Urinary incontinence (UI) is a common condition defined as an involuntary leakage of urine. Women are twice as likely to be affected as men, and prevalence increases with age. The severity of incontinence affects quality of life and treatment decisions. The types of urinary incontinence include stress, urge, overflow, functional, and post-prostatectomy incontinence. Nonsurgical treatment options may include pharmacologic treatment, pelvic muscle exercises (PME), bladder training exercises, electrical stimulation, and neuromodulation. Biofeedback, in conjunction with PME, has been proposed as a treatment modality for stress, urge, mixed, and overflow urinary incontinence because it may enhance awareness of body functions and the learning of pelvic floor exercises. There are several proposed methods of biofeedback which may be employed for the treatment of urinary incontinence, including vaginal cones or weights, perineometers, and electromyographic (EMG) systems with vaginal and rectal sensors. Biofeedback is a technique intended to teach patients self-regulation of certain physiologic processes not normally considered to be under voluntary control. The technique involves the feedback of a variety of types of information not commonly available to the patient, followed by a concerted effort on the part of the patient to use this feedback to help alter the physiologic process in some specific way.
Biofeedback has been proposed as a treatment for a variety of diseases and disorders, including anxiety, headaches, hypertension, movement disorders, incontinence, pain, asthma, Raynaud’s disease, and insomnia. Biofeedback training is done either in individual or group sessions and as a single therapy or in combination with other therapies designed to teach relaxation. A typical program consists of 10 to 20 training sessions of 30 minutes each. Training sessions are performed in a quiet, nonarousing environment. Subjects are instructed to use mental techniques to affect the physiologic variable monitored, and feedback is provided for successful alteration of the physiologic parameter. This feedback may be in the form of signals, such as lights or tone, verbal praise, or other auditory or visual stimuli.
The various forms of biofeedback mainly differ in the nature of the disease or disorder under treatment, the biologic variable that the individual attempts to control, and the information that is fed back to the individual. Biofeedback techniques include peripheral skin temperature feedback, blood-volume-pulse feedback (vasoconstriction and dilation), vasoconstriction training (temporalis artery), and EMG biofeedback; these may be used alone or in conjunction with other therapies (e.g., relaxation, behavioral management, medication).
A variety of biofeedback devices are cleared for marketing though the U.S. Food and Drug Administration’s (FDA) 510(k) process. The FDA defines a biofeedback device as “an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters”.