Clinical Evaluation of Fractional Bi-Polar RF for Symptoms of SUI and Vulvovaginal Atrophy

Exclusion Criteria

• •\- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
• •Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance, unless deep enough in the periostal plane.
• •Current or history of cancer, or premalignant condition in the treatment area.
• •Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
• •Pregnancy and nursing.
• •Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
• •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.
• •Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction.
• •Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
• •History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
• •History of bleeding coagulopathies or use of anticoagulants in the last 10 days.
• •Any surgery in treated area within 3 months prior to treatment.
• •Simultaneous participation in another investigator drug or device study or completion of the follow-up phase for the primary endpoint of any previous study less than 30 days prior to the first evaluation in this study.
• •Six months delay is required if other recent treatments like light, CO2 laser or RF were performed on the same area.
• •Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
• •As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient