Medical policy: Pelvic Floor Stimulation as a Treatment of Urinary and Fecal Incontinence

Número de política: MP 6.024

Fecha de entrada en vigor: 11/1/2026

Política

Electrical or magnetic stimulation of the pelvic floor muscles (pelvic floor stimulation) as a treatment for urinary incontinence is considered investigational. No hay pruebas suficientes para apoyar una conclusión general con respecto a los resultados o beneficios para la salud asociados con este procedimiento.

Electrical or magnetic stimulation of the pelvic floor muscles (pelvic floor stimulation) as a treatment for fecal incontinence is considered investigational. No hay pruebas suficientes para apoyar una conclusión general con respecto a los resultados o beneficios para la salud asociados con este procedimiento.

Referencias cruzadas

• MP 1.033 Sacral Nerve Neuromodulation/Stimulation
• MP 1.134 Tibial Nerve Stimulation
• MP 2.398 Biofeedback as a Treatment of Fecal Incontinence or Constipation
• MP 2.399 Biofeedback as a Treatment of Urinary Incontinence in Adults

Variaciones del producto

Esta política solo se aplica a ciertos programas y productos administrados por Capital Blue Cross y está sujeta a variaciones en los beneficios. Consulte la información adicional a continuación.

FEP PPO - Refer to Section VI of the FEP Medical Policy Manual. The FEP Medical Policy Manual can be found at: FEP Medical Policy Manual.

Descripción/Antecedentes

Pelvic floor stimulation

Pelvic floor 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 may 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). 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. Magnetic PFS may be administered in the physician's office.

Situación reglamentaria

Several electrical stimulators have been cleared by the U.S. Food and Drug Administration (FDA) through the 510(k) process, such as nonimplanted electrical stimulators for treating urinary incontinence and predicate devices which are also used to treat urinary incontinence.

FDA product code: KPI.

Fundamento

For individuals who have urinary incontinence who receive electrical pelvic floor stimulation (PFS), the evidence includes systematic reviews. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. Findings from systematic reviews have not found that electrical PFS used to treat urinary incontinence in women consistently improves the net health outcome compared with placebo or other conservative treatments. Moreover, meta-analyses of RCTs have not found a significant benefit of electrical PFS in men with postprostatectomy incontinence compared with a control intervention. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

For individuals who have fecal incontinence who receive electrical PFS, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. Among the RCTs that have evaluated electrical PFS as a treatment for fecal incontinence, only 1 trial was sham-controlled, and it did not find that electrical stimulation improved the net health outcome. Systematic reviews of RCTs have not found that electrical stimulation is superior to control interventions for treating fecal incontinence. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

For individuals who have urinary incontinence who receive magnetic PFS, the evidence includes systematic reviews and RCTs. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. A systematic review of RCTs on magnetic PFS for urinary incontinence in women concluded that the evidence was insufficient due to the following factors: a low number of trials with short-term follow-up, methodologic limitations, as well as heterogeneity in patient populations, interventions, and outcomes reported. One RCT evaluating magnetic stimulation for treating men with postprostatectomy urinary incontinence reported short-term results favoring magnetic PFS; however, the trial was small and lacked a sham comparator. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

For individuals who have fecal incontinence who receive magnetic PFS, no relevant evidence was identified. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Definiciones

N/D

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen un consejo médico y están sujetas a cambios según lo permita la ley o la evidencia clínica aplicable de las pautas de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas políticas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. El procesamiento final de una reclamación se basa en los términos del contrato que se aplican al programa de beneficios de los miembros, incluidas las limitaciones y exclusiones de beneficios. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Información de codificación

Nota: esta lista de códigos puede no ser exhaustiva y los códigos están sujetos a cambios en cualquier momento. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

Pelvic floor stimulation for the treatment of urinary or fecal incontinence is considered investigational; therefore, not covered

Referencias

1. Gorina Y, Schappert S, Bercovitz A, et al. Prevalence of incontinence among older americans. Vital Health Stat 3. Jun 2014; (36): 1-33. PMID 24964267
2. Markland AD, Goode PS, Redden DT, et al. Prevalence of urinary incontinence in men: results from the national health and nutrition examination survey. J Urol. Septiembre de 2010; 184(3): 1022-7. PMID 20643440
3. Abdelbary AM, El-Dessoukey AA, Massoud AM, et al. 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. Sep 2015; 86(3): 482-6. PMID 26135813
4. Naidu D, Modi R, Kulkarni M, et al. Intravaginal electrical stimulation of the pelvic floor for women with urinary incontinence - a systematic review of randomised controlled trials. Am J Obstet Gynecol. Mar 20 2025. PMID 40120731
5. Leonardo K, Seno DH, Mirza H, et al. Biofeedback-assisted pelvic floor muscle training and pelvic electrical stimulation in women with overactive bladder: A systematic review and meta-analysis of randomized controlled trials. Neurourol Urodyn. Aug 2022; 41(6): 1258-1269. PMID 35686543
6. Stewart F, Berghmans B, Bø K, et al. Electrical stimulation with non-implanted devices for stress urinary incontinence in women. Cochrane Database Syst Rev. Dec 22 2017; 12(12): CD012390. PMID 29271482
7. Shamliyan T, Wyman J, Kane R. Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness (Comparative Effectiveness Review 36). Rockville, MD: Agency for Healthcare Research and Quality; 2012.
8. Moroni RM, Magnani PS, Haddad JM, et al. Conservative Treatment of Stress Urinary Incontinence: A Systematic Review with Meta-analysis of Randomized Controlled Trials. Rev Bras Ginecol Obstet. Febrero de 2016; 38(2): 97-111. PMID 26883864
9. Tang G, Liu M, Chen X, et al. Effectiveness of electrical stimulation for treating male urinary incontinence after prostatectomy: a meta-analysis and systematic review. Int J Surg. Jun 27 2025. PMID 40576184
10. Sciarra A, Viscuso P, Arditi A, et al. 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. Int J Clin Pract. Oct 2021; 75(10): e14208. PMID 33811418
11. Berghmans B, Hendriks E, Bernards A, et al. Electrical stimulation with non-implanted electrodes for urinary incontinence in men. Cochrane Database Syst Rev. Jun 06 2013; 2013(6): CD001202. PMID 23740763
12. Johnson EE, Mamoulakis C, Stoniute A, et al. Conservative interventions for managing urinary incontinence after prostate surgery. Cochrane Database Syst Rev. Apr 18 2023; 4(4): CD014799. PMID 37070660
13. Zhu YP, Yao XD, Zhang SL, et al. Pelvic floor electrical stimulation for postprostatectomy urinary incontinence: a meta-analysis. Urology. Mar 2012; 79(3): 552-5. PMID 22386394
14. Cohen-Zubary N, Gingold-Belfer R, Lambort I, et al. Home electrical stimulation for women with fecal incontinence: a preliminary randomized controlled trial. Int J Colorectal Dis. Apr 2015; 30(4): 521-8. PMID 25619464
15. Norton C, Gibbs A, Kamm MA. Randomized, controlled trial of anal electrical stimulation for fecal incontinence. Dis Colon Rectum. Feb 2006; 49(2): 190-6. PMID 16362803
16. Vonthein R, Heimerl T, Schwandner T, et al. Electrical stimulation and biofeedback for the treatment of fecal incontinence: a systematic review. Int J Colorectal Dis. Nov 2013; 28(11): 1567-77. PMID 23900652
17. Schwandner T, König IR, Heimerl T, et al. Triple target treatment (3T) is more effective than biofeedback alone for anal incontinence: the 3T-AI study. Dis Colon Rectum. Jul 2010; 53(7): 1007-16. PMID 20551752
18. Schwandner T, Hemmelmann C, Heimerl T, et al. Triple-target treatment versus low-frequency electrostimulation for anal incontinence: a randomized, controlled trial. Dtsch Arztebl Int. Sep 2011; 108(39): 653-60. PMID 22013492
19. Hosker G, Cody JD, Norton CC. Electrical stimulation for faecal incontinence in adults. Cochrane Database Syst Rev. Jul 18 2007; 2007(3): CD001310. PMID 17636665
20. Lim R, Lee SW, Tan PY, et al. Efficacy of electromagnetic therapy for urinary incontinence: A systematic review. Neurourol Urodyn. Nov 2015; 34(8): 713-22. PMID 25251335
21. Lim R, Liong ML, Leong WS, et al. Pulsed Magnetic Stimulation for Stress Urinary Incontinence: 1-Year Followup Results. J Urol. Mayo de 2017; 197(5): 1302-1308. PMID 27871927
22. Unal B, Sarsan A, Yıldız N, et al. Efficacy of Magnetic Stimulation in Men With Urinary Incontinence After Radical Prostatectomy: A Randomized, Quadruple-Blind, Sham-Controlled Clinical Trial. Neurourol Urodyn. Junio de 2025; 44(5): 1140-1148. PMID 40223765
23. Wald A, Bharucha AE, Limketkai B, et al. ACG Clinical Guidelines: Management of Benign Anorectal Disorders. Am J Gastroenterol. Oct 01 2021; 116(10): 1987-2008. PMID 34618700
24. Bordeianou LG, Thorsen AJ, Keller DS, et al. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Fecal Incontinence. Dis Colon Rectum. May 01 2023; 66(5): 647-661. PMID 40324433
25. Cameron AP, Chung DE, Dielubanza EJ, et al. The AUA/SUFU Guideline on the Diagnosis and Treatment of Idiopathic Overactive Bladder. J Urol. Jul 2024; 212(1): 11-20. PMID 38651651
26. Sandhu JS, Breyer B, Comiter C, et al. Incontinence after Prostate Treatment: AUA/SUFU Guideline. J Urol. Aug 2019; 202(2): 369-378. PMID 31059663
27. Breyer BN, Kim SK, Kirkby E, et al. Updates to Incontinence After Prostate Treatment: AUA/GURS/SUFU Guideline (2024). J Urol. Octubre de 2024; 212(4): 531-538. PMID 38934789
28. National Institute for Health and Care Excellence (NICE) Guideline. Urinary Incontinence and Pelvic Organ Prolapse in Women: Management. NICE Guideline. 2019..
29. Instituto Nacional para la Salud y la Excelencia Asistencial (NICE). Faecal incontinence in adults: management [CG49]. 2007;
30. Centers for Medicare & Medicaid Services (CMS). CMS Manual System: Pub 100-03 Medicare National Coverage Determinations; Transmittal 48. 2006;