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

NCT07413705 | Recruiting FDA Device

• 1 other identifier: BTL-699_CTUS400
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 3

Brief 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

Keywords

Depressive Symptoms; Depression; Urinary Incontinence; Sexual Dysfunction; Sexual Function; ExoTMS; Perimenopause; Postmenopause; EMSELLA; EXOMIND

Outcome Measures

Primary Outcomes (1)

• Assessment of Change in Subjective Depressive Symptoms in Perimenopausal and Postmenopausal Women

  The change in the score obtained from the self-reported Patient Health Questionnaire-9 (PHQ-9). The baseline score will be compared to the 1-month follow-up score. The total score from this 9-item questionnaire ranges from 0 to 27, with higher scores indicating greater depression severity. Improvement is considered a decrease in the obtained score.

  15 months

Secondary Outcomes (8)

• Assessment of Change in Objective Symptoms of Depression in Perimenopausal and Postmenopausal Women

  15 months

• Assessment of Change in Sexual Function in Perimenopausal and Postmenopausal Women

  15 months

• Assessment of Change in Urinary Incontinence in Perimenopausal and Postmenopausal Women

  15 months

• Assessment of Change in Mental Well-Being in Perimenopausal and Postmenopausal Women

  15 months

• Assessment of Satisfaction

  15 months

Study Arms (2)

Active treatment with BTL-699-2 and HPM-6000UF

EXPERIMENTAL

Participants will receive active treatment (BTL-699-2 intensity: up to 70% of MT, HPM-6000UF intensity: up to 100%)

Device: EXOMIND (BTL-699-2) Active Treatment; Device: EMSELLA (HPM-6000UF) ActiveTreatment

Sham treatment with BTL-699-2 and HPM-6000UF

SHAM COMPARATOR

Participants will receive sham treatment (BTL-699-2 intensity: 1% of MT, HPM-6000UF intensity: 1%)

Device: EXOMIND (BTL-699-2) Sham Treatment; Device: EMSELLA (HPM-6000UF) Sham Treatment

Interventions

EXOMIND (BTL-699-2) Active Treatment DEVICE

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.

Also known as: ExoTMS

Active treatment with BTL-699-2 and HPM-6000UF

EMSELLA (HPM-6000UF) ActiveTreatment DEVICE

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.

Active treatment with BTL-699-2 and HPM-6000UF

EXOMIND (BTL-699-2) Sham Treatment DEVICE

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.

Also known as: ExoTMS

Sham treatment with BTL-699-2 and HPM-6000UF

EMSELLA (HPM-6000UF) Sham Treatment DEVICE

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.

Sham treatment with BTL-699-2 and HPM-6000UF

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Menopause defined as 12 consecutive months with no menses without an alternative medical cause or perimenopause defined as occurrence of ≥ 60 days of amenorrhea without an alternative medical cause
• Patient Health Questionnaire-9 (PHQ-9) pre-treatment score of ≥ 5
• Age ≥ 40 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 improvement of depressive symptoms and/or sexual function, 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
• Women of childbearing potential\* are required to use birth control measures during the whole duration of the study
• If applicable, subjects will be maintained on pre-study psychotherapeutic regime, and prescribed chronic medications at a stable therapeutic dosage for at least 1 month prior to study entry \*defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.

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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (3)

Luxury Psychiatry Clinic

Winter Garden, Florida, 34787, United States

RECRUITING

Aesthetic + Mind MD

Wellesley, Massachusetts, 02481, United States

RECRUITING

Vitality MD Inc

Toronto, Ontario, M5M3Y8, Canada

RECRUITING

MeSH Terms

Conditions

Depression; Urinary Incontinence; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: November 20, 2025
• Primary Completion (Estimated): December 11, 2026
• Study Completion (Estimated): December 11, 2026
• Last Updated: February 17, 2026

Record last verified: 2025-12

Locations

CA (1); US (2)