This document addresses sacral nerve stimulation (SNS), percutaneous tibial nerve stimulation (PTNS), and implantable tibial nerve stimulation in individuals with urinary retention or chronic, refractory urinary and fecal incontinence.

Urinary incontinence is the inability to hold urine in the bladder and can be due to loss of voluntary control over the urinary sphincters resulting in the involuntary passage of urine. Urinary retention is the inability to completely empty the bladder. Fecal incontinence (FI) is a chronic inability to control bowel function for elimination.

Note: This document does not address the use of SNS for the treatment of neurogenic bladder secondary to spinal cord injury. For information about treatment of neurogenic bladder, see:

• CG-SURG-08 Sacral Nerve Stimulation as a Treatment of Neurogenic Bladder Secondary to Spinal Cord Injury

Note: This document does not address the use of transcutaneous tibial nerve stimulation. For information about transcutaneous tibial nerve stimulation, see:

• CG-DME-04 Electrical Nerve Stimulation, Transcutaneous, Percutaneous

Note: Please see the following related documents for additional information:

• MED.00125 Biofeedback and Neurofeedback
• SURG.00010 Treatments for Urinary Incontinence
• SURG.00056 Transanal Radiofrequency Treatment of Fecal Incontinence
• SURG.00102 Artificial Anal Sphincter for the Treatment of Severe Fecal Incontinence

Note: The use of physical therapy and botulinum toxin is not addressed in this document. Refer to applicable guidelines used by the plan.

Clinical Indications

Medically Necessary:

I. Sacral Nerve Stimulation for Urinary Urge Incontinence, Urgency/Frequency, and Retention

A trial or temporary sacral nerve stimulator is considered medically necessary when the following criteria are met (A and B):

1. Any of the following are present and not due to a neurological condition:
   1. Urinary urge incontinence; or
   2. Urinary urgency/frequency; or
   3. Non-obstructive urinary retention;
      and
2. Criteria 1 and 2 are met:
   1. Clinically significant symptoms are present (for example, frequency or severity impacts ability to work or participate in activities outside of the home); and
   2. Symptoms are refractory to, or individual could not tolerate, conservative treatment (for example, medication, pelvic floor muscle exercises, pelvic floor physical exercises with biofeedback, bladder training, or intermittent catheterizations for non-obstructive urinary retention) for at least a sufficient duration to fully assess treatment effect.*

A permanent sacral nerve stimulator is considered medically necessary when criteria A and B are met:

1. The individual has met criteria above for a trial or temporary sacral nerve stimulator; and
2. The individual has demonstrated a successful trial of the temporary sacral nerve stimulator, defined as:
   1. For urinary urge incontinence: At least 50% reduction in one of the following: daily incontinence episodes, severity of the episodes, or the number of pads/diapers used per day; or
   2. For urinary urgency/frequency: At least 50% reduction in the number of voids daily, or 50% increase in volume voided per void; or
   3. For urinary retention: At least a 50% reduction in catheter volume/catheterization.

* Note: The time frame for prior conservative treatment measures to demonstrate a refractory response is generally considered to be 2 to 3 months’ duration, subject to individual variability.

II. Sacral Nerve Stimulation for Fecal Incontinence

A trial or temporary sacral nerve stimulator is considered medically necessary when the following criteria are met (A and B):

1. Treatment is for fecal incontinence; and
2. The following are met (1 and 2):
   1. Incontinent episodes average greater than or equal to 2 per week for 6 months;** and
   2. Symptoms are refractory to, or individual could not tolerate, conventional therapy (for example, dietary modification, addition of bulking agents, pharmacologic treatment) for at least a sufficient duration to fully assess treatment effect.*

A permanent sacral nerve stimulator is considered medically necessary when the following criteria are met:

1. The individual has met the criteria above for a trial or temporary sacral nerve stimulator; and
2. The individual has had a successful trial of the temporary sacral nerve stimulator, defined as at least a 50% improvement in symptoms.

Notes:
* The time frame for prior conservative treatment measures to demonstrate a refractory response is generally considered to be 2 to 3 months’ duration, subject to individual variability.
** After vaginal childbirth, most individuals who experience fecal incontinence in the immediate postpartum period will see improvement in symptoms in the year following delivery.

III. Replacement and Revision of Sacral Nerve stimulators

Replacement or revision of an implanted sacral nerve stimulator (with or without lead changes) is considered medically necessary when the current implanted device is no longer functioning appropriately.

Not Medically Necessary:

1. A sacral nerve stimulator is considered not medically necessary when the medically necessary criteria above have not been met.

Replacement or revision of an implanted sacral nerve stimulator is considered not medically necessary when the medically necessary criteria above for replacement or revision have not been met.

IV. Percutaneous or Implantable Tibial Nerve Stimulation

Medically Necessary:

An initial 12-week trial of percutaneous tibial nerve stimulation is considered medically necessary when the following criteria are met (A and B):

1. Any of the following are present for at least 3 months, and not due to a neurological condition:
   1. Urinary urge incontinence; or
   2. Urinary urgency/frequency; or
   3. Non-obstructive urinary retention;
      and
2. Criteria 1 and 2 below are met:
   1. Clinically significant symptoms are present (for example, frequency, or severity impacts ability to work or participate in activities outside of the home); and
   2. Symptoms are refractory to, or individual could not tolerate, conservative treatment (for example, medication, pelvic floor muscle exercises, pelvic floor physical exercises with biofeedback, bladder training, or intermittent catheterizations for non-obstructive urinary retention) for at least a sufficient duration to fully assess treatment effect.*

* Note: The time frame for prior conservative treatment measures to demonstrate a refractory response is generally considered to be 2 to 3 months’ duration, subject to individual variability.

Continuation of percutaneous tibial nerve stimulation with monthly treatment is considered medically necessary when the following criteria are met (A and B):

1. An initial 12-week trial demonstrated improved urinary dysfunction meeting treatment goals, defined as:
   1. For urinary urge incontinence: At least 50% reduction in one of the following: daily incontinence episodes, severity of the episodes, or the number of pads/diapers used per day; or
   2. For urinary urgency/frequency: At least 50% reduction in the number of voids daily, or 50% increase in volume voided per void; or
   3. For urinary retention: At least a 50% reduction in catheter volume/catheterization.
      and
2. Annual evaluation indicates that the condition for which the treatment was initiated is still present.

An implantable tibial nerve stimulator is considered medically necessary for individuals when the (A and B) criteria are met (A and B):

1. The individual has met criteria above for evaluation for a temporary percutaneous tibial nerve stimulator; and
2. The individual has demonstrated a successful response to a percutaneous tibial nerve stimulation defined as:
   1. For urinary urge incontinence: At least 50% reduction in one of the following: daily incontinence episodes, severity of the episodes or the number of pads/diapers used per day; or
   2. For urinary urgency/frequency: At least 50% reduction in the number of voids daily, or 50% increase in volume voided per void; or
   3. For urinary retention: At least a 50% reduction in catheter volume/catheterization.

Replacement or revision of a percutaneous or implantable tibial nerve stimulator (with or without lead changes) is considered medically necessary when the current implanted device is no longer functioning appropriately.

Not Medically Necessary:

Percutaneous or implantable tibial nerve stimulation is considered not medically necessary when the medically necessary criteria above have not been met.

Replacement or revision of a percutaneous or implantable tibial nerve stimulator is considered not medically necessary when the medically necessary criteria above for replacement or revision have not been met.