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Incontrol medical electrode9/9/2023 ![]() A systematic review of RCTs on magnetic PFS for urinary incontinence in women concluded that the evidence was insufficient due to the small number of trials with short-term follow-up, methodological limitations and heterogeneity in patient populations, interventions and outcome reporting. Relevant outcomes are symptoms, quality of life and treatment-related morbidity. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.įor individuals who have urinary incontinence who receive magnetic PFS, the evidence includes RCTs and a systematic review. Systematic reviews of RCTs have not found that electrical stimulation is superior to control interventions for treating fecal incontinence. Among the RCTs that have evaluated electrical PFS as a treatment for fecal incontinence only 1 trial was sham-controlled, and it did not find that electrical stimulation improved the net health outcome. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.įor individuals who have fecal incontinence who receive electrical PFS, the evidence includes RCTs and systematic reviews. Moreover, meta-analyses of RCTs have not found a significant benefit of electrical PFS in men with postprostatectomy incontinence compared with a control intervention. Findings from systematic reviews have not found that electrical PFS used to treat urinary incontinence in women consistently improves the net health outcome compared with placebo or other conservative treatments. ![]() SUMMARY OF EVIDENCE:įor individuals who have urinary incontinence who receive electrical PFS, the evidence includes systematic reviews of RCTs. The most recent literature was reviewed through June 16, 2022. This policy is updated regularly with searches of the PubMed database. Note: Stimulation of the sacral nerve as a treatment of incontinence is discussed separately (see Medical Policy #159 Sacral Nerve Modulation/Stimulation). Magnetic PFS may be delivered in the physician’s office. Patients receiving electrical PFS may undergo treatment in a physician’s office or physical therapy facility, or patients may undergo initial training in a physician’s office followed by home treatment with a rented or purchased pelvic floor stimulator. Magnetic PFS does not require an internal electrode instead, patients sit fully clothed on a specialized chair with an embedded magnet. Variation in the amplitude and frequency of the electrical pulse is used to mimic and stimulate the different physiologic mechanisms of the voiding response, depending on the etiology of the incontinence, i.e., either detrusor instability, stress incontinence, or a mixed pattern. ![]() The methods of electrical PFS have varied in location (e.g., vaginal, rectal), stimulus frequency, stimulus intensity or amplitude, pulse duration, pulse to rest ratio, treatments per day, number of treatment days per week, length of time for each treatment session, and overall time period for device use between clinical and home settings. In addition, PFS is thought to improve partially denervated urethral and pelvic floor musculature by enhancing the process of reinnervation. Stimulation of the pudendal nerve to activate the pelvic floor musculature may lead to improved urethral closure. Pelvic floor stimulation (PFS) involves electrical stimulation of pelvic floor muscles using either a probe wired to a device for controlling the electrical stimulation or, more recently, extracorporeal electromagnetic (also called magnetic) pulses. Electrical stimulation of the pelvic floor is also proposed as a treatment of fecal incontinence. This approach involves either electrical stimulation of pelvic floor musculature or extracorporeal pulsed magnetic stimulation. Pelvic floor stimulation (PFS) is proposed as a nonsurgical treatment option for women and men with urinary incontinence. ![]() ![]() Electrical or magnetic stimulation of the pelvic floor muscles (pelvic floor stimulation) as treatment for urinary or fecal incontinence is considered investigational. ![]()
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