Study of EXOMIND and EMSELLA for Postpartum Depression and Urinary Incontinence
This study is looking at whether combining two devices, EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF), can help improve symptoms of depression and urinary incontinence in women after childbirth. You might be able to join if you are a woman between 22 and 60 years old, delivered a healthy baby 2 to 60 months ago, and have a certain level of depressive symptoms (PHQ-9 score of 5 or more). The study will measure changes in your self-reported depression symptoms over 15 months to see if the treatment is successful. The current recruitment status for this study is unclear.
- Study design
- This is a multi-center study where 60 participants will be randomly assigned to either receive the active treatments or sham (inactive) treatments, with more people getting the active treatment. Participants will not know if they are receiving the active or sham treatment.
- What's involved
- You would undergo twelve treatments, spaced 3-7 days apart, and complete several questionnaires before, during, and after treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your depression symptoms will be assessed for up to 15 months after the study begins. Other assessments will occur 1 and 3 months after your final treatment session.
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NCT07413692
BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence in Postpartum and Early Post-Childbirth Women
Recruiting
NAAges 22–60InterventionalTreatmentBTL Industries Ltd.
~60 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:EXOMIND (BTL-699-2) ActiveTreatmentEMSELLA (HPM-6000UF) ActiveTreatmentEXOMIND (BTL-699-2) Sham TreatmentEMSELLA (HPM-6000UF) Sham Treatment
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of Change in Self-Reported Symptoms of Depression in Postpartum Women and in Women up to Five Years after Childbirth
Measured over 15 months
Conditions
Where it's being run
3 sites across 3 statesOhio1
Oklahoma1
Texas1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
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.
What this trial measures
- Assessment of Change in Self-Reported Symptoms of Depression in Postpartum Women and in Women up to Five Years after Childbirth15 months
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.