Pelvic Floor Stimulation
Pelvic floor stimulation (PFS) is a proposed method of nonsurgical treatment for men and women with fecal and/or urinary incontinence. Pelvic floor stimulation involves the electrical stimulation of pelvic floor muscles. More recently, extracorporeal electromagnetic (also called magnetic) pulses have been proposed as a treatment of fecal and urinary incontinence.
The methods of electrical PFS have varied in location (e.g., vaginal, rectal), stimulus frequency, intensity or amplitude, pulse duration, pulse to rest ratio, treatments per day and week, length of time per treatment, and overall time period for device use between clinical and home settings. Magnetic PFS does not require an internal electrode; instead, patients sit fully clothed on a specialized chair with an embedded magnet. 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. Examples of these devices include, but are not limited to, MyoTrac Infiniti™, a non-implanted electrical stimulator, the Pathway™ CTS 2000, and the InCare® PRS.
Pelvic floor stimulation via electrical stimulation for the treatment of urinary and fecal incontinence is considered investigational.
Pelvic floor stimulation via electromagnetic stimulation for the treatment of urinary and fecal incontinence is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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Well-designed, randomized, controlled trials with long-term follow-up are necessary to determine long-term benefits of pelvic floor stimulation for the treatment of urinary and fecal incontinence compared to alternative treatments.
Agency for Healthcare Research and Quality (AHRQ). (August 2009). Evidence Report. Treatment of overactive bladder in women. Evidence report number 187. Retrieved October 13, 2016 from http://www.ahrq.gov/research/findings/evidence-based-reports/er187-abstract.html.
American Urological Association, Society of Urodynamics, Female Pelvic Medicine. (2014). Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. Retrieved August 7, 2017 from the National Guideline Clearinghouse (NGC: 010422).
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2016). Pelvic floor stimulation as a treatment of urinary and fecal incontinence (1.01.17). Retrieved August 7, 2017 from BlueWeb. (28 articles and/or guidelines reviewed)
Cao, Y., Lv, J., Zhao,C., Li, J., & Leng, J. (2016). Cholinergic antagonists combined with electrical stimulation or bladder training treatments for overactive bladder in female adults: a meta-analysis of randomized controlled trials. Clinical Drug Investigation, 36 (10), 801-808. Abstract retrieved August 7, 2017 from PubMed database.
Center for Medicare and Medicaid Services. CMS.gov. NCD forNon-implantable pelvic floor electrical stimulator (230.8). Retrieved October 12, 2016 from https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=231.
Lim, R., Lee, S., Tan, P., Liong, M., & Yuen, K. (2015). Efficacy of electromagnetic therapy for urinary incontinence: a systematic review. Neurourology and Urodynamics, 34 (8), 713-722. Abstract retrieved August 7, 2017 from PubMed database.
National Institute for Health and Clinical Excellence (NICE). (2007). Faecal incontinence in adults: management. Retrieved August 7, 2014 from www.nice.org.uk/guidance/cg49.
National Institute for Health and Clinical Excellence (NICE). (2015). Urinary incontinence in women: management. Retrieved October 12, 2016 from www.nice.org.uk/guidance/cg171.
Schreiner, L., Santos, T., Souza, A., Nygaard, C., Silva, I. (2013). Electrical stimulation for urinary incontinence in women: a systematic review. International Braz J Urol, 39 (4), 454-464. Abstract retrieved August 7, 2017 from PubMed database.
U. S. Food and Drug Administration. (1998, June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K973096. Retrieved November 17, 2015 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2006, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K053434. Retrieved November 17, 2015 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2009, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K083704. Retrieved June 9, 2011 from http://www.accessdata.fda.gov.
Vonthein, R., Heimerl, T., Schwander, T., & Ziegler, A. (2013). Electrical stimulation and biofeedback for the treatment of fecal incontinence: a systematic review. International Journal of Colorectal Disease, 28 (11), 1567-1577. (Level 1 evidence)
Wang, S., Lv, J., Feng, X., Wang, G., & Lv, T. (2016). Efficacy of electrical pudendal nerve stimulation in treating female stress incontinence. Urology, 91, 64-69. Abstract retrieved October 13, 2016 from PubMed database.
Winifred S. Hayes, Inc. Medical Technology Directory. (2006, March; last update search February 2017). Pelvic floor electrical stimulation for the treatment of urinary incontinence. Retrieved August 7, 2017 from www.Hayesinc.com/subscribers. (98 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 12/1998
MOST RECENT REVIEW DATE: 9/14/2017
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