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
BTL Industries Ltd.
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
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…
Eligibility
- Age range
- 22–60 years
- Sex
- Female
- Healthy volunteers
- No
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 treatm…
Interventions
- DeviceEXOMIND (BTL-699-2) ActiveTreatment
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.
- DeviceEMSELLA (HPM-6000UF) ActiveTreatment
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.
- DeviceEXOMIND (BTL-699-2) Sham Treatment
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.
- DeviceEMSELLA (HPM-6000UF) Sham Treatment
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.
Locations (3)
- Charak Center for Health & WellnessGarfield Heights, Ohio
- Optimal Health AssociatesOklahoma City, Oklahoma
- Tricia Shimer, M.D., P.A.Dallas, Texas