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NCT07413692 · ClinicalTrials.gov registry record · NA
BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence in Postpartum and Early Post-Childbirth 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
NCT07413692 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.
The verdict
NCT07413692, 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 urinary incontinence in women who delivered a healthy, singleton infant 2-60 months before enrollment in the study and are aged 22 years and older, but under the age of 60 years. 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 Edinburgh Postnatal Depression 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 Studied
Interventions
- DEVICE EMSELLA (HPM-6000UF) ActiveTreatment
- DEVICE EXOMIND (BTL-699-2) Sham Treatment
- DEVICE EMSELLA (HPM-6000UF) Sham Treatment
- DEVICE EXOMIND (BTL-699-2) ActiveTreatment
Study Locations (3)
Ohio
- Charak Center for Health & Wellness - Garfield Heights
Oklahoma
- Optimal Health Associates - Oklahoma City
Texas
- Tricia Shimer, M.D., P.A. - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-11-25 |
| Est. Completion | 2026-12-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07413692
The ClinicalTrials.gov registry entry for NCT07413692 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 60 other Depressive Symptoms trials with a reported enrollment target (77% lower). The listed sponsor is BTL Industries, which has 40 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Depressive Symptoms appearing as the primary indexed condition, and to 4 interventions - of which EMSELLA (HPM-6000UF) ActiveTreatment is the first listed.
NCT07413692 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Ohio, Oklahoma, Texas.
Frequently Asked Questions
What is clinical trial NCT07413692 about?
NCT07413692 is a clinical study titled "BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence in Postpartum and Early Post-Childbirth 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 urinary incontinence in women who delivered a healthy, singleton infant 2-60 months before enrollment in the study and are age...
What is the current status of trial NCT07413692?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-11-25. Estimated completion is 2026-12-11.
What conditions does trial NCT07413692 study?
This clinical trial studies the following conditions: Depressive Symptoms, Urinary Incontinence.
What interventions are being tested in trial NCT07413692?
The interventions under investigation include: EMSELLA (HPM-6000UF) ActiveTreatment (DEVICE), EXOMIND (BTL-699-2) Sham Treatment (DEVICE), EMSELLA (HPM-6000UF) Sham Treatment (DEVICE), EXOMIND (BTL-699-2) ActiveTreatment (DEVICE).
Who is sponsoring clinical trial NCT07413692?
This trial is sponsored by BTL Industries, which has 40 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07413692 being conducted?
This trial has 3 study locations across Ohio, Oklahoma, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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