Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:26 AM
Study NCT ID:
NCT07413692
Status:
RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence in Postpartum and Early Post-Childbirth Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Change in Self-Reported Symptoms of Depression in Postpartum Women and in Women up to Five Years after Childbirth', 'timeFrame': '15 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Assessment of Change in Clinician-Reported Symptoms of Depression in Postpartum Women and in Women up to Five Years after Childbirth', 'timeFrame': '15 months', 'description': '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.'}, {'measure': 'Assessment of Change in Self-Reported Maternity-Related Symptoms of Depression in Postpartum Women and in Women up to Five Years after Childbirth', 'timeFrame': '15 months', 'description': '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.'}, {'measure': 'Assessment of Change in Urinary Incontinence in Postpartum Women and in Women up to Five Years after Childbirth', 'timeFrame': '15 months', 'description': '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.'}, {'measure': 'Assessment of Change in Sexual Function in Postpartum Women and in Women up to Five Years after Childbirth', 'timeFrame': '15 months', 'description': '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.'}, {'measure': 'Assessment of Change in Mental Well-Being in Postpartum Women and in Women up to Five Years after Childbirth', 'timeFrame': '15 months', 'description': '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.'}, {'measure': 'Assessment of Satisfaction', 'timeFrame': '15 months', 'description': '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.'}, {'measure': 'Assessment of Therapy Comfort', 'timeFrame': '15 months', 'description': '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.'}, {'measure': 'Incidence of Treatment-related Adverse Events', 'timeFrame': '15 months', 'description': '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.'}, {'measure': 'Assessment of Pain During Therapy', 'timeFrame': '15 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Depressive Symptoms', 'Depression', 'Urinary Incontinence', 'Incontinence', 'Postpartum', 'EMSELLA', 'ExoTMS', 'EXOMIND'], 'conditions': ['Depressive Symptoms', 'Urinary Incontinence']}, 'descriptionModule': {'briefSummary': '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:\n\nUndergo 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', 'detailedDescription': 'This study uses a prospective, multi-center, two-arm, single-blinded, interventional study.\n\nThe 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%).\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nThe total expected duration of subject participation, from the baseline visit to study completion, is approximately five months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Delivery of a healthy, singleton infant 2-60 months before enrollment in the study\n* Current involvement in caregiving or regular contact with the child in question\n* Patient Health Questionnaire-9 (PHQ-9) pre-treatment score of ≥ 5\n* Age ≥ 22, but ≤ 60 years\n* 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\n* 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\n* Willingness to comply with study instructions and to return to the clinic for the required visits\n* Subjects are required to use birth control measures throughout the study if there is a reasonable possibility they could become pregnant during the study\n* 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\n\nExclusion Criteria:\n\n* Metallic objects in or near the head\n* 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\\*\n* Implanted stimulator devices, implanted defibrillators, implanted neurostimulators\n* Cardiac pacemakers\n* Electronic implants\n* Metal implants\n* 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.\n* Drug pumps\n* Application in the heart area\n* Application of HPM-6000UF in the head area\n* Persons with a tendency to seizure (e.g., persons suffering from hypotonia and epilepsy)\n* Anticoagulation therapy\n* Severe or life-threatening condition\n* Pulmonary insufficiency\n* Heart disorders\n* Renal insufficiency\n* Decompensated\\*\\* hemorrhagic conditions\n* Decompensated\\*\\* blood coagulation disorders\n* Decompensated\\*\\* cardiovascular diseases\n* Malignant tumor or benign tumor\n* Fever\n* Pregnancy\n\nStudy specific:\n\n* Active suicidal intent\n* History of suicide attempts in the last 3 years before enrollment in the study\n* Substance-induced depression or depression secondary to a general medical condition\n* Diagnosis of seasonal affective disorder, psychotic disorder including schizoaffective disorder or current psychotic symptoms, major depression with psychotic features, bipolar disorder, borderline personality disorder\n* Current episodes of substance abuse\n* Substance dependence 3 months before enrollment in the study\n* History or concurrent use of electroconvulsive therapy or vagus nerve stimulation\n* Neurological disorders, including a history of seizures, cerebrovascular disease, primary or secondary tumors in CNS, cerebral aneurysm, dementia, or movement disorders\n* History of increased intracranial pressure or head trauma\n* Any other disease or condition at the investigator's discretion that may pose risk to the patient or compromise the study\n\n * 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."}, 'identificationModule': {'nctId': 'NCT07413692', 'briefTitle': 'BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence in Postpartum and Early Post-Childbirth Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'BTL Industries Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'BTL-699_CTUS500'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active treatment with BTL-699-2 and HPM-6000UF', 'description': 'Participants will receive active treatment (BTL-699-2 intensity: up to 70% of MT, HPM-6000UF intensity: up to 100%)', 'interventionNames': ['Device: EXOMIND (BTL-699-2) ActiveTreatment', 'Device: EMSELLA (HPM-6000UF) ActiveTreatment']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham treatment with BTL-699-2 and HPM-6000UF', 'description': 'Participants will receive sham treatment (BTL-699-2 intensity: 1% of MT, HPM-6000UF intensity: 1%)', 'interventionNames': ['Device: EXOMIND (BTL-699-2) Sham Treatment', 'Device: EMSELLA (HPM-6000UF) Sham Treatment']}], 'interventions': [{'name': 'EXOMIND (BTL-699-2) ActiveTreatment', 'type': 'DEVICE', 'otherNames': ['ExoTMS'], 'description': "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.", 'armGroupLabels': ['Active treatment with BTL-699-2 and HPM-6000UF']}, {'name': 'EMSELLA (HPM-6000UF) ActiveTreatment', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['Active treatment with BTL-699-2 and HPM-6000UF']}, {'name': 'EXOMIND (BTL-699-2) Sham Treatment', 'type': 'DEVICE', 'otherNames': ['ExoTMS'], 'description': "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.", 'armGroupLabels': ['Sham treatment with BTL-699-2 and HPM-6000UF']}, {'name': 'EMSELLA (HPM-6000UF) Sham Treatment', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Sham treatment with BTL-699-2 and HPM-6000UF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44125', 'city': 'Garfield Heights', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rakesh Ranjan, MD', 'role': 'CONTACT', 'email': 'rranjan@charakresearch.com', 'phone': '(216) 587-6727'}], 'facility': 'Charak Center for Health & Wellness', 'geoPoint': {'lat': 41.417, 'lon': -81.60596}}, {'zip': '73114', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Noel Williams, MD', 'role': 'CONTACT', 'email': 'nwilliams@optimalhealthassociates.com', 'phone': '(405) 715-4496'}], 'facility': 'Optimal Health Associates', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tricia Shimer, MD', 'role': 'CONTACT', 'email': 'tricia.shimer@gmail.com', 'phone': '(469) 214-4390'}], 'facility': 'Tricia Shimer, M.D., P.A.', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BTL Industries Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}