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Pelvic floor stimulation is a nonsurgical treatment for individuals with urinary incontinence. These devices stimulate the pudendal nerve to activate pelvic floor muscles. Pelvic floor electrical stimulation (PFES) is a type of transcutaneous electrical nerve stimulation (TENS) that uses a probe wired to a device that controls the level of stimulation. Magnetic (also called electromagnetic) stimulation delivers pulses using a specialized chair with an embedded magnet.
Several non-implanted PFES devices have been cleared by the U.S. Food and Drug Administration (FDA) to treat urinary incontinence. These include but are not limited to the EmbaGYN®, itouch Sure Pelvic Floor Exerciser, Attain and UROstim™ devices. An extracorporeal pelvic floor magnetic stimulation device, the NeoControl® Pelvic Floor Therapy System was approved by the FDA for treatment of male and female urinary and fecal incontinence.
I. Pelvic Floor Electrical Stimulation
Use of non-implanted pelvic floor electrical stimulation may be considered MEDICALLY NECESSARY AND APPROPRIATE for treatment of non-neurogenic or urge urinary incontinence in patients who have undergone a trial of pelvic muscle exercises for a period of at least four (4) weeks with no significant improvement in incontinence.
II. The following non-implanted pelvic floor stimulation treatments for urinary incontinence are considered EXPERIMENTAL/INVESTIGATIVE due to lack of clinical evidence demonstrating an impact on improved health outcomes:
No additional statements.
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