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NCT07413705 · ClinicalTrials.gov registry record · NA
BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women
A NA study of Depressive Symptoms and Urinary Incontinence, sponsored by BTL Industries.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT07413705: Recruiting NA study of Depressive Symptoms and Urinary Incontinence, sponsored by BTL Industries.
NCT07413705 is a NA study of Depressive Symptoms and Urinary Incontinence that is actively recruiting participants, run by BTL Industries. The registered enrollment target is 60 participants, below the 261-participant average among 60 other Depressive Symptoms trials with a reported enrollment target (77% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07413705, a NA study of Depressive Symptoms and Urinary Incontinence, is actively recruiting participants, sponsored by BTL Industries.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study 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
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE EXOMIND (BTL-699-2) Active Treatment
- DEVICE EMSELLA (HPM-6000UF) ActiveTreatment
- DEVICE EXOMIND (BTL-699-2) Sham Treatment
- DEVICE EMSELLA (HPM-6000UF) Sham Treatment
Study Locations (3)
Florida
- Luxury Psychiatry Clinic - Winter Garden
Massachusetts
- Aesthetic + Mind MD - Wellesley
Ontario
- Vitality MD Inc - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-11-20 |
| Est. Completion | 2026-12-11 |
| Phase | NA |
What NCT07413705 shows while recruiting
NCT07413705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 261-participant average among 60 other Depressive Symptoms trials with a reported enrollment target (77% lower).
The record links to 3 conditions, with Depressive Symptoms appearing as the primary indexed condition, and to 4 interventions - of which EXOMIND (BTL-699-2) Active Treatment is the first listed.
NCT07413705 reports a single indexed study location in Florida, Massachusetts, Ontario.
Frequently Asked Questions
What is clinical trial NCT07413705 about?
NCT07413705 is a clinical study titled "BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women". 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 th...
What is the current status of trial NCT07413705?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-11-20. Estimated completion is 2026-12-11.
What conditions does trial NCT07413705 study?
This clinical trial studies the following conditions: Depressive Symptoms, Urinary Incontinence, Sexual Dysfunction.
What interventions are being tested in trial NCT07413705?
The interventions under investigation include: EXOMIND (BTL-699-2) Active Treatment (DEVICE), EMSELLA (HPM-6000UF) ActiveTreatment (DEVICE), EXOMIND (BTL-699-2) Sham Treatment (DEVICE), EMSELLA (HPM-6000UF) Sham Treatment (DEVICE).
Who is sponsoring clinical trial NCT07413705?
This trial is sponsored by BTL Industries, which has 40 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07413705 being conducted?
This trial has 3 study locations across Florida, Massachusetts, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07413705's enrollment target sits among peer trials
60 42nd of 60 higher than 15 of 60 other Depressive Symptoms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depressive Symptoms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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