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

Part of paid clinical trials in Winter Garden, Florida.

Sponsor
BTL Industries Ltd.
Study ID
NCT07413705
Status
Recruiting
Apply to this trial

Conditions

  • Depressive Symptoms
  • Sexual Dysfunction
  • Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
40 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.
  • 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.

Study Details

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

Key Dates

Start date
Nov 20, 2025
Status verified
Dec 2025
Primary completion
Dec 11, 2026
Completion
Dec 11, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active treatment with BTL-699-2 and HPM-6000UF
    Participants will receive active treatment (BTL-699-2 intensity: up to 70% of MT, HPM-6000UF intensity: up to 100%)
  • Sham Comparator: Sham treatment with BTL-699-2 and HPM-6000UF
    Participants will receive sham treatment (BTL-699-2 intensity: 1% of MT, HPM-6000UF intensity: 1%)

Primary Outcome Measure

Assessment of Change in Subjective Depressive Symptoms in Perimenopausal and Postmenopausal Women [ Time Frame: 15 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Luxury Psychiatry ClinicWinter GardenFlorida34787
Michelle Dees, MD
[email protected]
(407) 603-0925
Aesthetic + Mind MDWellesleyMassachusetts02481
Omotola Tsarumi, MD
[email protected]
(617) 668-1239

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By research site
Luxury Psychiatry Clinic· Winter Garden, FLAesthetic + Mind MD· Wellesley, MA

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