Pelvic Floor Stimulation
DESCRIPTION
Pelvic floor stimulation (PFS) is a proposed method of nonsurgical treatment for fecal and/or urinary incontinence. This approach involves either electrical stimulation of pelvic floor musculature or extracorporeal pulsed magnetic 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. Stimulation of the pudendal nerve to activate the pelvic floor musculature is proposed to improve urethral closure. In addition, PFS is thought to improve partially denervated urethral and pelvic floor musculature by enhancing the process of reinnervation. 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. Variations in the amplitude and frequency of the electrical pulse are 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). Individuals receiving electrical PFS may undergo treatment in a physician's office or physical therapy facility, or they 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 MyoTrac Infiniti™, a non-implanted electrical stimulator, the Pathway™ CTS 2000, ApexM, NeoControl®, and the InCare® PRS.
Magnetic PFS does not require an internal electrode; instead, patients sit fully clothed on a specialized chair with an embedded magnet. Magnetic PFS may be administered in the physician's office.
POLICY
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.
IMPORTANT REMINDERS
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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ADDITIONAL INFORMATION
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.
SOURCES
Abdelbary, A.M., El-Dessoukey, A.A., Massoud, A.M., Moussa, A., Zayed, A., Elsheikh, M., et al. (2015). Combined vaginal pelvic floor electrical stimulation (PFS) and local vaginal estrogen for treatment of overactive bladder (OAB) in perimenopausal females. Randomized controlled trial (RCT). Urology, 86 (3), 482-486. Abstract retrieved April 30, 2020 from PubMed database.
American College of Gastroenterology. (2021, October). ACG clinical guidelines: management of benign anorectal disorders. Retrieved March 31, 2023 from http://www.gi.org/guidelines/.
American Urological Association, Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction. (2019; 2019 Amendment). Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. Retrieved March 30, 2023 from http://www.auanet.org/guidelines.
American Urological Association, Society of Urodynamics. (2019, August). Incontinence after prostate treatment: AUA/SUFU guideline. Retrieved March 31, 2023 from http://www.auanet.org/guidelines.
BlueCross BlueShield Association. Evidence Positioning System. (9:2022). Pelvic floor stimulation as a treatment of urinary and fecal incontinence (1.01.17). Retrieved March 30, 2023 from https://www.bcbsaoca.com/eps/ (31 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.
Li, W., Hu, Q., Zhang, Z., Shen, F., & Xie, Z. (2020). Effect of different electrical stimulation protocols for pelvic floor rehabilitation of postpartum women with extremely weak muscle strength: Randomized control trial. Medicine, 99 (17), e19863. (Level 3 evidence)
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). (2019, April). Urinary incontinence in women: management. Retrieved June 4, 2019 from www.nice.org.uk/guidance/cg171.
Sciarra, A., Viscuso, P., Arditi, A., Mariotti, G., De Berardinis, E., Di Pierro, G., et al. (2021). A biofeedback-guided programme or pelvic floor muscle electric stimulation can improve early recovery of urinary continence after radical prostatectomy: A meta-analysis and systematic review. International Journal of Clinical Practice, 75 (10), e14208, doi: 10.1111/ijcp.14208. Abstract retrieved March 31, 2023 from PubMed database.
Simillis, C., Lal, N., Pellino, G., Baird, D., Nikolaou, S., Kontovounisios, C., et al. (2019). A systematic review and network meta-analysis comparing treatments for faecal incontinence. International Journey of Surgery, 66, 37-47. (Level 1 evidence)
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.
Xiao-xing, M., & An Liu, M.B. (2019). Effectiveness of electrical stimulation combined with pelvic floor muscle training on postpartum urinary incontinence. Medicine (Baltimore), 98 (10), e14762. (Level 1 evidence)
ORIGINAL EFFECTIVE DATE: 12/1998
MOST RECENT REVIEW DATE: 5/11/2023
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