Archived Policies - Surgery


Sacral Nerve Neuromodulation/Stimulation for Pelvic Floor Dysfunction

Number:SUR710.018

Effective Date:06-01-2011

End Date:09-30-2013

Coverage:

Sacral nerve neuromodulation (SNM) may be considered medically necessary for the treatment of urge incontinence, urgency-frequency, and non-obstructive urinary retention in patients when ALL of the following criteria are met:

  • documented failure or intolerance to conventional therapy (e.g., behavioral training such as bladder training, prompted voiding, or pelvic muscle exercise training, pharmacologic treatment); AND
  • a successful percutaneous test stimulation, defined as at least 50% improvement in symptoms, was performed; AND
  • condition is not related to another neurologic condition.

Other urinary and/or voiding applications of sacral nerve neuromodulation are considered experimental, investigational and unproven, 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.

Sacral nerve neuromodulation may be considered medically necessary for the treatment of fecal incontinence when ALL of the following criteria are met:

  • chronic fecal incontinence of greater than two incontinent episodes on average per week with duration greater than six months, or for more than 12 months after vaginal childbirth; AND
  • documented failure or intolerance to conventional therapy (e.g., dietary modification, the addition of bulking and pharmacologic treatment); AND
  • a successful percutaneous test stimulation, defined as at least 50% improvement in symptoms, was performed; AND
  • 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; AND
  • incontinence is not related to another neurologic condition such as peripheral neuropathy or complete spinal cord injury.

Sacral nerve neuromodulation is considered experimental, investigational and unproven in the treatment of chronic constipation or chronic pelvic pain

Description:

Sacral nerve stimulation (SNS), also referred to as sacral nerve neuromodulation (SNM), is defined as the implantation of a permanent device that modulates the neural pathways controlling bladder or rectal function.  This policy addresses use of SNS in the treatment of urinary or fecal incontinence, urinary or fecal nonobstructive retention, or chronic pelvic pain.

Treatment using SNS is one of several alternative modalities for patients with fecal or urinary incontinence (urge incontinence, significant symptoms of urgency-frequency, or 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 is kept by the patient and can be 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.

Prior to implantation of the permanent device, patients undergo a peripheral nerve stimulation test to estimate potential response to SNM.  This procedure is done with the patient under local anesthesia, using a test needle to identify the appropriate sacral nerve(s).  Once identified, a temporary wire lead is inserted through the test needle and left in place for several days.  This lead is connected to an external stimulator, which is carried by patients in their pocket or on their belt.  Patients then keep track of voiding symptoms while the temporary device is functioning. The results of this test phase are used to determine whether patients are appropriate candidates for the permanent device.  If patients show a 50% or greater reduction in incontinence frequency, they are deemed eligible for the permanent device.  According to data from the manufacturer, approximately 63% of patients have a successful peripheral nerve evaluation and are thus candidates for the permanent SNM.

The permanent device is implanted with the patient under general anesthesia.  An incision is made over the lower back, and the electrical leads are placed in contact with the sacral nerve root(s).  The wire leads are extended through a second incision underneath the skin, across the flank to the lower abdomen.  Finally, a third incision is made in the lower abdomen where the pulse generator is inserted and connected to the wire leads.  Following implantation, the physician programs the pulse generator to the optimal settings for that patient.  The patient can switch the pulse generator between on and off by placing the control magnet over the area of the pulse generator for one to two seconds.

In 1997, the Medtronic InterStim® sacral nerve stimulation system received U.S. Food and Drug Administration (FDA) approval for marketing 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.  There has also been research interest in using the device as a treatment of fecal incontinence, constipation, and chronic pelvic pain.

In 2006, the Medtronic Interstim® II System received FDA approval for treatment of intractable cases of overactive bladder and urinary retention.  The new device is smaller and lighter than the original system and is reported to be suited for those with lower energy requirements or small stature.  The device also includes updated software and programming options.  All other uses of this device (e.g., fecal incontinence or constipation) would be off-label.

NOTE: Pelvic floor stimulation refers to electrical stimulation of the pudendal nerve.  This therapy is addressed separately in medical policy DME101.037.

Rationale:

This policy was originally based on Blue Cross and Blue Shield Technology Evaluation Center (TEC) Assessments from 1998 and 2000 which focused on sacral nerve stimulation (SNS) for urge incontinence and urinary urgency/frequency, respectively.  The literature published since these Assessments, has been periodically updated using the MEDLINE database.

Urinary Incontinence

The 1998 TEC Assessment on urge incontinence included a multicenter, randomized controlled clinical trial, conducted as part of the U.S. Food and Drug Administration (FDA) approval process, which concluded that sacral nerve neuromodulation (SNM) reduced urge incontinence compared to control patients.  This well-designed trial, using standardized clinical and functional status outcomes measurements, enrolled patients with severe urge incontinence who had failed extensive prior treatments.  The magnitude of effect (approximately one half of the patients became dry, three quarters experienced at least 50% reduction in incontinence) was fairly large, probably at least as great as with surgical procedures, and larger than expected from a placebo effect or from conservative measures such as behavioral therapy or drugs.  The therapy evaluation test, in which the device is turned off and patients thus serve as their own controls, provided further evidence that the effect on incontinence is due to electrical stimulation, and demonstrates that the effect of SNS is reversible.  The cohort analysis of the clinical trial provides some evidence that the effect of SNS is maintained for up to two years. There was a high rate of adverse events reported in this clinical trial.  Most of the adverse events were minor and reversible; however, approximately one third of patients required surgical revision for pain at the operative sites or migration of the leads.  Data were inadequate on the other indications for SNS, including treatment of urge incontinence due to neurologic conditions, stress incontinence, or other chronic voiding dysfunctions.

An additional prospective randomized controlled trial of 44 patients with urge incontinence became available after the 1998 Assessment.  At six months, the implant group showed significantly greater improvement on standardized clinical outcomes, as compared to those receiving conservative therapy.  The magnitude of effect was substantial.  This study provides further evidence of the beneficial effect of SNS for urinary urge incontinence.

Sacral nerve neuromodulation for the treatment of urinary urgency and frequency was the subject of a 2000 TEC Assessment.  The data considered in this Assessment consisted of one published randomized controlled trial, a long-term, single-arm cohort study, and additional data submitted to the FDA as part of the approval process.  In the multicenter randomized clinical study of 581 patients with a variety of urinary dysfunctions, 220 had significant urgency-frequency symptoms. After six months, 83% of patients with urgency-frequency symptoms reported increased voiding volumes with the same or reduced degree of frequency.  At 12 months, 81% of patients had reached normal voiding frequency.  Compared to a control group, patients with implants reported significant improvements in quality of life, as evaluated by the SF-36 health survey.  There has also been interest in the use of sacral nerve stimulation as a treatment of interstitial cystitis, a condition characterized by painful urinary urgency and frequency.  A literature search identified three cases series of 15, 20, and 25 patients with interstitial cystitis.  These studies reported a decrease in both urgency/frequency and pain.  There is no separate policy statement for patients with interstitial cystitis, as they would be considered candidates for sacral neuromodulation therapy based on the presence of urgency and frequency alone.

A systematic review again found substantial improvement for use of SNS in treating urinary urge incontinence, with about 80% of patients achieving continence or at least a 50% improvement in incontinence symptoms.  This review also noted a repeated operation rate of 33% of implanted cases; pain and infection were the two most frequent causes.  The authors also noted that over time technical changes have been associated with decreased complication rates.

In the randomized clinical study submitted to the FDA as part of the approval process, 177 of 581 patients had urinary retention.  Patients with urinary retention reported significant improvements in terms of volume catheterized per catheterization, a decrease in the number of catheterizations per day, and increased total voided volume per day.  At 12 months post-implant, 61% of patients had eliminated the use of catheterization.  Patients with implants also reported improved quality of life.

The 2007 update identified an industry-funded study that reported 11-year (3 to 162 months) follow-up on 234 patients who had undergone placement of an implantable pulse generator.  Fifty-four percent of the patients consented and returned a mailed questionnaire.  Of these, 104 charts were available for review (44% of the total patient population).  Patients presenting with urinary frequency and/or urinary incontinence (n=83) showed significant improvements in the standard outcome measures (voids, leaks, pads).  In contrast, the 21 patients presenting with non-obstructive urinary retention, half of which were attributable to a neurological disorder, showed improvement in only one of five outcome measures (from 1.7 voids per night to 1.0).  Another retrospective case series reported 4- to 32-month follow-up on 33 patients with neurologic disease (16 multiple sclerosis, six Parkinson’s disease, two spina bifida, two cerebrovascular accident, one cerebral palsy, or six other) who underwent sacral nerve stimulation for neurogenic lower urinary tract dysfunction.  Twenty-eight of the patients (85%) had a successful test stimulation trial (> 50% reduction in leakage episodes, nocturnal, or pad usage over a period of one to three weeks) with subsequent implantation of the pulse generator.  Sacral stimulation resulted in an average 68% decrease in incontinence episodes (from 4 to 1.3 per 24 hours) and night-time voids (from 2.6 to 0.8 per night), and a 72% reduction in the number of pads used per 24 hours (from 3.5 to 1.0).  These results suggest that sacral nerve stimulation may have short-term efficacy in patients with underlying neurologic disease who have had successful test stimulation.   However, as the authors noted, “long-term efficacy of sacral nerve neuromodulation in these patients needs further research because neurologic diseases, such as multiple sclerosis (MS) and Parkinson disease (PD) are typically progressive and hence may have variable responses over time.”  Thus, longer follow-up in a larger number of patients is needed.

White et al. reported complications from a prospective longitudinal analysis of 202 patients with urge incontinence, urinary urgency, or urinary retention that had been treated with sacral nerve stimulation between 2001 and 2008.  At a mean follow-up of 37 months (range 7–84), 67 patients (30%) had experienced adverse events that required either lead or implantable pulse generator revisions.  Complications included pain (3%), device malfunction secondary to trauma (9%), infection (4%), postoperative hematoma (2%), and lead migration (6%).  In addition, 5% of patients underwent elective removal, 4% had device removal due to lack of efficacy, and 2% required removal due to battery expiration.  At the last follow-up, 172 patients (85%) had functional implanted units.

A 2009 Cochrane review described eight randomized studies on implanted devices for urinary storage and voiding dysfunction in adults.  In spite of methodological problems (generally poor quality studies), the evidence “seems clear that continuous stimulation offers benefits for carefully selected people with overactive bladder syndrome and for those with urinary retention but no structural obstruction.”  The authors concluded that while some people benefit, more research is needed to improve patient selection, to carry out the implant, and to find why so many fail.

Fecal Incontinence

At the time this policy was created, a literature search identified five cases series of 15, 16, 20, 23, and 37 patients, respectively, with fecal incontinence that were treated with sacral neuromodulation as an alternative to anal sphincter surgery.  All series included patients with a variety of etiologies of fecal incontinence, including obstetric injury, spinal cord injury, prior surgery, or idiopathic incontinence.  While sacral neuromodulation for urinary disorders focuses on patients with urinary tracts that appear to be structurally intact but functionally impaired, in contrast, the majority of patients with fecal incontinence have structural impairment of the anal sphincter.  In general, the case series reported improvements in episodes of incontinence and improvements in quality of life in those undergoing permanent implantation.  There were also improvements in objective measures, such as anal sphincter resting pressure.  The longest follow-up was 24 months.  These small case series provided inadequate data to permit scientific conclusions.  The trials of patients with urinary incontinence have typically included an arm in which symptoms were evaluated with the device turned off in a blinded manner to evaluate a placebo effect.  No such component was included in these case series of fecal incontinence.

In 2005, a small (27 patients) randomized trial of SNS reported decreased episodes of fecal incontinence and improved quality of life.  Following the crossover period, the blinded participants chose the period of stimulation (on or off) that they had preferred.  For the 19 who preferred the “on” period, episodes of incontinence fell from 1.7 to 0.7 per week.  However, for the other five subjects incontinence episodes increased from 1.7 per week during the “off” period to 3.7 during the “on” period.  Four of the 27 participants (15%) experienced an adverse event requiring removal.  These results suggest that temporary percutaneous stimulation for a two- to three-week period does not always successfully identify those for whom a permanent implant will be beneficial.  A 2007 Cochrane review identified only two controlled trials (two subjects each) in addition to the study of 27 patients described.  The authors concluded that SNS can improve continence in selected individuals, but additional studies are needed to confirm these results and also to better define patient selection criteria.

The 2009 literature update identified one randomized controlled trial and a number of case series from outside of the United States.  Tjandra and colleagues randomized 120 patients with severe fecal incontinence to SNS or best supportive therapy, consisting of pelvic floor exercises with biofeedback, bulking agents, and dietary management with a team of dietitians.  Due to the differences in treatments, this study was not blinded.  Exclusion criteria included neurologic disorders and external anal sphincter defects of more than 120 degrees of the circumference, although a “high proportion” of the patients had pudendal neuropathy.  Of the 60 patients randomized to SNS, 54 (90%) had successful test stimulation and 53 decided to proceed with implant of the pulse generator.  At baseline, the SNS group had an average of 9.5 incontinent episodes per week, and the controls had 9.2.  Both groups had an average of 3.3 days per week with incontinence.  At 12-month follow-up, episodes had decreased to one day per week with 3.1 episodes in the SNS group, but had not changed in the control group (mean 3.1 days per week with 9.4 episodes).  Complete continence was achieved in 22 of the 53 SNS patients (42%) and 13 patients (24%) improved by 75% to 99%.  None of the patients had worsening of fecal continence.  Adverse events included pain at implant site (6%), seroma (2%), and excessive tingling in the vaginal region (9%).  Matzel and colleagues reported long-term outcomes from 12 patients with severe incontinence (average of 54% incontinent episodes per week) who underwent SNS between 1994 and 1999.  In three patients the device was removed because of pain or neurologic disease; the remaining nine patients showed continued efficacy over an average 10-year follow-up (range 7–14 years).  Complete continence was achieved in five patients (42% of 12), and three patients (25%) had less than 10% incontinent episodes.  Pulse generator exchange was required in eight of the nine patients after a mean of seven years for battery fatigue.  

2010 Update

Urinary Incontinence—Chronic Pelvic Pain

Siegel and colleagues reported on a case series of 10 patients with chronic pelvic pain.  Their research interest was prompted by the concomitant decrease in pain reported by patients receiving sacral neuromodulation for urinary disorders.  The authors did not detail the etiology of the pain syndromes in their case series, but reported that 9 of the 10 patients had a decrease in pain.  These data are inadequate to permit scientific conclusions.

Fecal Incontinence

In 2010, Wexner et al. reported results from a 16-site multicenter FDA investigational device exemption (IDE) trial of sacral nerve stimulation in 120 patients with fecal incontinence.  To be included in the study, patients had to complain of chronic fecal incontinence with duration greater than six months or for more than 12 months after vaginal childbirth, defined as greater than two incontinent episodes on average per week.  All patients had failed or were not candidates for more conservative treatments such as dietary modification, the addition of bulking and antidiarrheal agents, and biofeedback therapy.  Exclusion criteria included congenital anorectal malformation; previous rectal surgery, if performed within the last 12 months (or 24 months in case of cancer); defects of the external anal sphincter over 60 degrees; chronic inflammatory bowel disease;  visible sequelae of pelvic radiation; active anal abscesses and fistulae; neurologic diseases such as clinically significant peripheral neuropathy or complete spinal-cord injury; and anatomic limitations preventing the successful placement of an electrode.  A total of 285 patients were evaluated for potential enrollment between 2002 and 2008; 133 were enrolled and underwent acute test stimulation, 129 of the 133 patients progressed to the two-week subchronic test stimulation, and 120 showed > 50% improvement during the test phase.  Of the 120 patients who received a permanent stimulator, 34 exited the study for a variety of reasons both related (i.e., lack of efficacy in six and implant site infection or skin irritation in five) and unrelated to the implant (i.e., death of a local principal investigator).  At the time of data cut-off for the manuscript, 111 patients had completed 12 months follow-up, 76 patients completed two years, and 34 patients completed three years.  Conservative analysis based on the initial 133 patients showed a 66% success rate (> 50% improvement), while analysis based on 106 patients who were considered completed cases at 12 months showed an 83% success rate.  The success rate based on the 120 patients who received a permanently implanted stimulator would fall between these two figures.  Out of 106 completed cases (88% of 120) included in the 12-month results, perfect continence (100% improvement) was reported in about 40%, while an additional 30% of patients achieved 75% or greater improvement in incontinent episodes.  Success was lower in patients with an internal anal sphincter defect (65%, n = 20) compared with patients without a defect (87%, n = 86).  There were 307 adverse events reported in 96 patients related to the device or therapy, including infection, implant site pain, hematomas, lead fractures or migrations, extremity pain or skin irritation; 26 were considered serious adverse events that were life threatening, required hospitalization, or resulted in persistent or significant disability.

Michelsen et al. published a retrospective analysis of all 177 patients who had been seen at their clinic for a percutaneous nerve evaluation test and sacral nerve stimulation.  Of these, 142 (80%) had a positive test and 126 received a permanent stimulator.  All data were presented as the median.  At a follow-up of 24 months (range, 3-72 months), 15 patients (12%) had undergone explanations for decreased function, pain, or infection.  Out of the 107 patients who still had the pulse generator in situ, 87 (81%) had improvement in the Wexner incontinence score (17 at baseline to 9).  The Wexner incontinence score improved from 16 to 10 at follow-up; similar changes were observed in subjects followed out to six years (n = 86 at two years, 51 at three years, 28 at four years, 16 at five years, and 10 at six years).  For those 49 patients who had collected three-week diaries (stopped in 2006 due to the research burden), episodes of incontinence decreased from a median of 25 at baseline to two at one-year (range, 0-47) and days of soiling decreased from a median of 16 to 5 (range, 0-21).

Sacral Nerve Stimulation for Fecal Incontinence

Study

Condition

Design

# of SNS Implants

% patients cured /n

% patients improved/n

# @ length of

Tjandra  2008 (20)

Mixed < 120˚

defect

RCT vs. Support BF

53

42% / 53

65% / 53

53 @ 12 mos

Wexner, 2010 (22)

 

Mixed < 60˚

defect

Prospective multicenter

120

 

40% / 106

 

66% /133

83% / 106

111 @ 12 mos

34 @ 3

Michelsen,

2010 (23)

Mixed

Retrospective cohort

126

 

87% / 107

86 @ 2 yrs

10 @ 6 yrs

Support/BF: supportive therapy including biofeedback; RCT: randomized controlled trial; SNS: Sacral nerve stimulator

Constipation

The 2002 literature update identified two small case series that focused on patients with slow transit constipation.  While both reported promising results, these case series of four and eight patients, respectively, were inadequate to permit scientific conclusions.  In 2008, Holzer et al. conducted a prospectively recruited cohort of 19 patients with either pathologic colonic transit time with less than two bowel movements per week or rectal outlet obstruction requiring digital manipulation for defecation.  Eight of the patients (42%) reported improvement during the test period, defined as a 50% reduction in laxative intake with more than two bowel movements per week (n=4) or rectal emptying with digital manipulation or 50% reduction in irrigation procedures (n=4).  The median follow-up was 11 months (range 2–20 months); one patient lost stimulation after a trauma dislodged an electrode.  All component scores of the Short Form (SF-36) evaluation showed significant improvements from pre-stimulation (n=19) to six months follow-up (n=7); baseline to post-treatment changes in the seven subjects who were successfully treated was not reported.

Summary

With consistent and longer-term results from two large trials in 2010 (a prospective multicenter investigational trial with 120 patients and a European cohort of 177 patients), together with a randomized controlled trial with 12-month follow-up from 2008, evidence is considered sufficient for sacral nerve stimulation to be an option for the treatment for chronic fecal incontinence in well-selected patients who have failed conservative therapy.  Therefore, it may be considered medically necessary under specific conditions.

It should be emphasized that not all patients will benefit, and that the adverse event rate for this procedure, including serious adverse events, is high.  Patients should therefore be provided with adequate information to make an informed choice regarding the potential risks and benefits of this procedure.  As concluded in the 2009 Cochrane review of sacral nerve stimulation for urinary incontinence, while some people benefit, more research is needed to improve patient selection, to carry out the implant, and to find why so many fail.

The literature on sacral nerve stimulation for constipation or chronic pelvic pain remains insufficient to evaluate the effect of this technology on health outcomes.

French implant centers provided a 2010 position statement on sacral nerve stimulation for the management of patients with fecal incontinence based on review of the evidence and a formal consensus proces,

Indications: 

  • Severe fecal incontinence, i.e., at least one or more episodes of fecal incontinence per week and/or a significant change in the patient’s quality of life;
  • Without any significant damage (>30% of the anal circumference) to the external anal sphincter, with or without previous repair;
  • Failed conservative therapy (diet, antidiarrheals and bulking agents, treatment of incomplete rectal evacuation by any means, and rehabilitation with biofeedback training;
  • Double fecal and urinary incontinence (excluding stress urinary incontinence).

Contraindications:

  • Congenital anorectal malformation;
  • Flatus incontinence alone;
  • Recent rectal surgery;
  • Present external rectal prolapse;
  • Chronic bowel diseases;
  • Chronic diarrhea;
  • Altered bowel habit associated with abdominal pain;
  • Stoma present;
  • Complete bilateral or spinal nerve lesions;
  • Inappropriate surgical candidate (i.e., bleeding, pregnancy, anatomical limitations, skin disease risking infection, psychiatric disease);

Potential Contraindications:

  • Fecal incontinence associated with constipation;
  • Non-active inflammatory bowel disease;
  • Progressive incomplete neurological disease.

Guidance from the United Kingdom’s National Institute for Clinical Excellence (NICE) concluded in 2004 that the safety and efficacy of sacral nerve stimulation for fecal incontinence appears adequate to support the use of this procedure.

Practice Guidelines from the American College of Gastroenterology (ACG) in 2004 on the diagnosis and management of fecal incontinence found limited evidence in favor of SNS.  The ACG concluded that the precise indication for SNS, its comorbidity, its long-term outcome, and efficacy remain to be defined.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

None


Medicare Coverage:

The information contained in this section is for informational purposes only.  HCSC makes no representation as to the accuracy of this information.  It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.

A national coverage position for Medicare may have been changed since this medical policy document was written.  See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

Blue Cross and Blue Shield Technology Evaluation Center (TEC) TEC Assessments. (1998); Volume 13, Tab 18.

Blue Cross and Blue Shield Technology Evaluation Center (TEC) TEC Assessments (2000) Volume 15, Tab 7.

Weil, E.H., Ruiz-Cerda, J.L., et al.  Sacral root neuromodulation in the treatment of refractory urinary urge incontinence: a prospective randomized clinical trial.  Eur Urology (2000) 37(2):161-71.

Maher, C.F., Carey, M.P., et al.  Percutaneous sacral nerve root neuromodulation for intractable interstitial cystitis.  Journal of Urology (2001) 165(3):884-6.

Rosen, H.R., Urbarz, C., et al.  Sacral nerve stimulation as a treatment for fecal incontinence. Gastroenterology (2001) 121(3):536-41.

Ganio E, Ratto C, Masin A et al. Neuromodulation for fecal incontinence: outcome in 16 patients with definitive implant. Dis Colon Rectum 2001; 44(7):965-70.

Ganio, E., Luc, A.R., et al.  Sacral nerve stimulation for treatment of fecal incontinence.  Dis Colon Rectum (2001) 44(5):619-31.

Siegel, S., Paszkiewicz, E., et al.  Sacral nerve stimulation in patient with chronic intractable pelvic pain.  Journal of Urology (2001) 166(5):1742-5.

Payne, C.K., Whitmore, K.E., et al.  Sacral neuromodulation in patients with interstitial cystitis: a multicenter clinical trial.  Neurourol Urodyn (2001) 20:554-5.

Kenefick, N.J., Vaizey, C.J., et al.  Medium term results of permanent sacral nerve stimulation for faecal incontinence.  Br J Surg (2002) 89(7):896-901.

Kenefick, N.J., Nicholls, R.J., et al.  Permanent sacral nerve stimulation for treatment of idiopathic constipation. Br J Surg (2002) 89(7):882-8.

Malouf, A.J., Wiesel, P.H., et al.  Short-term effects of sacral nerve stimulation for idiopathic slow transit constipation. World J Surg (2002) 26(2):166-70.

Comiter, C.V.  Sacral neuromodulation for the symptomatic treatment of refractory interstitial cystitis: a prospective study. J Urol (2003) 169(4):1369-73.

Matzel, K.E., Kamm, M.A., et al.  Sacral spinal nerve stimulation for faecal incontinence: multicentre study. Lancet (2004) 363(9417):1270-6.

National Institute for Clinical Evidence (NICE). Sacral nerve stimulation for faecal incontinence. Interventional Procedure Guidance 99; (2004).   <http://www.nice.org.uk> (accessed June 14 2010).

Rao, S.S.  American College of Gastroenterology Practice Parameters Committee.  Diagnosis and management of fecal incontinence.  American College of Gastroenterology Practice Parameters Committee. Am J Gastroenterol (2004) 99(8):1585-604. <http://www.gi.org> (accessed June 14 2010).

Leroi, A.M., Parc, Y., et al.  Efficacy of sacral nerve stimulation for fecal incontinence: results of a multicenter double-blind crossover study.  Ann Surg (2005) 242(5):662-9.

Brazzelli, M., Murray, A.  Efficacy and safety of sacral nerve stimulation for urinary urge incontinence: a systematic review. J Urol (2006) 175(3 pt 1):835-41.

Sutherland, S, E., Lavers, A., et al.  Sacral nerve stimulation for voiding dysfunction: One institution's 11-year experience. Neurourol Urodyn (2007) 26(1):19-28.

Wallace, P.A., Lane, F.L., et al.  Sacral nerve neuromodulation in patients with underlying neurologic disease.  Am J Obstet Gynecol (2007) 197(1):96.

Mowatt, G., Glazener, C., et al. Sacral nerve stimulation for fecal incontinence and constipation in adults: a short version Cochrane review.   Neurourol Urodyn (2008) 27(3):155-61.

Tjandra, J.J., Chan, M.K., et al.  Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: a randomized, controlled study. Dis Colon Rectum (2008) 51(5):494-502.

Holzer, B., Rosen, H.R., et al.  Sacral nerve stimulation in patients with severe constipation. Dis Colon Rectum (2008) 51(5):524-29.

Matzel, K.E., Lux, P., et al.  Sacral nerve stimulation for faecal incontinence: Long-term outcome. Colorectal Dis (2008) 11(6):636-41.

White, W.M., Mobley, J.D., 3rd, et al.  Incidence and Predictors of Complications With Sacral Neuromodulation. Urology (2009) 73(4):731-5.

Herbison, G.P., and Arnold, E.P.  Sacral neuromodulation with implanted devices for urinary storage and voiding dysfunction in adults. Cochrane Database Syst Rev (2009) (2):CD004202.

Leroi, A.M., Damon, H., et al.  Sacral nerve stimulation in faecal  incontinence: position statement based on a collective experience.  Colorectal Dis (2009) 11(6):572-83.

Wexner, S.D., Coller, J.A., et al.  Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg (2010) 251(3):441-9.

Michelsen, H.B., Thompson-Fawcett, M., et al.  Six years of experience with sacral nerve stimulation for fecal incontinence. Dis Colon Rectum (2010) 53(4):414-21.

Sacral Nerve Neuromodulation/Stimulation for Pelvic Floor Dysfunction.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2010 May) Surgery 7.01.69.

Medtronic. Summary of Multi-Center Clinical Study. Medtronic Neurological, Minneapolis, MN. < www.interstim.com>.  (accessed June 2010).

Policy History:

6/1/2011          CPT/HCPCS code(s) updated                             

11/1/2010        Document updated with literature review. The following was added to the conditional criteria for the treatment of urge incontinence, urgency-frequency, and non-obstructive urinary retention:  1) the patient is an appropriate surgical candidate (determined by the treating physician to be unable to tolerate surgery); 2) a successful percutaneous test stimulation, defined as at least 50% improvement in symptoms, was performed; and 3) condition is not related to a neurologic condition.  The following was added for the treatment of fecal incontinence:  Sacral nerve neuromodulation is considered conditionally medically necessary for the treatment of fecal incontinence.  No further review status was removed from policy.

12/1/2009        Policy reviewed and references updated; no change in coverage position.

12/1/2007        Revised/updated entire document

8/15/2003        Revised/updated entire document

5/2002             Revised/updated entire document

1/2000             Revised/updated entire document

9/1999             New Medical Document

Archived Document(s):

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