Depressive SymptomsNCT07413692
BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence in Postpartum and Early Post-Childbirth Women
A study testing EXOMIND (BTL-699-2) ActiveTreatment and EMSELLA (HPM-6000UF) ActiveTreatment in people with Depressive Symptoms and Urinary Incontinence, run by BTL Industries Ltd. at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 60 years, women only
- Conditions the study is for
- Depressive Symptoms, Urinary Incontinence
- What is being tested?
- EXOMIND (BTL-699-2) ActiveTreatment and EMSELLA (HPM-6000UF) ActiveTreatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Nov 2025to 27 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 34Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tricia Shimer, M.D., P.A.
Dallas, Texas, 75231
Charak Center for Health & Wellness
Garfield Heights, Ohio, 44125
Optimal Health Associates
Oklahoma City, Oklahoma, 73114
About this study
Official title: 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
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
Read the detailed description
This study uses a prospective, multi-center, two-arm, single-blinded, interventional study.
The subjects will be enrolled and randomly assigned to two experimental study arms: the active group (Group A) and the sham group (Group B), in a ratio of 3:1. All enrolled participants will be treated (either active or sham) with both the BTL-699-2 and HPM-6000UF devices. Group A will receive active treatment (BTL-699-2 intensity: up to 70% of MT, HPM-6000UF intensity: up to 100%) and Group B, which receives sham treatment (BTL-699-2 intensity: 1% of MT, HPM-6000UF intensity: 1%).
The Patient Health Questionnaire-9 (PHQ-9) will be administered to the subjects before the first treatment, at every treatment visit except the first, and at the two follow-up visits-1 month and 3 months after the final session.
The 6-item Hamilton Depression Rating Scale (HAMD-6), Edinburgh Postnatal Depression Scale (EPDS), International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), 6-item Female Sexual Function Index (FSFI-6), Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), and Columbia Suicide Severity Rating Scale-Screen version (CSSRS) will be administered to the subjects before the first treatment, after the last treatment, and at the two follow-up visits-1 month and 3 months after the final session.
The Therapy Comfort Questionnaire will be administered after the last treatment, while the Subject Satisfaction Questionnaire will be given after the last treatment and at both follow-up visits.
The total expected duration of subject participation, from the baseline visit to study completion, is approximately five months.
- Conditions
- Depressive Symptoms, Urinary Incontinence
- Being tested
- EXOMIND (BTL-699-2) ActiveTreatment, EMSELLA (HPM-6000UF) ActiveTreatment, EXOMIND (BTL-699-2) Sham Treatment, EMSELLA (HPM-6000UF) Sham Treatment
- Keywords
- Depressive Symptoms, Depression, Urinary Incontinence, Incontinence, Postpartum, EMSELLA, ExoTMS, EXOMIND
- Medical subject headings
- Depression, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXOMIND (BTL-699-2) ActiveTreatmentDevice
Also called ExoTMS
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.
EMSELLA (HPM-6000UF) ActiveTreatmentDevice
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.
EXOMIND (BTL-699-2) Sham TreatmentDevice
Also called ExoTMS
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.
EMSELLA (HPM-6000UF) Sham TreatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment with BTL-699-2 and HPM-6000UF | Experimental | Participants will receive active treatment (BTL-699-2 intensity: up to 70% of MT, HPM-6000UF intensity: up to 100%) Receives: Device: EXOMIND (BTL-699-2) ActiveTreatment; Device: EMSELLA (HPM-6000UF) ActiveTreatment |
| Sham treatment with BTL-699-2 and HPM-6000UF | Sham comparator | Participants will receive sham treatment (BTL-699-2 intensity: 1% of MT, HPM-6000UF intensity: 1%) Receives: Device: EXOMIND (BTL-699-2) Sham Treatment; Device: EMSELLA (HPM-6000UF) Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The change in the score obtained from the clinician-reported 6-item Hamilton Depression Rating Scale (HAMD-6). The baseline score will be compared to the 1-month follow-up score. The total score ranges from 0 to 22, with higher scores indicating greater depression severity. Improvement is considered a decrease in the obtained score.
Measured: 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
The change in the score obtained from the self-reported Edinburgh Postnatal Depression Scale (EPDS). The total score from this 10-item questionnaire ranges from 0 to 30, with higher scores indicating greater depression severity. Improvement is considered a decrease in the obtained score.
Measured: 15 months
Assessment of Change in Urinary Incontinence in Postpartum Women and in Women up to Five Years after Childbirth
The change in the score obtained from the self-reported International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). The total score ranges from 0 to 21, with higher total score indicating greater symptom burden and impact.
Measured: 15 months
Assessment of Change in Sexual Function in Postpartum Women and in Women up to Five Years after Childbirth
The change in the score obtained from the self-reported 6-item Female Sexual Function Index (FSFI-6). The total score ranges from 2 to 30, with lower scores indicating poorer sexual function.
Measured: 15 months
Assessment of Change in Mental Well-Being in Postpartum Women and in Women up to Five Years after Childbirth
The change in the score obtained from the self-reported Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). The minimum scale score is 14 and the maximum is 70. Improvement is considered an increase in the obtained score. The WEMWBS will be filled out at baseline, at the last treatment visit, and at both follow-up visits.
Measured: 15 months
Assessment of Satisfaction
Subject Satisfaction with treatment outcomes will be assessed using 5-point Likert Scale Subjects Satisfaction Questionnaire. The questionnaire will be administered after the last treatment, at the 1-month and 3-month follow-up visits. Responses to questions about satisfaction with the treatment outcomes will range from "strongly disagree" (1 point) to "strongly agree" (5 points). A higher score for each statement indicate better outcomes.
Measured: 15 months
Assessment of Therapy Comfort
Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. The Therapy Comfort questionnaire will be administered after the last treatment. Therapy Comfort questionnaire consists of the question "I found the treatment comfortable", to which responses are based on a 5-point Likert scale (1 = "strongly disagree", and 5 = "strongly agree"). A higher score for the statement "I found the treatment comfortable" indicate higher therapy comfort.
Measured: 15 months
Incidence of Treatment-related Adverse Events
Monitoring of adverse reactions and side effects will be performed for the evaluation of safety of the combined treatment with the BTL-699-2 and HPM-6000UF devices for the improvement of depressive symptoms and urinary incontinence and to identify side effects and adverse events associated with the study treatment.
Measured: 15 months
Assessment of Pain During Therapy
The Therapy Comfort Questionnaire will be used to evaluate pain experienced during the treatment session. It will be administered after the stimulation of each location. The questionnaire includes a 10-point Numeric Analog Scale for pain (0 = no pain, 10 = worst possible pain). Lower scores on the Numeric Analog Scale indicate lower levels of pain.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start25 Nov 2025
- Primary completion27 Aug 2026
- Study completion27 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413692
- Sponsor's protocol ID
- BTL-699_CTUS500
- Status last verified
- Dec 2025
- First submitted
- 9 Feb 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07413692
- Acronym / sponsor ID
- BTL-699_CTUS500
- Conditions
- Depressive Symptoms, Urinary Incontinence
- Keywords
- Depressive Symptoms, Depression, Urinary Incontinence, Incontinence, Postpartum, EMSELLA, ExoTMS, EXOMIND
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 27 Aug 2026 (actual)
- Study completion
- 27 Aug 2026 (actual)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study uses a prospective, multi-center, two-arm, single-blinded, interventional study.
The subjects will be enrolled and randomly assigned to two experimental study arms: the active group (Group A) and the sham group (Group B), in a ratio of 3:1. All enrolled participants will be treated (either active or sham) with both the BTL-699-2 and HPM-6000UF devices. Group A will receive active treatment (BTL-699-2 intensity: up to 70% of MT, HPM-6000UF intensity: up to 100%) and Group B, which receives sham treatment (BTL-699-2 intensity: 1% of MT, HPM-6000UF intensity: 1%).
The Patient Health Questionnaire-9 (PHQ-9) will be administered to the subjects before the first treatment, at every treatment visit except the first, and at the two follow-up visits-1 month and 3 months after the final session.
The 6-item Hamilton Depression Rating Scale (HAMD-6), Edinburgh Postnatal Depression Scale (EPDS), International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), 6-item Female Sexual Function Index (FSFI-6), Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), and Columbia Suicide Severity Rating Scale-Screen version (CSSRS) will be administered to the subjects before the first treatment, after the last treatment, and at the two follow-up visits-1 month and 3 months after the final session.
The Therapy Comfort Questionnaire will be administered after the last treatment, while the Subject Satisfaction Questionnaire will be given after the last treatment and at both follow-up visits.
The total expected duration of subject participation, from the baseline visit to study completion, is approximately five months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment with BTL-699-2 and HPM-6000UF | Experimental | Device: EXOMIND (BTL-699-2) ActiveTreatment, Device: EMSELLA (HPM-6000UF) ActiveTreatmentParticipants 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 comparator | Device: EXOMIND (BTL-699-2) Sham Treatment, Device: EMSELLA (HPM-6000UF) Sham TreatmentParticipants will receive sham treatment (BTL-699-2 intensity: 1% of MT, HPM-6000UF intensity: 1%) |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXOMIND (BTL-699-2) ActiveTreatmentAlso: ExoTMSParticipants 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. | Device | Active treatment with BTL-699-2 and HPM-6000UF |
| EMSELLA (HPM-6000UF) ActiveTreatmentParticipants 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. | Device | Active treatment with BTL-699-2 and HPM-6000UF |
| EXOMIND (BTL-699-2) Sham TreatmentAlso: ExoTMSParticipants 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. | Device | Sham treatment with BTL-699-2 and HPM-6000UF |
| EMSELLA (HPM-6000UF) Sham TreatmentParticipants 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. | Device | Sham treatment with BTL-699-2 and HPM-6000UF |
Primary outcome
Assessment of Change in Self-Reported Symptoms of Depression in Postpartum Women and in Women up to Five Years after Childbirth
Time frame: 15 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.
9 secondary outcomes
Assessment of Change in Clinician-Reported Symptoms of Depression in Postpartum Women and in Women up to Five Years after Childbirth
Time frame: 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
Time frame: 15 months
Assessment of Change in Urinary Incontinence in Postpartum Women and in Women up to Five Years after Childbirth
Time frame: 15 months
Assessment of Change in Sexual Function in Postpartum Women and in Women up to Five Years after Childbirth
Time frame: 15 months
Assessment of Change in Mental Well-Being in Postpartum Women and in Women up to Five Years after Childbirth
Time frame: 15 months
Assessment of Satisfaction
Time frame: 15 months
Assessment of Therapy Comfort
Time frame: 15 months
Incidence of Treatment-related Adverse Events
Time frame: 15 months
Assessment of Pain During Therapy
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXOMIND (BTL-699-2) ActiveTreatment and EMSELLA (HPM-6000UF) ActiveTreatment in people with Depressive Symptoms and Urinary Incontinence, run by BTL Industries Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Change in Self-Reported Symptoms of Depression in Postpartum Women and in Women up to Five Years after Childbirth (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.