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BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women
Sponsor: BTL Industries Ltd.
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 sexual function in women who are perimenopausal or postmenopausal without an alternative medical cause before enrollment in the study and are aged 40 years and older. 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 Greene Climacteric 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
Official title: Safety and Efficacy of the Combined BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women
Key Details
Gender
FEMALE
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-11-20
Completion Date
2026-12-11
Last Updated
2026-02-17
Healthy Volunteers
No
Interventions
EXOMIND (BTL-699-2) Active 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 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.
EMSELLA (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.
EXOMIND (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.
EMSELLA (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)
Luxury Psychiatry Clinic
Winter Garden, Florida, United States
Aesthetic + Mind MD
Wellesley, Massachusetts, United States
Vitality MD Inc
Toronto, Ontario, Canada