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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTL-899 Treatments | Experimental | 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. |
|
| HPM-6000UF Treatments | Experimental | The HPM-6000UF device will induce pelvic floor muscle contractions. Six (6) treatments 2-4 days apart will be delivered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL-899 | Device | 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. |
| 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 |
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Inclusion Criteria:
Exclusion 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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contour Medical | Gilbert | Arizona | 85297 | United States | ||
| Julene B. Samuels |
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| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| HPM-6000UF | Device | The HPM-6000UF device will induce pelvic floor muscle contractions. Six (6) treatments 2-4 days apart will be delivered. |
|
| River Bluff |
| Kentucky |
| 40059 |
| United States |
| Southern Urogynecology | West Columbia | South Carolina | 29169 | United States |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |