period. **You may be eligible if...** - You are between 22 and 60 years old - You gave birth to a healthy, single baby between 2 and 60 months ago - You are still involved in caring for that child - You have at least mild depression symptoms (PHQ-9 score of 5 or above) - You are not currently using any other treatments for depression or bladder leakage **You may NOT be eligible if...** - You have metal implants in or near your head, a pacemaker, or implanted brain/nerve stimulators - You have a seizure disorder or epilepsy - You have active suicidal intent or attempted suicide in the past 3 years - You have been diagnosed with bipolar disorder, psychotic disorder, or borderline personality disorder - You are currently using substances or were substance-dependent in the past 3 months - You have neurological disorders, a history of head trauma, or increased intracranial pressure - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEXOMIND (BTL-699-2) ActiveTreatment

Participants will receive six transcranial magnetic stimulation treatments with the BTL-699-2 device over the left dorsolateral prefrontal cortex. The intensity will be adjusted according to the subject's feedback, up to 70% of the individual's motor threshold. The treatments will be spaced 3 - 7 days apart.

DEVICEEMSELLA (HPM-6000UF) ActiveTreatment

Participants will receive six treatments with the HPM-6000UF device delivered to the pelvic floor musculature. The intensity will be adjusted according to the subject's feedback, up to 100%. The treatments will be spaced 3 - 7 days apart.

DEVICEEXOMIND (BTL-699-2) Sham Treatment

Participants will receive six transcranial magnetic stimulation treatments with the BTL-699-2 device over the left dorsolateral prefrontal cortex. The intensity will be set to 1% of the individual's motor threshold. The treatments will be spaced 3 - 7 days apart.

DEVICEEMSELLA (HPM-6000UF) Sham Treatment

Participants will receive six treatments with the HPM-6000UF device delivered to the pelvic floor musculature. The intensity will be set to 1%. The treatments will be spaced 3 - 7 days apart.


Locations(3)

Charak Center for Health & Wellness

Garfield Heights, Ohio, United States

Optimal Health Associates

Oklahoma City, Oklahoma, United States

Tricia Shimer, M.D., P.A.

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07413692


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