Pelvic Floor Stimulation
DESCRIPTION
Pelvic floor stimulation (PFS) is a method of nonsurgical treatment for fecal and/or stress incontinence. Pelvic floor stimulation involves the electrical stimulation of pelvic floor muscles. More recently, electromagnetic PFS (i.e., extracorporeal pulsed magnetic innervation) has been proposed as a treatment of fecal and urinary incontinence.
Electrical PFS involves the use of a probe that is wired to a device that controls electrical impulses. This probe stimulates the pudendal nerve to improve urethral closure by activation of the pelvic floor musculature. The process is thought to improve partially denervated urethral and pelvic floor musculature by enhancing the process of reinnervation. The methods of electrical PFS have varied in location (e.g., vaginal, rectal), stimulus frequency, stimulus intensity (i.e., 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. Variation in amplitude and frequency of the electrical pulse is used to mimic and stimulate the different physiologic mechanisms of the voiding response depending on the type of etiology of incontinence (i.e., either detrusor instability, stress incontinence, or a mixed pattern) or defecation response.
Electromagnetic PFS does not require an internal electrode. This technology produces highly focused pulsed magnetic fields. During treatment, the individual sits fully clothed in a specially designed chair that has the technology embedded in the seat. This allows the therapeutic fields to be easily aimed at the muscles of the pelvic floor that control continence. The pelvic floor muscles contract and relax with each magnetic pulse. This acts as an automatic Kegel exercise machine. A treatment session takes less than 30 minutes and is typically done twice a week for six to eight weeks.
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. Electromagnetic PFS is typically delivered in the physician's office.
NeoControl® Pelvic Floor Therapy System is a type of electromagnetic PFS device.
POLICY
Pelvic floor stimulation via electrical or electromagnetic stimulation for the treatment of urinary and fecal incontinence is considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Well-designed, randomized, controlled trials with long-term follow-up are not available to determine long-term benefits of pelvic floor stimulation for the treatment of urinary and fecal incontinence compared to alternative treatments.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2011). Pelvic floor stimulation as a treatment of urinary incontinence (1.01.17). Retrieved June 9, 2011 from BlueWeb. (20 articles and/or guidelines reviewed)
Castro, R. A., Arruga, R. M., Zanetti, M. R., Santos, P. D., Sartori, M. G. & Girao, M. J. (2008). Single-blind, randomized, controlled trial of pelvic floor muscle training, electrical stimulation, vaginal cones, and no active treatment in the management of stress urinary incontinence. Clinics, 63 (4), 465-472. (Level 3 Evidence – Independent study)
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, April). Non-implantable pelvic floor electrical stimulator (NCD 230.8, p. 2-191). Ingenix.
ECRI Institute. Health Technology Information Service. Evidence Reports. (2002, April). Magnetic muscle stimulation for the treatment of urinary incontinence. Retrieved June 9, 2011 from ECRI Institute. (30 articles and/or guidelines reviewed)
Goode, P. S., Burgio, K. L., Johnson, T. M., Clay, O. J., Roth, D. L., MArkland, A. D., et al. (2011). Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: A randomized controlled trial. JAMA, 305 (2), 151-159. (Level 1 Evidence - Industry sponsored)
Imamura, M., Abrams, P., Bain, C., Buckley, B., Cardozo, L., Cody, J., et al. (2010). Systematic review and economic modelling of the effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence. Health Technology Assessment, 40 (1), 1-188.
Mariotti, G., Sciarra, A., Gentilucci, A., Salciccia, S., Alfarone, A., Di Pierro, G., et al. (2009). Early recovery of urinary continence after radical prostatectomy using early pelvic floor electrical stimulation and biofeedback associated treatment. The Journal of Urology, 181 (4), 1788-1793. (Level 3 Evidence - Independent study)
National Guideline Clearinghouse. (2010, April). Incontinence in women. In: Guidelines on urinary incontinence. Retrieved June 9, 2011 from http://www.guidelines.gov.
National Institute for Health and Clinical Excellence (NICE). (2006, October). Urinary incontinence: The management of urinary incontinence in women. Retrieved June 26, 2009 from http://www.nice.org.uk/nicemedia/live/10996/30281/30281.pdf.
National Institutes of Health. (2007, December). NIH State-of-the-Science conference statement on prevention of fecal and urinary incontinence in adults. Retrieved September 9, 2009 from http://consensus.nih.gov/2007/incontinencestatement.pdf.
Shamliyan, T. A., Wyman, J. F., Ping, R., Wilt, T. J., & Kane, R. L. (2009). Male urinary incontinence: Prevalence, risk factors, and preventive interventions. Reviews in Urology, 11 (3), 145-165.
Shamliyan, T.A., Kane, R.L., Wyman, J. & Wilt, T.J. (2008). Systematic review: randomized, controlled trials of nonsurgical treatments for urinary incontinence in women. Annuals of Internal Medicine, 148 (6), 459-474.
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/cdrh_docs/pdf8/K083704.pdf.
Winifred S. Hayes, Inc. Medical Technology Directory. (2006, March). Pelvic floor electrical stimulation for the treatment of urinary incontinence. Retrieved June 9, 2011 from www.Hayesinc.com/subscribers. (64 articles and/or guidelines reviewed)
Yamanishi, T., Mizuno, T., Watanabe, M., Honda, M., & Yoshida, K. (2007). Randomized, placebo controlled study of electrical stimulation with pelvic floor muscle training for severe urinary incontinence after radical prostatectomy. The Journal of Urology, 184 (5), 2007-2012. (Level 1 Evidence - Independent study)
ORIGINAL EFFECTIVE DATE: 12/1998
MOST RECENT REVIEW DATE: 7/14/2011
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.