Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Stress Urinary Incontinence (Remodelación por radiofrecuencia de tejido transvaginal y transuretral para tratar la incontinencia urinaria de esfuerzo)

Policy Number: MP 4.034

Fecha de entrada en vigencia: 9/1/2025

Política

Transvaginal radiofrequency bladder neck suspension as a treatment of urinary stress incontinence is considered investigational, as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Transurethral radiofrequency tissue remodeling as a treatment of urinary stress incontinence is considered investigational, as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Referencias cruzadas

• MP 1.033 Sacral Nerve Neuromodulation-Stimulation and Pelvic Floor Stimulation Devices
• MP 2.064 Biofeedback and Neurofeedback Therapy
• MP 4.012 Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence

Product variation

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

FEP PPO - Consulte el Manual de Políticas Médicas del FEP. El Manual de Políticas Médicas del FEP se puede encontrar en: https://www.fepblue.org/benefit-plans/medical-policies-and-utilization-management-guidelines/medical-policies

Descripción/antecedentes

Radiofrequency (RF) tissue remodeling with specially designed devices has been explored as a minimally invasive treatment option for urinary stress incontinence. It involves using nonablative levels of RF energy to shrink and stabilize the endopelvic fascia.

Urinary stress incontinence, defined as the involuntary loss of urine from the urethra due to an increase in intra-abdominal pressure, is a common condition, affecting an estimated 15 million women in the U.S. Conservative therapy usually includes pelvic floor muscle exercises and behavioral therapy.

Biofeedback, pelvic electrical stimulation, medications or periurethral bulking agents such as collagen might also be tried. Various surgical options are considered when conservative therapy fails, including most prominently various types of bladder suspension procedures, which intend to reduce bladder neck and urethra hypermobility by tightening the endopelvic fascia.

Recently, the use of nonablative levels of RF energy has been investigated as a technique to shrink and stabilize the endopelvic fascia, thus improving the support for the urethra and bladder neck. Two RF devices have been specifically designed for the treatment of urinary stress incontinence, which may be performed as outpatient procedures under general anesthesia.

SURx transvaginal system

This involves making an incision through the vagina lateral to the urethra, exposing the endopelvic fascia. Radiofrequency energy is then applied over the endopelvic fascia in a slow sweeping manner, resulting in blanching and shrinkage of the tissue. As of 2006, the SURx device is no longer marketed in the U.S.

Lyrette™ (formerly the Renessa^® procedure)

The procedure involves passing a radiofrequency probe through the urethral opening into the urethra and then into the bladder. Once the probe is in position, a small balloon is inflated to keep it stationary during the procedure. Radiofrequency energy is used to generate controlled heat at low temperatures in tissue targets within the lower urinary tract. The heat denatures collagen in the tissue at multiple small treatment sites.

Fundamento

Transvaginal and transurethral radiofrequency tissue remodeling involves the use of nonablative levels of radiofrequency energy to shrink and stabilize the endopelvic fascia and are potential minimally invasive treatment options for urinary stress incontinence. There is insufficient evidence from well-conducted, randomized, controlled trials that either of these treatments improves the net health outcome compared to a sham procedure or another treatment for stress urinary incontinence. The safety and long-term efficacy on health outcomes is limited, and randomized controlled studies with longer follow-up are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Definiciones

• 510(K) Approval refers to section 510(k) of the Food, Drug and Cosmetic Act. Under 510(k), before a manufacturer can market a medical device in the United States, they must demonstrate to FDA’s satisfaction that it is substantially equivalent (as safe and effective) to a device already on the market.
• Mixed Incontinence is a combination of stress and urge incontinence.
• Overflow Incontinence is characterized by small frequent voidings due to overfilling of the bladder or to a bladder with pathologically decreased volume.
• Pessary is a device inserted into the vagina to function as a support structure for the uterus.
• Stress Incontinence is an involuntary loss of urine that occurs during physical activity, such as coughing, sneezing, laughing or exercise. This incontinence occurs as a result of weakened pelvic muscles that support the bladder and urethra, or because of malfunction of the urethral sphincter.
• Urge Incontinence is a condition characterized by a strong desire to urinate immediately before an involuntary bladder contraction with a loss of a large amount of urine.

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 exija 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. These polices are not a guarantee of coverage or payment. 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: Es posible que esta lista de códigos no sea exhaustiva y que los códigos estén 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. Los códigos deben estar en orden numérico.

Transurethral radiofrequency tissue remodeling as a treatment of urinary stress incontinence is considered investigational; therefore, not covered:

Transvaginal radiofrequency bladder neck suspension as a treatment of urinary stress incontinence is considered investigational; therefore, not covered:

Referencias

1. Dmochowski RR, Avon M, Ross J et al. Transvaginal radio frequency treatment of the endopelvic fascia: a prospective evaluation for the treatment of genuine stress urinary incontinence. J Urol 2003; 169(3):1028-32. PMID: 12576838
2. Ross JW, Galen DI, Abbott K et al. A prospective multisite study of radiofrequency bipolar energy for treatment of genuine stress incontinence. J Am Assoc Gynecol Laparosc 2002; 9(4-Jan):493-9. PMID: 12386362
3. McDougall EM, Heidorn CA, Portis AJ et al. Laparoscopic bladder neck suspension fails the test of time. J Urol 1999; 162(6):2078-81. PMID: 10569574
4. Buchsbaum GM, McConville J, Korni R et al. Outcome of transvaginal radiofrequency for treatment of women with stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2007; 18(3):263-5. PMID: 16788852
5. Appell RA, Juma S, Wells WG et al. Transurethral radiofrequency energy collagen micro-remodeling for the treatment of female stress urinary incontinence. Neurourol Urodyn 2006; 25(4):331-6. PMID: 16673379
6. Lenihan JP. Comparison of the quality of life after nonsurgical radiofrequency energy tissue micro-remodeling in premenopausal and postmenopausal women with moderate-to-severe stress urinary incontinence. Am J Obstet Gynecol 2005; 192(6-Jan):1995-2001. PMID: 15970873
7. Appell RA, Singh G, Klimberg IW et al. Nonsurgical, radiofrequency collagen denaturation for stress urinary incontinence: retrospective 3-year evaluation. Expert Rev Med Devices 2007; 4(4):455-61. PMID: 17605681
8. Elser DM, Mitchell GK, Miklos JR et al. Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 12-month results from a prospective long-term study. J Minim Invasive Gynecol 2009; 16(1):56-62. PMID: 19013110
9. Elser DM, Mitchell GK, Miklos JR et al. Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women month results from a prospective long-term study. Neurourol Urodyn 2010; 29(8):1424-8. PMID: 20976817
10. Elser DM, Mitchell GK, Miklos JR et al. Nonsurgical transurethral radiofrequency collagen denaturation: results at three years after treatment. Adv Urol 2011; 2011:872057. PMID: 22190917
11. NCT01455779 Lyrette: Renewing Continence Objective and Subjective Efficacy Study (ROSE)
12. Sand PK, Owens GM, Black EJ, Anderson LH, Martinson MS. Cost effectiveness of radiofrequency microremodeling for stress urinary incontinence. Int Urogynecol J. 2014;25(4):517-523. PMID: 24108392
13. Kang D, Han J, Neuberger NM, et al. "Transurethral radiofrequency collagen denaturation for the treatment of women with urinary incontinence." Cochrane Database of Systematic Reviews 3 (2015). PMID: 25785555
14. Lukacz, E. Female urinary incontinence: Treatment. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated May 25, 2023
15. Kobashi K, Albo M, Dmochowski R, et al., "Surgical Treatment of Female Stress Urinary Incontinence: AUA/SUFU Guideline". Journal of Urology. 198: 875-883. PMID: 28625508
16. Davila GW. Review Article Nonsurgical outpatient therapies for the management of female stress urinary incontinence: long-term effectiveness and durability. Advances in Urology 2011. PMID: 21738529
17. Dillon B, Dmochowski R. Radiofrequency for the treatment of stress urinary incontinence in women. Current Urology Reports 2009; 10: 369-374. PMID: 19709484
18. ACOG Practice Bulletin No. 155: Urinary Incontinence in Women. Obstet Gynecol. Nov 2015; 126(5): e66-e81.PMID 26488524
19. Stachowicz AM, Hoover ML, Karram MM. Clinical utility of radiofrequency energy for female genitourinary dysfunction: past, present, and future. Int Urogynecol J. 2021 Jun;32(6):1345-1350. PMID 33661319
20. Brasil C, Sodré D, Lemos A, et al. Radiofrequency in the Treatment of urinary incontinence of female stress: a pilot randomized clinical trial. Research Square (Research Square). Published online February 9, 2024. doi:10.21203/rs.3.rs-3888375/v1
21. Elfaki S, Hassan S. Radiofrequency in Cosmetic Gynecology, Literature Review 2018-2023. Obstetrics & Gynecology Open Access. 2024;8(1). doi:10.29011/2577-2236.100182
22. Lukacz, E. Female Urinary Incontinence: Treatment. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; Updated February 22, 2024. Literature review current through September 2024.
23. Blue Cross Blue Shield Association Medical Policy Reference Manual. 2.01.60, Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence. Archived March 2013.

Historial de políticas

• MP 4.034 - 03/28/2025 New policy created for MA; Full Adoption

Programas de beneficios de atención de la salud emitidos o administrados por Capital Blue Cross y/o sus subsidiarias, Capital Advantage Insurance Company^®, Capital Advantage Assurance Company^® y Keystone Health Plan^® Central. Licenciatarios independientes de Blue Cross BlueShield Association. Comunicaciones emitidas por Capital Blue Cross en su condición de administrador de programas y relaciones con los proveedores para todas las empresas.