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.
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
Berghmans, L. C., Hendriks, H. J., De Bie, R. A., Van Waalwijk Van Doorn, E. S., Bo, K., & Van Kerrebroeck, E. V. (2000). Conservative treatment of stress urinary incontinence in women: A systematic review of randomized clinical trials. British Journal of Urology, 85 (3), 254-263.
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2009). Pelvic floor stimulation as a treatment of urinary incontinence (1.01.17). Retrieved August 24, 2009 from BlueWeb. (24 articles and/or guidelines reviewed)
Bo, K., Talseth, T., & Holme, I. (1999). Single blind randomized controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women. British Medical Journal, 318 (7182), 487-493.
Castro, R.A., Arruga, R.M., Janette, M.R., Santos, P.D., Sartorii, M.G. & Giro, 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 of Evidence 3)
Complete Guide to Medicare Coverage Issues [Computer software]. (2009, July). Non-implantable pelvic floor electrical stimulator (NCD 230.8, p. 2-187). The Ingenix Complete Guide to Medicare Coverage Issues.
ECRI Institute. Health Technology Information Service. Evidence Reports (2002, April). Magnetic muscle stimulation for the treatment of urinary incontinence. Retrieved October 3, 2005 from ECRI Institute. (30 articles and/or guidelines reviewed)
Gallo, M., & Sasso, K. C. (1997). Key components of patient education for pelvic floor stimulation in the treatment of urinary incontinence. Urologic Nursing, 17 (1), 10-16.
Hayes. Medical Technology Directory. (2006, March). Pelvic floor electrical stimulation for the treatment of urinary incontinence. Retrieved August 24, 2009 from www.Hayesinc.com/subscribers. (64 articles and/or guidelines reviewed)
National Guidelines Clearance. (2006). Urinary incontinence: the management of urinary incontinence in women. Retrieved September 9, 2009 from http://www.guideline.gov/summary/summary.aspx?doc_id=9926&nbr=005321&string=pelvic+AND+floor+AND+stimulation.
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/2007/2007IncontinenceSOS030Statementpdf.pdf.
Odagaki, M., Suga, K., Sasaki, T., & Hosaka, H. (2004). Study on optimization for current distribution in magnetic stimulation therapy for urinary incontinence. Neurology and Clinical Neurophysiology, 2004 (44), 1-5.
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.
ORIGINAL EFFECTIVE DATE: 12/1998
MOST RECENT REVIEW DATE: 11/12/2009
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.