New combo therapy aims to tackle postpartum depression and incontinence without drugs
NCT ID NCT07413692
First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This study is testing whether two devices used together can help new mothers with both depression and urinary incontinence. One device uses magnetic pulses to stimulate brain areas linked to mood, while the other strengthens pelvic floor muscles with electromagnetic energy. Sixty women who gave birth 2 to 60 months ago will receive six sessions of each treatment. Researchers will track changes in depression scores and bladder control over one month.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Transcranial magnetic stimulation (TMS) and high-intensity focused electromagnetic (HIFEM) pelvic floor therapy
- What this could lead to
- If successful, this combined treatment could offer a non-drug option to ease both depressive symptoms and urinary incontinence in women after childbirth.
- What could go wrong
- This is a small, early-stage trial with no control group, so results may not be conclusive. The devices are non-invasive but may cause discomfort or fail to improve symptoms.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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30 people
The number who actually took part.
- Started
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Nov 2025
- Finished
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Aug 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 60 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Charak Center for Health & Wellness
Garfield Heights, Ohio, 44125, United States
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Optimal Health Associates
Oklahoma City, Oklahoma, 73114, United States
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Tricia Shimer, M.D., P.A.
Dallas, Texas, 75231, United States
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Other studies related to the condition(s) this trial covers.
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