Name of Section - Pelvic Floor Stimulation as a Treatment of Urinary Incontinence

IMPORTANT REMINDER

Regence Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with contract terms. Benefit determinations are based in all cases on the applicable contract language. To the extent there may be any conflict between the Medical Policy and contract language, the contract language takes precedence.

PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

Description

A variety of non-surgical approaches have been investigated as treatments of urinary incontinence, including pelvic floor muscle exercises (PME), biofeedback, other behavioral therapies, and pelvic floor stimulation. Pelvic floor stimulation (PFS) involves the electrical stimulation of pelvic floor muscles using either a probe wired to a device for controlling the electrical stimulation, or more recently, extracorporeal pulsed magnetic innervation. It is thought that pelvic floor stimulation of the pudendal nerve will improve urethral closure by activating the pelvic floor musculature. In addition, PFS is thought to improve partially denervated urethral and pelvic floor musculature by enhancing the process of reinnervation. The methods of PFS have varied in location (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. 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 type of etiology of incontinence, e.g., either detrusor instability, stress incontinence, or a mixed pattern. Magnetic pelvic floor stimulation does not require an internal electrode; patients may sit, fully clothed, on a specialized chair.

Patients receiving PFS may undergo treatments 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 is delivered in the physician's office.

Note: Stimulation of the sacral nerve as a treatment of incontinence is discussed separately in Surgery, Policy No. 134.

Policy/Criteria

Electrical or magnetic stimulation of the pelvic floor muscles (pelvic floor stimulation) as a treatment for urinary incontinence is considered investigational.

Scientific Background

Electrical Pelvic Floor Stimulation

The policy regarding electrical pelvic floor stimulation is based on a 2000 BlueCross BlueShield Association Technology Evaluation Center (TEC) assessment that reviewed the published peer-reviewed literature focusing on the safety and effectiveness of electrical pelvic floor stimulation compared to placebo and compared to other forms of behavioral therapies, including pelvic floor muscle exercises and the use of vaginal cones. (2) The specific etiologies of stress incontinence, urge incontinence, and post-prostatectomy incontinence were considered. The assessment offered the following conclusions:

1. Eleven controlled trials, of which all but one were randomized, reported outcomes of pelvic floor stimulation in the treatment of stress incontinence. These trials do not provide strong and consistent evidence that pelvic floor stimulation reduces the frequency and severity of incontinent episodes.
2. Two randomized controlled trials investigated pelvic floor stimulation in women with urge or mixed incontinence. No conclusions can be drawn from either trial. One 1997 trial did not report the key clinical outcomes, i.e., improvement and cure as measured by voiding diaries or pad testing. The second trial found no significant difference between pelvic floor stimulation and the sham treatment arm.
3. One randomized trial focused on pelvic floor stimulation for men with persistent post-prostatectomy incontinence. There was no significant difference in results between the patients receiving pelvic floor stimulation plus pelvic muscle exercises compared to those undergoing muscle exercises alone.

Since publication of the TEC Assessment, several additional published studies investigated the use of electrical pelvic floor stimulation in patients with stress incontinence, but none provided evidence supporting a beneficial effect for this diagnosis. Specifically, one small, randomized double-blind study of 27 patients compared a new pattern of electrical stimulation with sham stimulation. (3) The electrical stimulation group showed statistically greater improvement on the quality of life measure, but no between-group differences were observed in other outcome parameters, including pad testing. A second randomized trial of 60 women compared the effectiveness of electrical stimulation plus biofeedback with pelvic floor exercise. (4) The electrical stimulation-biofeedback group performed better than the pelvic floor exercise group. However, the paper did not report key clinical outcomes, e.g., improvement and cure as measured by voiding diaries or pad testing. More importantly, due to the combined therapy of electrical stimulation and biofeedback, the independent effect of electrical stimulation was not evaluated. In another randomized trial, Goode and colleagues reported the outcomes of a trial that randomized 200 women with primary stress incontinence to undergo either 8 weeks of behavioral training, 8 weeks of behavioral training plus home pelvic floor stimulation, or self-administered behavioral training alone using a self-help booklet. (5) The main outcomes measurements were the results of bladder diaries and changes in quality of life. Patients in all 3 groups reported significant improvements in incontinence; there were no significant differences between the groups.

One double-blind randomized controlled study compared the effects of electrical stimulation with sham treatment in 68 patients with urge incontinence due to detrusor overactivity. (6) Reported outcomes suggested a beneficial treatment effect with electrical stimulation. Based on patient diaries, 19% of patients receiving active treatment versus 3% of patients receiving sham treatment were cured, while 81% of active patients versus 32% of sham patients were improved. These differences were statistically significant. The study did not report the more objective pad testing, and given the inconclusive or conflicting results reported in two earlier studies, additional evidence is needed from well-designed trials to determine the benefits of electrical stimulation for urge incontinence. Wang and colleagues compared the outcomes of a 12-week program of pelvic floor muscle training, biofeedback-assisted pelvic floor muscle training, and electrical stimulation in a randomized study of in a group of 103 women with “over active bladder,” primarily due to urge incontinence. (7) The biofeedback consisted of an intravaginal electromyogram probe, while an intravaginal electrode provided the electrical stimulation. Treatment outcomes included results of voiding diaries and quality of life measures, and urodynamic measures. The authors report that both the biofeedback and electrical stimulation groups reported an increased incidence of resolution or improvement of incontinence, but do not describe how this outcome was assessed. There were significant changes in some domains of the quality of life questionnaires in the biofeedback and electrical stimulation group, and the improvement in overall quality of life score was significantly better for the electrical stimulation compared to the pelvic floor exercise group. There were no significant differences in the voiding diary scores, but the authors rejected this outcome due to missing data in the diaries. Biofeedback was associated with the greatest improvement in muscle strengthening, but as noted above, muscle strength is not considered a key clinical outcome. Pad testing, the most objective outcome was not performed.

Spruijt and colleagues reported results from a randomized trial involving women over age 65 with symptoms of stress, urge or mixed urinary incontinence. (8)  There were no statistically significant differences between patients treated with electrical stimulation versus those treated with Kegel training only. In two separate double-blind studies, symptoms were significantly reduced in both groups following treatment. (9,21) There were no significant between-group differences in outcomes.

Wille and colleagues randomized  post-prostatectomy patients to receive 1 of 3 treatments: pelvic muscle exercises (PMEs), PMEs plus electrical stimulation, or PMEs in conjunction with both electrical stimulation and biofeedback.  (10) Outcomes were evaluated according to questionnaires and the more objective pad test.  There were no statistically significant differences in continence rates between the three groups.

Magnetic Pelvic Floor Stimulation

A 2000 TEC Assessment evaluated the use of electromagnetic pelvic floor stimulation.  (11) At the time, minimal data regarding these devices were available, and no randomized trials had isolated and validated the effectiveness of the treatment.  (12,13) Galloway and colleagues presented the results of a multicenter prospective nonrandomized trial in 83 patients with stress urinary incontinence.  (14) Patients were treated for 20 minutes twice a week for six weeks. A total of 66% of patients were either dry or using no more than one pad per day after a 3-month follow-up. The TEC Assessment concluded that these preliminary results require confirmation in randomized trials.

A study of 52 patients randomized to either active or sham magnetic stimulation reported statistically significant differences between baseline and post treatment measures in the active functional magnetic stimulation group. (15) However, p values were not reported for comparisons between the placebo and treatment groups. Thus, it is not possible to reach scientific conclusions from this study concerning the effects of functional magnetic stimulation on health outcomes.  Another randomized, double-blind, sham controlled study of 39 patients reported significant improvement between baseline and post treatment measures in both the active and sham groups at 24 weeks follow-up. (20) The between group comparison was not statistically significant.

In addition to the above study, Galloway and colleagues reported an update of the multicenter prospective nonrandomized trial that included 111 women with stress urinary incontinence who were treated with extracorporeal magnetic innervation. (16) A total of 47 women completed 6-month follow-up testing; 38 patients were completely dry or used less than 1 pad per day (81%). Pad use was reduced in 33 patients (70%). Nevertheless, lacking a control group, the influence of patient selection bias on these outcomes cannot be ruled out.

Fujishiro and colleagues published the results of a trial that enrolled 37 women with frequency or urge incontinence to receive either true or placebo magnetic stimulation.  (17) Outcomes were assessed at 3 days and 1 week after treatment. The authors reported the treatment group reported improvement in the urine volume, number of leaks, and quality of life. However, the short follow-up of 1 week precludes scientific conclusions.  Voorham-van der Zalm and colleagues reported no significant difference in before and after treatment outcomes in 74 patients who received eight weeks of magnetic stimulation treatment. (18)  Although several other studies have been published, including one comparative trial  (19), none included a placebo control; therefore, it is not possible to draw scientific conclusions concerning the treatment effects of magnetic stimulation on incontinence.

In summary, the evidence published to date is not sufficient to demonstrate that electrical or magnetic pelvic floor stimulation results in improved health outcomes in patients with urinary incontinence when compared to either sham devices or behavioral therapy. An updated search of the MEDLINE database through February 10, 2008 failed to return any studies of electrical or magnetic stimulation that alter the conclusions reached above.

References

1. BlueCross BlueShield Association Medical Policy Reference Manual, Policy No. 1.01.17
2. TEC Assessment: Pelvic Floor Stimulation in the Treatment of Urinary Incontinence, 2000; BlueCross and BlueShield Association Technology Evaluation Center Vol 15, Tab 2
3. Jeyaseelan SM, Haslam EJ, Winstanly J et al. An evaluation of a new pattern of electrical stimulation as a treatment for urinary stress incontinence: a randomized, double-blind, controlled trial. Clin Rehabil 2000;14(6):631-40
4. Sung MS, Hong JY, Choi YH et al. FES-biofeedback versus intensive pelvic floor muscle exercise for the prevention and treatment of genuine stress incontinence. J Korean Med Sci 2000;15(3):303-8
5. Goode PS, Burgio KL, Locher JL, et al. Effect of behavioral training with or without pelvic floor electrical stimulation on stress incontinence in women: a randomized controlled trial. JAMA 2003;290(3):345-52
6. Yamanishi T, Yasuda K, Sakakibara R et al. Randomized, double-blind study of electrical stimulation for urinary incontinence due to detrusor overactivity. Urology 2000;55(3):353-7
7. Wang AC, Wang YY, Chen MC. Single-blind, randomized trial of pelvic floor muscle training, biofeedback-assisted pelvic floor muscle training, and electrical stimulation in the management of overactive bladder. Urology 2004:63(1):61-6
8. Spruijt J, Vierhout M, Verstraeten R, Janssens J, Burger C. Vaginal electrical stimulation of the pelvic floor: a randomized feasibility study in urinary incontinent elderly women. Acta Obstet Gynecol Scand 2003;82(11):1043-8
9. Amaro JL, Gameiro MO, Padovani CR, et al. Effect of intravaginal electrical stimulation on pelvic floor muscle strength. Int Urogynecol J Pelvic Floor Dysfunct 2005;16(5):355-8
10. Wille S, Sobottka A, Heidenreich A, Hofmann R. Pelvic floor exercises, electrical stimulation and biofeedback after radical prostatectomy: results of a prospective randomized trial. J Urol 2003;170(2 Pt 1):490-3
11. TEC Assessment: Magnetic Stimulation in the Treatment of Urinary Incontinence in Adults, 2000; BlueCross and BlueShield Association Technology Evaluation Center Vol 15, Tab 8
12. Yamanishi T, Yasuda K, Suda S et al. Effect of functional continuous magnetic stimulation for urinary incontinence. J Urol 2000;163(2):456-9
13. Fujishiro T, Enomoto H, Ugawa Y et al. Magnetic stimulation of the sacral roots for the treatment of stress incontinence: an investigational study and placebo controlled trial. J Urol 2000;164(4):1277-9
14. Galloway NT, El-Gallery RE, Sand K et al. Extracorporeal magnetic innervation therapy for stress urinary incontinence. Urology 1999;53(6):1108-11
15. But I. Conservative treatment of female urinary incontinence with functional magnetic stimulation. Urology 2003;61(3):558-61
16. Galloway NT, El-Gallery RE, Sand K. Update on extracorporeal magnetic innervation (ExMI) therapy for stress urinary incontinence. Urology 2000;56(6 suppl 1):82-6
17. Fujishiro T, Takahashi S, Enomoto H et al. Magnetic stimulation of the sacral roots for the treatment of urinary frequency and urge incontinence: an investigational study and placebo controlled trial. J Urol 2002;168(3):1036-9
18. Voorham-van der Zalm PJ, Pelger RC, Stiggelbout AM, et al. Effects of magnetic stimulation in the treatment of pelvic floor dysfunction. BJU Int 2006;97(5):1035-8
19. Yokoyama T, Nishiguchi J, Watanabe T. Comparative study of effects of extracorporeal magnetic innervation versus electrical stimulation for urinary incontinence after radical prostatectomy. Urology 2004;63(2):264-7
20. Suzuki T, Yasuda K, Yamanishi T, et al. Randomized, double-blind, sham-controlled evaluation of the effect of functional continuous magnetic stimulation in patients with urgency incontinence. Neurourol Urodyn 2007;26(6):767-72
21. Amaro JL, Gamiero MO, Kawano PR, et al. Intravaginal electrical stimulation: a randomized, double-blind study on the treatment of missed urinary incontinence. Acta Obstet Gynecol Scand 2006;85(5):619-22

Cross References

Sacral Nerve Modulation/Stimulation for Pelvic Floor Dysfunction, Regence Medical Policy Manual, Surgery Policy No. 134

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