BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women

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

Conditions

• Depressive Symptoms
• Urinary Incontinence
• Sexual Dysfunction

Interventions

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• BTL Industries Ltd.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-20

Primary Completion

2026-12-11

Completion

2026-12-11

FDA Device

Yes

Countries

• United States
• Canada

Study Locations