BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence in Postpartum and Early Post-Childbirth Women
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
1 other identifier
interventional
60
1 country
3
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2025
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 25, 2025
CompletedFirst Submitted
Initial submission to the registry
February 9, 2026
CompletedFirst Posted
Study publicly available on registry
February 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 11, 2026
February 17, 2026
December 1, 2025
1 year
February 9, 2026
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of Change in Self-Reported Symptoms of Depression in Postpartum Women and in Women up to Five Years after Childbirth
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.
15 months
Secondary Outcomes (9)
Assessment of Change in Clinician-Reported Symptoms of Depression in Postpartum Women and in Women up to Five Years after Childbirth
15 months
Assessment of Change in Self-Reported Maternity-Related Symptoms of Depression in Postpartum Women and in Women up to Five Years after Childbirth
15 months
Assessment of Change in Urinary Incontinence in Postpartum Women and in Women up to Five Years after Childbirth
15 months
Assessment of Change in Sexual Function in Postpartum Women and in Women up to Five Years after Childbirth
15 months
Assessment of Change in Mental Well-Being in Postpartum Women and in Women up to Five Years after Childbirth
15 months
- +4 more secondary outcomes
Study Arms (2)
Active treatment with BTL-699-2 and HPM-6000UF
EXPERIMENTALParticipants will receive active treatment (BTL-699-2 intensity: up to 70% of MT, HPM-6000UF intensity: up to 100%)
Sham treatment with BTL-699-2 and HPM-6000UF
SHAM COMPARATORParticipants will receive sham treatment (BTL-699-2 intensity: 1% of MT, HPM-6000UF intensity: 1%)
Interventions
Participants will receive six transcranial magnetic stimulation treatments with the BTL-699-2 device over the left dorsolateral prefrontal cortex. The intensity will be adjusted according to the subject's feedback, up to 70% of the individual's motor threshold. The treatments will be spaced 3 - 7 days apart.
Participants will receive six treatments with the HPM-6000UF device delivered to the pelvic floor musculature. The intensity will be set to 1%. The treatments will be spaced 3 - 7 days apart.
Participants will receive six treatments with the HPM-6000UF device delivered to the pelvic floor musculature. The intensity will be adjusted according to the subject's feedback, up to 100%. The treatments will be spaced 3 - 7 days apart.
Participants will receive six transcranial magnetic stimulation treatments with the BTL-699-2 device over the left dorsolateral prefrontal cortex. The intensity will be set to 1% of the individual's motor threshold. The treatments will be spaced 3 - 7 days apart.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Charak Center for Health & Wellness
Garfield Heights, Ohio, 44125, United States
Optimal Health Associates
Oklahoma City, Oklahoma, 73114, United States
Tricia Shimer, M.D., P.A.
Dallas, Texas, 75231, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2026
First Posted
February 17, 2026
Study Start
November 25, 2025
Primary Completion (Estimated)
December 11, 2026
Study Completion (Estimated)
December 11, 2026
Last Updated
February 17, 2026
Record last verified: 2025-12