Clinical trial NCT03917160: Evaluate the Effect of Abdominal Electrical Muscle Stimulation on Abdominal Wall Restoration in Post - Partum Women
Official title: A Randomized Controlled Trial to Evaluate the Effect of Abdominal EMS (Electrical Muscle Stimulation) on AWR (Abdominal Wall Restoration) in Post - Partum Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Wall Restoration
Diastasis Recti
Lead sponsor: InMode MD Ltd.
Sponsor class: INDUSTRY
First posted: 2019-04-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* - Post-partum women aged 18-45 years with symptoms of diastasis recti and weakness of the linea alba
* Informed Consent Form signed by the subject.
* BMI interval: 18.5 ≤ BMI ≤ 32 (normal to overweight, but not obese).
* Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
* Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.
* In addition, negative urine pregnancy test as tested before each treatment and at the last visit for women with childbearing potential (e.g. not menopause).

Exclusion Criteria:

* - Unable to commit to future appointments
* Planning on moving away from the local area within 6 months
* History of other energy-based therapy within one year
* Diffuse pain syndrome or chronic pain requiring daily narcotics
* Active electrical implant/device in any region of the body, including pacemaker or internal defibrillator
* Permanent implant in the treated area such as metal plates, screws or silicon, metal piercing or other.
* Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles.
* Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
* History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
* History of bleeding coagulopathies or use of anticoagulants except for low-dose aspirin.
* Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
* Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
* Pregnancy.
* Poorly controlled endocrine disorders, such as Diabetes, or thyroid dysfunction and hormonal virilization.
* Isotretinoin (Accutane) within last 6 months.
* Any active condition in the treatment area, such as sores, Psoriasis, eczema, and rash, open lacerations, abrasions or lesions, infection in the area to be treated, current urinary tract infection or pelvic infection, uterine prolapse, cystocele, rectocele.
* Any surgical procedure in the treatment area within the last 12 months or before complete healing.
* Having received treatment with light, laser, RF, or other devices in the treated area within 2-3 weeks for non-ablative procedures, and 6-12 weeks for ablative fractional laser resurfacing (according to treatment severity) prior to treatment, except special recommendations.
* Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session, as per the practitioner's discretion.
* As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.
* Any therapies or medications which may interfere with the use of the study device.
* Compromised health as determined by the study doctor.

Primary outcomes:
measure: Change in inter-recti distance (IRD), measured via Magnetic Resonance Imaging.
timeFrame: 1 month
measure: Change in inter-recti distance (IRD), measured via UltraSound Imaging to evaluate effect of the treatment
timeFrame: 1 Month, 3 Months, 6 Months
Secondary outcomes:
measure: Change in Urogynecological Complaints measured using the Pelvic Floor Distress Inventory.
timeFrame: 1 Month, 3 Months, 6 Months
measure: Change in Severity of Lumbopelvic and/or Abdominal Pain measured by Visual Analog Scale.
timeFrame: 1 Month, 3 Months, 6 Months
measure: Investigator satisfaction
timeFrame: 1 Month, 3 Months, 6 Months
measure: Subject improvement and satisfaction
timeFrame: 1 Month, 3 Months, 6 Months
Other outcomes:
Locations:
city: Ardmore
country: United States
facility: Southern Oklahoma Women's Health
state: Oklahoma
city: Bluffton
country: United States
facility: Advanced Women's Care of the Lowcountry, PC
state: South Carolina
Study officials:
affiliation: Southern Oklahoma Women's Health 731 12th Ave NW Suite 201 Ardmore, OK 73401
name: Henri Ramirez, MD
role: PRINCIPAL_INVESTIGATOR
References: