Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence in Postpartum and Early Post-Childbirth Women

NCT07413692 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 60 participants
Start Date 2025-11-25
Est. Completion 2026-12-11
Phase NA

Sponsor

BTL Industries

9 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BTL Industries, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07413692 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Ohio, Oklahoma, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07413692?

This trial is sponsored by BTL Industries, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial