Combination Treatment With BTL-899 and HPM-6000UF Devices II

Study Overview
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Brief Summary
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This study will evaluate the clinical efficacy of the BTL-899 and HPM-6000UF devices in combination for non-invasive strengthening of the core muscles and overall improvement in quality of life in female patients after childbirth.

Detailed Description
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This study will evaluate the clinical efficacy of the BTL-899 and HPM-6000UF devices in combination for non-invasive strengthening of the core muscles and overall improvement in quality of life in female patients after childbirth. The study is a prospective, multicenter single-arm, open-label, interventional study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete seven (7) treatment visits and two (2) follow-up visits - 1 month and 3 months after the final treatment. At the baseline visit, medical history will be assessed. Inclusion and exclusion criteria will be verified, and informed consent will be signed. Digital photographs will be taken, waist circumference will be measured, abdominal muscle strength will be measured with a pressure biofeedback device. The two devices will be used separately in two different treatments. However, one treatment visit can comprise both treatments. The BTL-899 will be applied over the abdomen, and the device will induce visible muscle contractions along with mild heating of the muscles. Four (4) treatments five (5) to (10) days apart will be delivered. The HPM-6000UF device will induce pelvic floor muscle contractions. Six (6) treatments 2-4 days apart will be delivered. There will be three (3) visits where both treatments will be applied consecutively, starting with BTL-899, followed by the therapy with HPM-6000UF.

Official Title
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Evaluation of the Combination Treatment With BTL-899 and HPM-6000UF Devices for Abdominal and Pelvic Floor Muscle Strengthening and Overall Improvement in Quality of Life in Patients After Childbirth

Conditions
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Muscle Weakness

Intervention / Treatment
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* Device: BTL-899
* Device: HPM-6000UF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female subjects aged 22 years or older who have given birth to a baby 6 to 60 months prior to their enrolment in the study seeking treatment for strengthening their pelvic floor and abdominal muscles Having a body mass index (BMI) less than 35 kg/m2 Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form. Subjects willing and able to abstain from partaking in any concurrent treatments on abdomen and pelvic floor other than the study procedures during study participation. Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs taken. Exclusion Criteria: Ongoing Pregnancy, nursing or IVF procedure Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators) Metal implants in the treated area Drug pumps Malignant tumor Pulmonary insufficiency Injured or otherwise impaired muscles in the treated area Cardiovascular diseases Disturbance of temperature or pain perception Hemorrhagic conditions Septic conditions and empyema Acute inflammations in the treated area Systemic or local infection such as osteomyelitis and tuberculosis Contagious skin disease Elevated body temperature Poor healing and unhealed wounds in the treatment area Following recent surgical procedures when muscle contraction may disrupt the healing process Graves' disease Scars in the treatment area Metal containing Intrauterine Device (IUD)

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BTL-899 Treatments<br>The BTL-899 will be applied over the abdomen, and the device will induce visible muscle contractions along with mild heating of the muscles. Four (4) treatments once a week will be delivered. | Device: BTL-899<br>* The BTL-899 will be applied over the abdomen, and the device will induce visible muscle contractions along with mild heating of the muscles. Four (4) treatments once a week will be delivered.<br>|
| Experimental: HPM-6000UF Treatments<br>The HPM-6000UF device will induce pelvic floor muscle contractions. Six (6) treatments 2-4 days apart will be delivered. | Device: HPM-6000UF<br>* The HPM-6000UF device will induce pelvic floor muscle contractions. Six (6) treatments 2-4 days apart will be delivered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of core muscles strength measured by pressure biofeedback device | Change in core muscles strength measured by pressure biofeedback device. The maximal pressure before and after the study therapy will be compared for each subject, according to the study phase. Through the change in pressure, the change in strength will be evaluated. | 5 months | 
| Assessment of subject's quality of life based on Subject Satisfaction and Experience | Change in subject's quality of life based on Subject Satisfaction and Experience Questionnaire. The subjects will answer questions about their lifestyle where the best possible answer is Strongly agree and the worst is Strongly disagree. | 5 months |