Medical policy: Sacral Nerve Neuromodulation-Stimulation

Número de política: MP 1.033

Fecha de entrada en vigor: 5/1/2026

Política

Urinary incontinence and non-obstructive retention

A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead may be considered medically necessary in individuals who meet all of the following criteria:

Criteria A

1. There is a diagnosis of at least one of the following:
   • Urge incontinence
   • Urgency-frequency syndrome
   • Non-obstructive urinary retention
   • Overactive bladder
2. There is documented failure or intolerance to at least two conventional conservative therapies (e.g., behavioral training such as bladder training, prompted voiding, or pelvic muscle exercise training; pharmacologic treatment for at least a sufficient duration to fully assess its efficacy; and/or surgical corrective therapy).
3. The member is an appropriate surgical candidate.
4. La incontinencia no está relacionada con una afección neurológica.

Criteria B

Permanent implantation of a sacral nerve neuromodulation device may be considered medically necessary in individuals who meet all of the following criteria:

1. All of criteria A.1 and A.2 above are met.
2. A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 48 hours.

Other urinary/voiding applications of sacral nerve neuromodulation are considered investigational, including but not limited to treatment of stress incontinence or urge incontinence due to a neurologic condition (e.g., detrusor hyperreflexia, multiple sclerosis, spinal cord injury, or other types of chronic voiding dysfunction). No hay pruebas suficientes para apoyar una conclusión general con respecto a los resultados o beneficios para la salud asociados con este procedimiento.

Fecal incontinence

A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead may be considered medically necessary in individuals who meet all of the following criteria:

Criteria A

1. Existe un diagnóstico de incontinencia fecal crónica de más de dos (2) episodios de incontinencia en promedio por semana durante más de seis (6) meses o más de 12 meses después de un parto vaginal.
2. Hay fracaso documentado o intolerancia a la terapia conservadora convencional (p. ej., modificación de la dieta, adición de aumento de volumen y tratamiento farmacológico) durante al menos un período suficiente para evaluar plenamente su eficacia.
3. El individuo es un candidato quirúrgico apropiado.
4. The condition is not related to an anorectal malformation (e.g., congenital anorectal malformation; defects of the external anal sphincter over 60 degrees; visible sequelae of pelvic radiation; active anal abscesses and fistulae) or chronic inflammatory bowel disease.
5. La incontinencia no está relacionada con una afección neurológica.
6. The member has had no rectal surgery in the previous 12 months or, in the case of cancer, the individual has not had rectal surgery in the past 24 months.

Criteria B

Permanent implantation of a sacral nerve neuromodulation device may be considered medically necessary in individuals who meet all of the following criteria:

• All of criteria A.1 through A.6 above are met.
• A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 48 hours.

Sacral nerve neuromodulation is investigational in the treatment of chronic constipation or chronic pelvic pain. No hay pruebas suficientes para apoyar una conclusión general con respecto a los resultados o beneficios para la salud asociados con este procedimiento.

Directrices de la política

The International Continence Society has defined overactive bladder syndrome (OAB) as “urinary urgency, usually accompanied by increased daytime frequency and/or nocturia, with urinary incontinence (OAB-wet) or without (OAB-dry), in the absence of urinary tract infection or other detectable disease” (available at International Continence Society glossary).

Referencias cruzadas

• MP 1.134 Percutaneous and implantable tibial nerve stimulation
• MP 2.398 Biofeedback as a treatment of fecal incontinence or constipation
• MP 6.024 Pelvic floor stimulation as a treatment of urinary and fecal incontinence

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 - Consulte el Manual de Políticas Médicas de FEP.

Descripción/antecedentes

Tratamiento

Treatment using sacral nerve neuromodulation, also known as indirect sacral nerve stimulation, is one of several alternative modalities for patients with urinary or fecal incontinence (urge incontinence, significant symptoms of urgency-frequency, nonobstructive urinary retention) who have failed behavioral (e.g., prompted voiding) and/or pharmacologic therapies.

The sacral nerve neuromodulation device consists of an implantable pulse generator that delivers controlled electrical impulses. The pulse generator is attached to wire leads that connect to the sacral nerves, most commonly the S3 nerve root. Two external components of the system help control the electrical stimulation. A control magnet, kept by the patient, is used to turn the device on or off. Un programador de consola, que conserva el médico, se utiliza para ajustar la configuración del generador de pulsos.

Before implantation of the permanent device, patients undergo an initial testing phase to estimate potential response to treatment. El primer tipo de prueba que se desarrolló fue la evaluación percutánea del nervio (PNE, por sus siglas en inglés). Este procedimiento se realiza con el paciente bajo anestesia local, utilizando una aguja de prueba para identificar el nervio o los nervios sacros apropiados. Once identified, a temporary wire lead is inserted through the test needle and left in place for 4 to 7 days. This lead is connected to an external stimulator, which is carried by patients in their pocket or on their belt. Los resultados de esta fase de prueba se utilizan para determinar si los pacientes son candidatos adecuados para el dispositivo permanente. If patients show a 50% or greater reduction in symptom frequency, they are deemed eligible for the permanent device.

The second type of testing is a two-stage surgical procedure. In the first stage, a quadripolar-tined lead is implanted (stage 1). The testing phase can last as long as several weeks, and if patients show a 50% or greater reduction in symptom frequency, they can proceed to stage 2 of the surgery, which is permanent implantation of the neuromodulation device. The two-stage surgical procedure has been used in various ways. These include its use instead of PNE, for patients who failed PNE, for patients with an inconclusive PNE, or for patients who had a successful PNE to refine patient selection further.

El dispositivo permanente se implanta con el paciente bajo anestesia general. Los cables eléctricos se colocan en contacto con la(s) raíz(es) del nervio sacra a través de una incisión en la parte baja de la espalda, y los cables del electrodo se extienden a través de una segunda incisión debajo de la piel, a través del flanco hasta la parte inferior del abdomen. Finalmente, se realiza una tercera incisión en la parte inferior del abdomen, donde se inserta el generador de pulsos y se conecta a los cables del electrodo. Después de la implantación, el médico programa el generador de pulsos con los ajustes óptimos para ese paciente. El paciente puede encender y apagar el generador de impulsos colocando el imán de control sobre el área del generador de impulsos durante 1 a 2 segundos.

Esta revisión de la evidencia no aborda la estimulación del suelo pélvico, que se refiere a la estimulación eléctrica del nervio pudendo. La estimulación del suelo pélvico se aborda por separado (ver MP 2.398). Además, esta revisión no aborda los dispositivos que proporcionan estimulación directa del nervio sacro en individuos con lesiones medulares.

Situación reglamentaria

In 1997, the InterStim^® Sacral Nerve Stimulation system (Medtronic) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process for the indication of urinary urge incontinence in patients who have failed or could not tolerate more conservative treatments. In 1999, the device received FDA approval for the additional indications of urgency-frequency and urinary retention in patients without mechanical obstruction. In 2006, the InterStim II^® System (Medtronic) was approved by FDA through the premarket approval process for treatment of intractable cases of overactive bladder and urinary retention. The new device is smaller and lighter than the original and is reported to be suited for those with lower energy requirements or small stature. The device also includes updated software and programming options.

In 2011, the InterStim^® System was approved by FDA through the premarket approval process for the indication of chronic fecal incontinence in patients who have failed or could not tolerate more conservative treatments.

The InterStim^® device has not been specifically approved by FDA for treatment of chronic pelvic pain.

In 2020, the InterStim X™ device was approved by the FDA. Esta última generación del dispositivo InterStim no requiere recarga y tiene una duración de la batería de al menos 10 años y hasta 15 años si se usa en una configuración de bajo consumo.

El dispositivo InterStim no ha sido aprobado específicamente por la FDA para el tratamiento del dolor pélvico crónico.

En 2019, el Sistema de Neuromodulación Sacral de Axonics^® (Axonics) recibió la aprobación previa a la comercialización de la FDA tanto para la incontinencia fecal como para el tratamiento de la retención urinaria y los síntomas de vejiga hiperactiva. Este sistema tiene una batería recargable que tiene una vida útil del dispositivo de 15 años después de la implantación.

In 2023, the Virtis™ Sacral Neuromodulation System (NuVasive) was approved by the FDA for treatment of urinary retention and symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency in patients who have failed more conservative treatments. Código de producto de la FDA: EZW.

Fundamento

Summary of evidence

For individuals with urinary incontinence who have failed conservative treatment and who receive sacral nerve neuromodulation (SNM), the evidence includes randomized controlled trials, systematic reviews, and case series. Los resultados relevantes son los síntomas, los eventos mórbidos y la morbilidad relacionada con el tratamiento. Results from the randomized controlled trials and case series with long-term follow-up suggest that SNM reduces symptoms of urge incontinence, urgency-frequency syndrome, nonobstructive urinary retention, and overactive bladder in selected patients. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals with fecal incontinence who have failed conservative treatment and who receive SNM, the evidence includes randomized controlled trials and systematic reviews. Los resultados relevantes son los síntomas, los eventos mórbidos y la morbilidad relacionada con el tratamiento. Aunque relativamente pequeños, los ensayos disponibles tuvieron un bajo riesgo de sesgo y demostraron mejorías en la incontinencia en comparación con las alternativas. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals with constipation who have failed conservative treatment and who receive SNM, the evidence includes randomized controlled trials and systematic reviews. Los resultados relevantes son los síntomas, los eventos mórbidos y la morbilidad relacionada con el tratamiento. The available trials have not consistently reported improvements in outcomes with SNM. Additional studies are needed to demonstrate the health benefits of this technology. La evidencia es insuficiente para determinar los efectos de esta tecnología en los resultados de salud.

Para las personas con dolor pélvico crónico que reciben SNM, la evidencia se limita a series de casos. Los resultados relevantes son los síntomas, los eventos mórbidos y la morbilidad relacionada con el tratamiento. La evidencia es insuficiente para determinar los efectos de esta tecnología en los resultados de salud.

Definiciones

Pudendal refers to external female genitalia.

Stress incontinence is the involuntary leaking of urine during activities that increase pressure inside the abdomen, such as coughing, sneezing, or jogging.

Urge incontinence is defined as leakage of urine when there is a strong urge to void.

Urgency-frequency is an uncontrollable urge to urinate, resulting in very frequent, small volumes.

Urinary retention is the inability to completely empty the bladder 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 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 del miembro, 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.

Cubierto cuando es médicamente necesario

Referencias

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