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Treatment using sacral nerve neuromodulation (SNM), also known as indirect sacral nerve stimulation, is one of several alternative modalities for patients with fecal or urinary incontinence (urge incontinence, significant symptoms of urgency-frequency, nonobstructive urinary retention) who have failed behavioral (e.g., prompted voiding) and/or pharmacologic therapies. 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 and is a prominent symptom of interstitial cystitis. Urinary retention is the inability to completely empty the bladder of urine. Fecal incontinence can arise from a variety of mechanisms, including rectal wall compliance, efferent and afferent neural pathways, central and peripheral nervous systems, and voluntary and involuntary muscles. Fecal incontinence is more common in women, due mainly to muscular and neural damage that may occur during vaginal delivery.

The SNM device consists of an implantable pulse generator that delivers controlled electrical impulses. This 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. A console programmer is kept by the physician and used to adjust the settings of the pulse generator.

Several sacral nerve neuromodulation devices have been approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process. The InterStim™ and InterStim II® System have been approved for the treatment of urinary retention and symptoms of overactive bladder in patients who have failed or could not tolerate more conservative treatments.  These products have also been approved for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments. The Axonics SNM System® has received FDA approval for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency in patients who have failed or could not tolerate more conservative treatments.  

I.   Urinary Incontinence and Nonobstructive Retention

• Temporarily implanted sacral nerve neuromodulation  A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria are met:
  • Diagnosis of at least 1 of the following:
    • Urge incontinence; or
    • Urgency-frequency syndrome; or
    • Nonobstructive urinary retention; or
    • Overactive bladder; AND
  • Documented failure or intolerance of BOTH of the following conventional conservative therapies:
    • Behavioral (e.g. bladder training, prompted voiding, or pelvic muscle exercise training; and
    • Pharmacologic (e.g. anti-cholinergic drugs [oxybutynin, hyoscyamine], or a combination of an anticholinergic and a tricyclic antidepressant [imipramine]); AND
  • The patient is an appropriate surgical candidate; AND
  • Incontinence is not related to a neurologic condition.
• Permanently implanted sacral nerve neuromodulation  Permanent implantation of a sacral nerve neuromodulation device may be considered MEDICALLY NECESSARY AND APPROPRIATE when BOTH of the following criteria are met:
  • ALL of the criteria (1 – 4 above) for temporarily implanted sacral nerve neuromodulation for urinary incontinence and nonobstructive retention are met; AND
  • A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 48 hours.
• Sacral nerve neuromodulation for all other urinary/voiding indications is considered EXPERIMENTAL/INVESTIGATIVE, 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, other types of chronic voiding dysfunction) due to a lack of evidence demonstrating an impact on improved health outcomes.

II.  Fecal Incontinence

• Temporarily implanted sacral nerve neuromodulation  A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria are met:
  • Chronic fecal incontinence of more than 2 incontinent episodes on average per week for more than 6 months or for more than 12 months after vaginal childbirth; AND
  • Documented failure or intolerance to BOTH of the following conventional conservative therapy:
    • Dietary modification; and
    • Pharmacologic treatment; AND
  • The patient is an appropriate surgical candidate; AND
  • The condition is not related to an anorectal malformation (e.g., congenital anorectal malformation; defects of the external anal sphincter over 60°; visible sequelae of pelvic radiation; active anal abscesses and fistulae) or chronic inflammatory bowel disease; AND
  • Incontinence is not related to a neurologic condition; AND
  • No rectal surgery in the previous 12 months or, in the case of cancer, no rectal surgery in the past 24 months.
• Permanently implanted sacral nerve neuromodulation  Permanent implantation of a sacral nerve neuromodulation device may be considered MEDICALLY NECESSARY AND APPROPRIATE when BOTH of the following are met:
  • ALL of the criteria (1 – 6 above) for temporarily implanted sacral nerve neuromodulation for fecal incontinence are met; AND
  • A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 48 hours.
• Sacral nerve neuromodulation is considered EXPERIMENTAL/INVESTIGATIVE for the treatment of chronic constipation or chronic pelvic pain due to a lack of evidence demonstrating an impact on improved health outcomes.