Combined EXOMIND and EMSELLA treatment for depression, urinary leakage, and sexual function in perimenopausal and postmenopausal women
Safety and Efficacy of the Combined BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women
This trial will test whether combining EXOMIND (BTL-699-2) brain stimulation with EMSELLA (HPM-6000UF) pelvic stimulation can improve mood, reduce urinary leakage, and boost sexual function in perimenopausal and postmenopausal women aged 40 and older.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years and up |
| Sex | Female |
| Sponsor | BTL Industries Ltd. Industry-sponsored |
| Locations | 3 sites (Winter Garden, Florida and 2 other locations) |
| Trial ID | NCT07413705 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multi-center, two-arm, single-blinded interventional study that randomizes participants 3:1 to active or sham treatment. All participants receive twelve sessions with both devices; the active group receives therapeutic intensities while the sham group receives minimal-intensity settings. Outcomes include repeated measures of depressive symptoms (PHQ-9, HAMD-6), urinary incontinence (ICIQ-UI SF), sexual function (FSFI-6), menopause symptoms (Greene Climacteric), well-being (WEMWBS), and safety/comfort questionnaires. Assessments occur before treatment, during treatment visits, after the final session, and at one- and three-month follow-ups.
Who should consider this trial
Good fit: Ideal candidates are women aged 40 or older who are perimenopausal or postmenopausal with a PHQ-9 score of 5 or higher, no alternative medical cause for their symptoms, able to undergo motor threshold testing, and willing to avoid other treatments during the study.
Not a fit: Women with alternative medical causes for their symptoms, those receiving concurrent treatments for depression or sexual dysfunction, women younger than 40, or those unable to tolerate or undergo motor threshold determination are unlikely to benefit from or qualify for this protocol.
Why it matters
Potential benefit: If effective, the combined device approach could offer a non-pharmacologic option to reduce depressive symptoms, improve urinary control, and enhance sexual function in perimenopausal and postmenopausal women.
How similar studies have performed: Brain electromagnetic stimulation (rTMS-like) has shown benefit for depression and EMSELLA pelvic electromagnetic therapy has shown benefit for urinary incontinence and sexual function separately, but combining these two devices in this population is novel and not well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Menopause defined as 12 consecutive months with no menses without an alternative medical cause or perimenopause defined as occurrence of ≥ 60 days of amenorrhea without an alternative medical cause
* Patient Health Questionnaire-9 (PHQ-9) pre-treatment score of ≥ 5
* Age ≥ 40 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 improvement of depressive symptoms and/or sexual function, 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
* Women of childbearing potential\* are required to use birth control measures during the whole duration of the study
* If applicable, subjects will be maintained on pre-study psychotherapeutic regime, and prescribed chronic medications at a stable therapeutic dosage for at least 1 month prior to study entry \*defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
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
* History or concurrent use of electroconvulsive therapy or vagus nerve stimulation
* 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
* Substance abuse
* Dependence 3 months prior
* 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
* Nursing
* Ongoing intake disorders such as bulimia or anorexia, or intake disorder in the past 12 months
* 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
Winter Garden, Florida and 2 other locations
- Luxury Psychiatry Clinic — Winter Garden, Florida, United States (Recruiting)
- Aesthetic + Mind MD — Wellesley, Massachusetts, United States (Recruiting)
- Vitality MD Inc — Toronto, Ontario, Canada (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.