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The objective of the study is to evaluate the safety and efficacy of Abdominal EMS (Electrical Muscle Stimulation) on AWR (Abdominal Wall Restoration) in Post - Partum Women
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMS treatment | Experimental | Subjects will undergo treatment with EMS and measurements |
|
| Control | No Intervention | Subjects will undergo measurements only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMS device | Device | EMS treatment will be performed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in inter-recti distance (IRD), measured via Magnetic Resonance Imaging. | Up to 5 subjects will undergo MRI to evaluate effect of the treatment | 1 month |
| Change in inter-recti distance (IRD), measured via UltraSound Imaging to evaluate effect of the treatment | 1 Month, 3 Months, 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urogynecological Complaints measured using the Pelvic Floor Distress Inventory. | Pelvic Floor Distress Inventory - The PFDI-20 is both a symptom inventory and a measure of the degree of bother and distress (quality-of-life) caused by pelvic floor symptoms. | 1 Month, 3 Months, 6 Months |
| Change in Severity of Lumbopelvic and/or Abdominal Pain measured by Visual Analog Scale. |
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Inclusion Criteria:
Exclusion Criteria:
Postpartum women
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| Name | Affiliation | Role |
|---|---|---|
| Henri Ramirez, MD | Southern Oklahoma Women's Health 731 12th Ave NW Suite 201 Ardmore, OK 73401 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Oklahoma Women's Health | Ardmore | Oklahoma | 73401 | United States | ||
| Advanced Women's Care of the Lowcountry, PC |
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Pain will be assessed based on the Numerical Scale Response (NSR). |
| 1 Month, 3 Months, 6 Months |
| Investigator satisfaction | Satisfaction assessment will be performed by the study investigator using using 0 - 4 -points Likert scale | 1 Month, 3 Months, 6 Months |
| Subject improvement and satisfaction | Improvement and satisfaction assessment will be performed independently by the subject using 0 - 4 -points Likert scale | 1 Month, 3 Months, 6 Months |
| Bluffton |
| South Carolina |
| 29910 |
| United States |