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
This study uses a prospective, multi-center, two-arm, single-blinded, interventional study. The subjects will be enrolled and randomly assigned to two experimental study arms: the active group (Group A) and the sham group (Group B), in a ratio of 3:1. All enrolled participants will be treated (either active or sham) with both the BTL-699-2 and HPM-6000UF devices. Group A will receive active treatment (BTL-699-2 intensity: up to 70% of MT, HPM-6000UF intensity: up to 100%) and Group B, which receives sham treatment (BTL-699-2 intensity: 1% of MT, HPM-6000UF intensity: 1%). The Patient Health Questionnaire-9 (PHQ-9) will be administered to the subjects before the first treatment, at every treatment visit except the first, and at the two follow-up visits-1 month and 3 months after the final session. The 6-item Hamilton Depression Rating Scale (HAMD-6), International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), 6-item Female Sexual Function Index (FSFI-6), Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), and Columbia Suicide Severity Rating Scale-Screen version (CSSRS) will be administered to the subjects before the first treatment, after the last treatment, and at the two follow-up visits-1 month and 3 months after the final session. The Greene Climacteric Scale (GCS) will be administered at baseline The Therapy Comfort Questionnaire will be administered after the last treatment, while the Subject Satisfaction Questionnaire will be given after the last treatment and at both follow-up visits. The total expected duration of subject participation, from the baseline visit to study completion, is approximately five months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
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.
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.
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.
Luxury Psychiatry Clinic
Winter Garden, Florida, United States
RECRUITINGAesthetic + Mind MD
Wellesley, Massachusetts, United States
RECRUITINGVitality MD Inc
Toronto, Ontario, Canada
RECRUITINGAssessment 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.
Time frame: 15 months
Assessment of Change in Objective Symptoms of Depression in Perimenopausal and Postmenopausal Women
The change in the score obtained from the clinician-reported 6-item Hamilton Depression Rating Scale (HAMD-6). The baseline score will be compared to the 1-month follow-up score. The total score ranges from 0 to 22, with higher scores indicating greater depression severity. Improvement is considered a decrease in the obtained score.
Time frame: 15 months
Assessment of Change in Sexual Function in Perimenopausal and Postmenopausal Women
The change in sexual function obtained from the 6-item Female Sex administered at the baseline visit, at the last treatment visit and at both follow-up visits to evaluate the change in sexual function. The total score ranges from 2 to 30, with higher total score indicating better sexual function.
Time frame: 15 months
Assessment of Change in Urinary Incontinence in Perimenopausal and Postmenopausal Women
The change in the score obtained from the self-reported International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). The total score ranges from 0 to 21, with higher total score indicating greater symptom burden and impact.
Time frame: 15 months
Assessment of Change in Mental Well-Being in Perimenopausal and Postmenopausal Women
The change in the score obtained from the self-reported Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). The minimum scale score is 14 and the maximum is 70. Improvement is considered an increase in the obtained score. The WEMWBS will be filled out at baseline, at the last treatment visit, and at both follow-up visits.
Time frame: 15 months
Assessment of Satisfaction
Subject Satisfaction with treatment outcomes will be assessed using 5-point Likert Scale Subjects Satisfaction Questionnaire. The questionnaire will be administered after the last treatment, at the 1-month and 3-month follow-up visits. Responses to questions about satisfaction with the treatment outcomes will range from "strongly disagree" (1 point) to "strongly agree" (5 points). A higher score for each statement indicate better outcomes.
Time frame: 15 months
Assessment of Therapy Comfort
Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. The Therapy Comfort questionnaire will be administered after the last treatment. Therapy Comfort questionnaire consists of the question "I found the treatment comfortable", to which responses are based on a 5-point Likert scale (1 = "strongly disagree", and 5 = "strongly agree"). A higher score for the statement "I found the treatment comfortable" indicate higher therapy comfort.
Time frame: 15 months
Assessment of Pain During Therapy
The Therapy Comfort Questionnaire will be used to evaluate pain experienced during the treatment session. It will be administered after the stimulation of each location. The questionnaire includes a 10-point Numeric Analog Scale for pain (0 = no pain, 10 = worst possible pain). Lower scores on the Numeric Analog Scale indicate lower levels of pain.
Time frame: 15 months
Incidence of Treatment-Related Adverse Events
Monitoring of adverse reactions and side effects will be performed for the evaluation of safety of the combined treatment with the BTL-699-2 and HPM-6000UF devices for the improvement of depressive symptoms and sexual function and to identify side effects and adverse events associated with the study treatment.
Time frame: 15 months
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