Combined EXOMIND and EMSELLA therapy for postpartum depressive symptoms and urinary incontinence
Safety and Efficacy of the Combined BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence Among Postpartum Women and Women up to Five Years After Childbirth
This trial will test whether combined EXOMIND and EMSELLA device treatments can improve depressive symptoms and urinary incontinence in women aged 22–60 who delivered a healthy single infant 2–60 months ago.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 22 Years to 60 Years |
| Sex | Female |
| Sponsor | BTL Industries Ltd. Industry-sponsored |
| Locations | 3 sites (Garfield Heights, Ohio and 2 other locations) |
| Trial ID | NCT07413692 on ClinicalTrials.gov |
What this trial studies
This prospective, multi-center, randomized, single-blinded trial assigns participants 3:1 to active or sham combined-device treatment using EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF). Participants receive twelve treatment sessions and are evaluated with measures including PHQ-9 at each visit and additional scales (HAMD-6, EPDS, ICIQ-UI SF, FSFI-6, WEMWBS, CSSRS) before, after, and at 1- and 3-month follow-ups. The active arm receives up to 70% motor threshold intensity for EXOMIND and up to 100% for EMSELLA while the sham arm receives minimal intensity (1%) for both devices. The study tests whether combined neuromodulation and pelvic-floor electromagnetic therapy reduces depressive symptoms and urinary leakage compared with sham treatment.
Who should consider this trial
Good fit: Ideal candidates are women aged 22–60 who delivered a healthy singleton infant 2–60 months earlier, have a PHQ-9 score of ≥5, are involved in caregiving, can undergo motor threshold determination, and can commit to the treatment schedule and study restrictions.
Not a fit: Patients unlikely to benefit include those outside the age or postpartum window, with PHQ-9 scores below 5, pregnant or unable to use birth control during the study, unable to determine motor threshold, or already receiving other non-study neuromodulation treatments.
Why it matters
Potential benefit: If successful, the combined device treatment could reduce postpartum depressive symptoms and urinary incontinence, potentially improving mood, daily function, and pelvic floor control.
How similar studies have performed: Individual therapies like repetitive transcranial magnetic stimulation for depression and EMSELLA for urinary incontinence have shown benefit in prior studies, but combining these two device therapies in postpartum women is a novel approach with limited direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Delivery of a healthy, singleton infant 2-60 months before enrollment in the study * Current involvement in caregiving or regular contact with the child in question * Patient Health Questionnaire-9 (PHQ-9) pre-treatment score of ≥ 5 * Age ≥ 22, but ≤ 60 years * Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the finger * Subjects willing and able to abstain from partaking in any treatments other than the pre-procedure therapy regime for the treatment of depressive symptoms and/or urinary incontinence, including non-invasive brain stimulation treatments other than the study procedure during study participation * Willingness to comply with study instructions and to return to the clinic for the required visits * Subjects are required to use birth control measures throughout the study if there is a reasonable possibility they could become pregnant during the study * If applicable, subjects will be maintained on a pre-study psychotherapeutic regimen and/or prescribed neuropsychiatric medications at a stable therapeutic dosage for at least 1 month prior to study entry Exclusion Criteria: * Metallic objects in or near the head * rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 12 in (30 cm) of the treatment coil\* * Implanted stimulator devices, implanted defibrillators, implanted neurostimulators * Cardiac pacemakers * Electronic implants * Metal implants * rTMS devices are contraindicated for use in patients who have active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, ocular implants and vagus nerve stimulators. Contraindicated use could result in serious injury or death. * Drug pumps * Application in the heart area * Application of HPM-6000UF in the head area * Persons with a tendency to seizure (e.g., persons suffering from hypotonia and epilepsy) * Anticoagulation therapy * Severe or life-threatening condition * Pulmonary insufficiency * Heart disorders * Renal insufficiency * Decompensated\*\* hemorrhagic conditions * Decompensated\*\* blood coagulation disorders * Decompensated\*\* cardiovascular diseases * Malignant tumor or benign tumor * Fever * Pregnancy Study specific: * Active suicidal intent * History of suicide attempts in the last 3 years before enrollment in the study * Substance-induced depression or depression secondary to a general medical condition * Diagnosis of seasonal affective disorder, psychotic disorder including schizoaffective disorder or current psychotic symptoms, major depression with psychotic features, bipolar disorder, borderline personality disorder * Current episodes of substance abuse * Substance dependence 3 months before enrollment in the study * History or concurrent use of electroconvulsive therapy or vagus nerve stimulation * Neurological disorders, including a history of seizures, cerebrovascular disease, primary or secondary tumors in CNS, cerebral aneurysm, dementia, or movement disorders * History of increased intracranial pressure or head trauma * Any other disease or condition at the investigator's discretion that may pose risk to the patient or compromise the study * Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes. Failure to follow this restriction could result in serious injury or death. Certain exceptions apply to mouth implants such as standard amalgam dental fillings, single post dental implants, dental bridge work, and braces. If these items are present, the therapy can still be administered. \*\*By means of decompensation, it means a patient with a proven medical history of the decompensated health condition and long-term medication. Patients who use certain medications only for preventive purposes, without any proven previous health condition failure are not considered contraindicated.
Where this trial is running
Garfield Heights, Ohio and 2 other locations
- Charak Center for Health & Wellness — Garfield Heights, Ohio, United States (Recruiting)
- Optimal Health Associates — Oklahoma City, Oklahoma, United States (Recruiting)
- Tricia Shimer, M.D., P.A. — Dallas, Texas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.