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.

This document addresses sacral nerve stimulation (SNS) and percutaneous tibial nerve stimulation (PTNS) in those with chronic, refractory urinary and fecal incontinence as well as urinary retention.

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

• DRUG.00006 Botulinum Toxin
• 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
• CG-Surg-08 Sacral Nerve Stimulation as a Treatment of Neurogenic Bladder Secondary to Spinal Cord Injury

Sacral nerve stimulation (SNS): Urinary incontinence and retention

Medically Necessary:

• Placement of a temporary sacral nerve stimulator is considered medically necessary after a positive peripheral nerve evaluation test for urinary urge incontinence and urinary urgency/frequency, when all of the following are met:
  • The individual has experienced urge incontinence for a minimum of 12 months duration that is not due to a neurologic condition and has resulted in significant disability (frequency or severity impacts ability to work or participate in activities outside of the home); and
  • The individual is refractory or could not tolerate a minimum of 12 consecutive months of conservative treatments (exercises, medication); and
  • The individual is an appropriate surgical candidate for permanent implantation.
• Placement of a temporary sacral nerve stimulator is considered medically necessary after a positive peripheral nerve evaluation test for non-obstructive urinary retention when the following are met:
  • The individual is an appropriate surgical candidate for permanent implantation;
  • The individual has experienced urinary retention for a minimum of 12 months duration that is not due to a neurologic condition and has resulted in significant disability (frequency or severity impacts ability to work or participate in activities outside of the home); and
  • One of the following additional criteria is met:
    1. The individual is refractory or could not tolerate a minimum of 12 consecutive months of pharmacotherapy; or
    2. Intermittent catheterizations have failed or are not well tolerated after a trial of 12 consecutive months.
• A permanent sacral nerve stimulator is considered medically necessary for those with refractory urge incontinence, urge/frequency incontinence or non-obstructive urinary retention who have had a successful trial of the temporary sacral nerve stimulator and are an appropriate surgical candidate for permanent implantation. Successful trial is defined as:
  • Urinary retention: At least a 50% reduction in catheter volume/catheterization;
  • 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;
  • Urinary urge/frequency: At least 50% reduction in one of the following: number of voids daily, volume per void and frequency per void. 

Investigational and Not Medically Necessary:

• Sacral nerve stimulator therapy is considered investigational and not medically necessary for indications other than the medically necessary indications listed above, including but not limited to, the following:
  • Urge incontinence due to a neurologic condition (e.g., detrusor hyperreflexia);
  • Stress incontinence and other types of chronic voiding dysfunction due to neurologic conditions (e.g., spinal cord injury, diabetic neuropathy, multiple sclerosis);
  • Chronic pelvic pain. 

Sacral nerve stimulation: Fecal Incontinence 

Medically Necessary:

• Placement of a temporary sacral nerve stimulator is considered medically necessary for the treatment of fecal incontinence when all of the following criteria are met:
  • Incontinent episodes averaging greater than or equal to 2 per week for 6 consecutive months or for 12 consecutive months after vaginal childbirth; and
  • The medical record shows failure of or intolerance to conventional therapy (e.g., dietary modification, the addition of bulking and pharmacologic treatment); and
  • The individual is an appropriate surgical candidate.
• A permanent sacral nerve stimulator is considered medically necessary for the treatment of fecal incontinence when the individual had a successful trial of the temporary sacral nerve stimulator and is an appropriate surgical candidate for permanent implantation. Successful trial is defined as:
  • The individual has met the criteria above for evaluation for a temporary sacral nerve stimulator; and
  • Temporary sacral nerve stimulation shows at least a 50% improvement in symptoms.

Investigational and Not Medically Necessary:

• Sacral nerve stimulation is considered investigational and not medically necessary for fecal incontinence that may be related to:
  • Rectal surgery for conditions other than cancer, performed within the past 12 months; or
  • Rectal surgery for cancer performed within the past 24 months; or
  • Anorectal malformation (e.g., congenital anorectal malformation); or 
  • Visible sequelae of pelvic radiation; or
  • Active anal abscesses and fistulae; or
  • Chronic inflammatory bowel disease (IBD); or
  • Peripheral neuropathy; or
  • Complete spinal cord injury (no motor or sensory function the sacral segments S4-S5); or
  • Constipation.

Percutaneous tibial nerve stimulation (PTNS)

Investigational and Not Medically Necessary:

• PTNS is considered investigational and not medically necessary for:
  • All indications dealing with urinary dysfunction, including but not limited to, treatment of overactive bladder symptoms such as urinary urgency, urinary frequency and urge incontinence, stress incontinence, non-obstructive urinary retention and interstitial cystitis;
  • All indications dealing with fecal dysfunction such as incontinence, constipation, IBD, anal sphincter dysfunction.

Sacral Nerve Stimulation (Interstim^® Medtronic Inc., Minneapolis, MN)

The Interstim device was investigated in a large multicenter, randomized clinical trial that demonstrated that the device was effective in significantly reducing urinary symptoms in those with urge incontinence, urgency frequency and non-obstructive urinary retention (Schmidt, 1999; Hassouna, 2000). It was approved by the Food and Drug Administration (FDA) in 1998 for urinary incontinence and received additional labeled approval for urinary retention in 1999.  

Brazzelli and colleagues (2006) conducted a systematic review for the efficacy and safety of SNS for urge incontinence. Four randomized controlled trials and 30 case series were identified. The randomized controlled trials, involved approximately 120 subjects, showed that about 80% achieved continence or greater than 50% improvement in their main incontinence symptoms after SNS compared with about 3% of controls receiving conservative treatments while waiting for an implant. While case series were larger, they were methodologically less reliable. The case series showed similar results with 67% of individuals becoming dry or achieving a greater than 50% improvement in symptoms after implantation. Increased urine continence was reported to last 3 to 5 years after implantation. The studies were not without adverse events, which were documented in 27 studies. The common complications were pain at the implant or lead site in 25% of individuals, lead related problems such as lead migration in 16%, replacement and repositioning of the implanted pulse generator in 15%, and wound problems in 7%. Nine percent of the participants required removal of the electrodes. The authors concluded that the evidence supports the efficacy of the SNS device for decreasing incontinence. Device revisions have been shown to reduce the adverse effects.

Herbison and colleague (2009) reported on 8 randomized studies that evaluated implants which provided continuous stimulation. Although there were some methodological problems with the studies and apparent adverse events, after review, the authors concluded 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 also advocated that the effectiveness of implants should be tested against other interventions, particularly in people with an overactive bladder.

In the past, SNS for FI has been reported in small case series suggesting potential benefit from this therapy (Ganio, 2001; Kenefick, 2002; Rosen, 2001). 

The Food and Drug Administration (FDA) approved the Interstim device for the application of FI on March 14, 2011, subject to a 5 year post approval study. The post-approval study will be called the InterStim Sacral Nerve Stimulation Therapy for Bowel Control: Fecal Incontinence Post Approval Study (FI-PAS). The primary objective is to continue evaluation of incontinent episodes per week at yearly intervals through five years post-implant. Both device and therapy adverse events will be tracked during this time period.

Leroi and colleagues (2005) addressed SNS treatment of FI for a possible placebo effect in a randomized, double blind, crossover study. Thirty-four participants underwent sacral nerve stimulation for fecal incontinence. After implantation, 27 of the 34 participants were randomized in a double-blind crossover design to stimulation ON or OFF for 1-month periods. While still blinded, the participants chose the period of stimulation (ON or OFF) that they had preferred. The mode of stimulation corresponding to the selected period was continued for 3 months (final period). Outcome measures were frequency of fecal incontinence and urgency episodes, delay in postponing defecation, score severity, feeling of improvement, preference for ON or OFF, quality of life, and manometric measurements. Twenty-four participants completed the 3 month study. The results showed that the frequency of fecal incontinence episodes was significantly reduced during the ON versus the OFF period. In the final period of the study, the frequency of fecal incontinence episodes decreased significantly in those with the stimulator ON. The ability to postpone defecation, the score for symptom severity, and the quality of life as well as anal sphincter function significantly improved. The results of this study indicate that the clinical benefit of sacral nerve stimulation was not due to placebo.

Tjandra and colleagues (2008) studied SNS for FI in 53 individuals randomized to SNS and 60 individuals randomized to the best supportive therapy, consisting of pelvic floor exercises with biofeedback, bulking agents, and dietary management. 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 1 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 group (42%) and 13 (24%) improved by 75% to 99%.

Matzel and colleagues (2008) reported long-term outcomes on 9 individuals who were treated with SNS implantation for severe FI between 1994 and 1999. Continued efficacy averaged 10 years (range 7-14 years). Complete continence was achieved in 5 participants and 3 had less than 10% incontinent episodes. Complications occurred in 5 of the original 12 and were therapy-related. After 7 years, device battery life was exhausted in 8 participants and required replacement. 

Wexner and colleagues (2010) reported results from a prospective, multicenter study of SNS for FI. Inclusion criteria were refractory fecal incontinence averaging 2 episodes per week for 6 months or for 12 months after vaginal delivery. Excluded were those who had previous rectal surgery, if performed within the last 12 months (or within 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. Out of 285 participants evaluated, 120 participants underwent preliminary test stimulation procedures and showed a greater than or equal to 50% improvement. This group went on to receive a permanent stimulator. A 50% or better improvement was seen in 106 participants at 12 months, 67 participants at 24 months and 30 participants at 36 months, based on records of incontinent episodes. Further analysis showed that 40% of the 106 participants at the 12 month follow-up reported complete continence.

While the literature supports SNS for FI, the adverse event occurrence is high. Additionally, degree of success varies among the eligible population. Careful selection of individuals for this treatment is extremely important (Mowat, 2008). Information regarding the benefits and risks should be discussed so that suitable individuals can make an informed decision. 

There is inadequate data supporting the use of the Interstim device for chronic pelvic pain or neurologic disorders, such as multiple sclerosis or spinal cord injury. 

Percutaneous Tibial Nerve Stimulation (Urgent ^® PC Neuromodulation System Uroplasty, Inc., Minnetonka, MN)

The Urgent PC device received FDA 510k clearance on August 20, 2007 for treatment of those with urinary urgency, urinary frequency, and urge incontinence.

Peters and colleagues (2010) identified a scientific and clinical need to test PTNS in a controlled clinical trial since most drug or device studies investigating voiding dysfunction have a large placebo effect. They conducted a randomized, blinded control study testing a proposed realistic sham against PTNS on 30 healthy subjects. The participants were blinded when given PTNS stimulation and TENS stimulation (sham). The TENS stimulation was modified to mimic PTNS. In total, 10/30 (33%) of the shams were identified correctly. From this study the authors concluded that subjects are unable to identify whether they are receiving a sham or the PTNS and that this protocol provides a reasonable sham for PTNS controlled studies.

Peters and colleagues (2009) also conducted an industry supported, unblinded, randomized trial comparing PTNS and extended-release tolterodine (Detrol LA) in women with overactive bladder syndrome. Subjects had to have symptoms of overactive bladder (OAB) with at least 8 voids per 24 hours; the mean daily voids for those entering the study were 12.3. The primary outcome was the non-inferiority of PTNS in the mean reduction in the number of voids per 24 hours after 12 weeks of treatment. Study findings showed non-inferiority of PTNS based on results for 84 participants. The decrease in voids per day was 2.4 in the PTNS group and 2.5 in the tolterodine group. There was a statistically significant difference in the proportion of those reporting improvement or cure in symptoms (79.5 vs. 54.8%). Limitations of this study include the lack of blinding of participants and providers as well as lack of a sham/placebo group both to mitigate the potential bias due to subjective outcomes and to evaluate whether either treatment is better than placebo. Another limitation is that it reports on short-term efficacy only.

In 2010, MacDiarmid and colleagues reported on those with successful PTNS (responders) who were studied for 12 weeks in a previous study (Peters, 2009). Thirty-three PTNS responders continued therapy with 32 and 25 subjects completing 6 and 12 months of therapy, respectively. One participant withdrew prior to the 6 month evaluation. Subjects received a mean of 12.1 treatments during an average of 263 days, with a mean of 21 days (median 17) between treatments. Subject global response assessments showed sustained improvement from 12 weeks at 6 and 12 months, with 94% and 96% of responders, respectively. OAB symptom improvements including frequency, nocturia, urgency, voided volume and urge incontinence episodes were sustained for all outcomes from 12 weeks through 6 and 12 months. At 6 and 12 months all voiding diary (6 months n=30; 12 months n=25) parameters showed statistically significant improvements in mean values compared to baseline. Although the study showed significant improvements in continence, its small size is a drawback. The authors reported that 1 subject withdrew prior to the 6 month assessment and those who withdrew after the 6 month interval (n=7), were considered improved at the last assessment evaluation.  Using Last-Observation-Carried-Forward (LOCF) can introduce a biased estimate of the treatment effect.  

In another study, Peters and colleagues (2010) described a multicenter, double blinded, randomized controlled trial evaluating the efficacy of PTNS to inactive sham therapy in participants with overactive bladder (OAB) symptoms. Two hundred twenty participants were randomized in a 1:1 ratio, one group (n=110) receiving PTNS and the other group (n=110) receiving sham treatment for 30 minutes, once a week, for 12 weeks. OAB quality of life questionnaires and 3-day voiding diaries began at baseline and were completed at week 13. Global response assessments were also compiled at week 13. Results showed a significant improvement in bladder symptoms in the PTNS group (54.4%) vs. the sham group (20.9%) from baseline (p ≤ 0.001). Individual voiding diaries also showed statistically significant improvements in urinary frequency, nighttime voiding, urgency and incontinent episodes. Adverse events such as ankle bruising, bleeding and needle site discomfort only occurred in the PTNS group. No adverse effects occurred in the sham group. While the study demonstrated improvements using PTNS, its limitation was the short term follow-up. Further, the authors only described the participant blinding in this double blinded study. 

PTNS has also been proposed for treatment of FI. The published literature consists of small observational studies quantified by measurements of FI episodes, ability to defer defecation, quality of life improvement and treatment success up to 14 months.

Govaert and colleagues (2010) studied PTNS in 22 individuals with FI. Follow-up at 6 weeks showed that 13 participants had a greater than 50% decrease in incontinence episodes. Overall incontinence episodes fell from 19.6 plus or minus 21.0 at baseline to 9.9 plus or minus 15.5 (p = 0.082) at 6 weeks and to 3.6 plus or minus 4.8 (p = 0.029) at 1 year.

In a prospective study over 14 months (median 9 months), Boyle and colleagues (2010) reported outcomes for PTNS therapy in 31 subjects with urge FI. Twenty-one (68%) participants improved following percutaneous tibial nerve stimulation and remain satisfied with the clinical response.  Median fecal incontinence episodes per week declined from 4 (range, 0-30) to 0 (range, 0-27) (p ≤ .0001). The authors concluded that this preliminary study demonstrated that percutaneous tibial nerve stimulation is an effective and very well tolerated treatment for individuals with urge fecal incontinence with particular improvement in reducing fecal urgency.

Other studies (Eléouet, 2010; Findlay, 2010) had similar results however, while PTNS is a promising treatment, larger, randomized controlled trials are needed to demonstrate efficacy for the treatment of FI.

A sacral nerve stimulator (Interstim) is a device that is surgically implanted (different from pelvic floor stimulation) to treat urinary or fecal incontinence. A percutaneous nerve evaluation is performed to confirm the integrity of the peripheral nerves and feasibility of stimulation, identify the optimal site for a temporary stimulation trial and allow for the actual temporary stimulation test to determine their response and whether they are a candidate for the permanent device. A temporary sacral nerve stimulator is implanted 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 a portable external stimulator, carried in the pocket or attached to a belt. The individual can 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. Implantation of the permanent device is done under general anesthesia. The rate of adverse events is high: about 20% experienced an event during peripheral nerve evaluation testing, and 50% experienced one or more events following implantation. Most of these are minor, and resolve with treatment, or device revision. Adverse effects include post-implant pain, infection, adverse changes in bowel function, lead migration, and electric shock sensation.

Percutaneous tibial nerve stimulation (Urgent PC) involves a battery powered external electrical pulse generator and a needle electrode lead set. The needle probe is implanted in the tibial nerve and is attached to the electrical pulse generator. This minimally invasive neuromodulation system was developed as a less-invasive alternative to sacral nerve stimulation. It is designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. 

PTNS treatment includes a 12-week initial treatment phase followed by an indefinite maintenance treatment phase, with each of these phases having different treatment protocols. The initial treatment phase consists of 1 to 3 weekly 30-minute treatment sessions for 12 weeks.

Neuromodulation: Stimulation of a nerve.

Sacral nerve: Any of five pairs of spinal nerves in the sacral region which innervate muscles and skin of the lower back, lower extremities, and perineum, and branches to the hypogastric and pelvic plexuses.

Sacral nerve stimulation: A permanent implantable device that stimulates the neural pathways controlling bladder function.

Stress urinary incontinence (SUI): The leakage of urine during physical activities that increase pressure on the bladder.

Sphincter: A ring-like band of muscle fibers that constrict a passage or close a natural opening.

Tibial nerve: The medial terminal branch of the sciatic nerve. The tibial nerve fibers originate in lumbar and sacral spinal segments (L4 to S2). They supply motor and sensory innervation to parts of the calf and foot.

Urethra: The natural channel or tube through which urine passes from the bladder to outside of the body.

Urinary retention: The inability to completely empty the bladder of urine.

Urinary urge incontinence: Leakage of urine when there is a strong urge to void.

Urinary urgency-frequency: An uncontrollable urge to urinate resulting in very frequent, small volumes.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Investigational and Not Medically Necessary:
For the codes listed above when criteria are not met or for the following diagnoses, or when the code describes a procedure indicated in the Position Statement section as Investigational and Not Medically Necessary.

When services are also Investigational and Not Medically Necessary:
For the following procedure code for the diagnoses listed, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Future ICD-10 coding (effective 10/01/2013) 
A draft of ICD-10 Coding related to this document, as it might look today, is available for reference and comments at: Appendix 1: Future ICD-10 coding

Peer Reviewed Publications:

1. Boyle DJ, Prosser K, Allison ME, et al.  Percutaneous tibial nerve stimulation for the treatment of urge fecal incontinence. Dis Colon Rectum. 2010; 53(4):432-437.
2. Brazzelli M, Murray A, Fraser C. Efficacy and safety of sacral nerve stimulation for urinary urge incontinence: a systematic review. J Urol. 2006; 175(3 Pt 1):835-841.
3. Eléouet M, Siproudhis L, Guillou N, et al. Chronic posterior tibial nerve transcutaneous electrical nerve stimulation (TENS) to treat fecal incontinence (FI). Int J Colorectal Dis. 2010; 25(9):1127-1132. 
4. Elkelini M, Hassouna MM. Canadian experience in sacral neuromodulation. Urol Clin North Am. 2005; 32(1):41-49.
5. Finazzi-Agro E, Petta F, Sciobica F, et al. Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: a randomized, double-blind, placebo controlled trial. J Urol. 2010;184(5):2001-2006
6. Findlay JM, Yeung JM, Robinson R, et al. Peripheral neuromodulation via posterior tibial nerve stimulation - a potential treatment for faecal incontinence? Ann R Coll Surg Engl. 2010; 92(5):385-390.
7. Govaert B, Pares D, Delgado-Aros S, et al. A prospective multicentre study to investigate percutaneous tibial nerve stimulation for the treatment of faecal incontinence. Colorectal Dis. 2010; 12(12):1236-1241.
8. Hassouna MM, Siegel SW, Nyeholt AA, et al. Sacral neuromodulation in the treatment of urgency-frequency symptoms: a multicenter study on efficacy and safety. J Urol. 2000; 163(6):1849-1854.
9. Janknegt RA, Hassouna MM, Siegel SW, et al. Long-term effectiveness of sacral nerve stimulation for refractory urge incontinence. Eur Urol. 2001; 39(1):101-106.
10. Jonas U, Fowler CJ, Chancellor MB, et al. Efficacy of sacral nerve stimulation for urinary retention: results 18 months after implantation. J Urol. 2001; 165(1):15-19.
11. MacDiarmid SA, Peters KM, Shobeiri SA, et al. Long-term durability of percutaneous tibial nerve stimulation for the treatment of overactive bladder. J Urol. 2010; 183(1):234-240.
12. Michelsen HB, Thompson-Fawcett M, Lundby L, et al. Six years of experience with sacral nerve stimulation for fecal incontinence. Dis Colon Rectum 2010; 53(4):414-421.
13. Peters K, Carrico D, Burks F. Validation of a sham for percutaneous tibial nerve stimulation (PTNS). Neurourol Urodyn 2009; 28(1): 58-61.
14. Peters K, MacDiarmid SA, Wooldridge LS et al. Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. J Urol 2009; 182(3):1055-1061.
15. Peters KM, Carrico DJ, Perez-Marrero RA, et al. Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010; 183(4):1438-1443.
16. Schmidt RA, Jonas U, Oleson KA, et al. Sacral nerve stimulation for the treatment of refractory urinary urge incontinence. J Urol. 1999; 162(2):352-357.
17. Tjandra JJ, Chan MK, Yeh CH, 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.
18. Van Balken MR, Vandoninck V, Gisolf KW, et al. Posterior tibial nerve stimulation as neuromodulative treatment of lower urinary tract dysfunction. U Urol. 2001; 166(3):914-918.
19. Van Balken MR, Vergunst H, Bemelmans BL. Prognostic factors for successful percutaneous tibial nerve stimulation. Eur Urol. 2006; 49(2):360-365.
20. Van Balken MR. Percutaneous tibial nerve stimulation: the Urgent PC^® device. Expert Rev Med Devices. 2007; 4(5):693-698.
21. Van der Pal F, van Balken MR, Heesakkers JP, et al. Correlation between quality of life and voiding variables in patients treated with percutaneous tibial nerve stimulation. BJU Int. 2006; 97(1):113-116.
22. Van der Pal F, van Balken MR, Heesakkers JP, et al. Percutaneous tibial nerve stimulation in the treatment of refractory overactive bladder syndrome: is maintenance treatment necessary? BJU Int. 2006; 97(3):547-550.
23. Vandoninck V, van Balken MR, Finazzi AE, et al. Posterior tibial nerve stimulation in the treatment of voiding dysfunction: urodynamic data. Neurourol Urodyn. 2004; 23(3):246-251. 
24. Vitton V, Damon H, Roman S, Mion F. Transcutaneous electrical posterior tibial nerve stimulation for faecal incontinence: effects on symptoms and quality of life. Int J Colorectal Dis. 2010; 25(8):1017-1020. 
25. Vitton V, Damon H, Roman S, Nancey S, et al. Transcutaneous posterior tibial nerve stimulation for fecal incontinence in inflammatory bowel disease patients: a therapeutic option? Inflamm Bowel Dis. 2009; 15(3):402-405.
26. Wexner SD, Coller JA, Devroede G, et al. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. 2010; 251(3):441-449.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Agency for Healthcare Research and Quality (AHRQ). National Guideline Clearinghouse (NGC). Guideline synthesis: Assessment and management of urinary incontinence in women. 2010. Available at:  http://www.guideline.gov/syntheses/synthesis.aspx?id=16411&search=urinary+incontinence.  Accessed on June 23, 2011.
2. American College of Obstetricians and Gynecologists (ACOG). Urinary incontinence in women. ACOG practice bulletin number 63. 2005. Available at: http://www.guideline.gov/summary/summary.aspx?doc_id=10931&nbr=5711&ss=6&xl=999 . Accessed on June 23, 2011.
3. American Society of Colon and Rectal Surgeons. Practice Parameters for the Treatment of Fecal Incontinence. Dis Colon Rectum 2007; 50: 1497–1507.
4. Blue Cross and Blue Shield Association. Sacral Nerve Stimulation for the Treatment of Urinary Urgency/Frequency in Adults. TEC Assessment, 2000; 15(7).
5. Blue Cross and Blue Shield Association. Percutaneous tibial nerve stimulation for the treatment of voiding dysfunction. TEC Assessments 2010; Volume 25, Tab TBD.
6. Centers for Medicare and Medicaid Services. National Coverage Determination for Bladder Stimulators (Pacemakers). NCD #230.16. Effective October 7, 1996. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=243&ncdver=1&bc=AgAAQAAAAAAA& . Accessed on June 23, 2011.
7. Centers for Medicare and Medicaid Services. National Coverage Determination for Incontinence Control Devices. NCD #230.10. Effective October 7, 1996. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=241&ncdver=1&bc=AgAAQAAAAAAA&. Accessed on June 23, 2011.
8. Centers for Medicare and Medicaid Services. National Coverage Determination for Sacral Nerve Stimulation for Urinary Incontinence. NCD #230.18. Effective January 1, 2002. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=249&ncdver=1&bc=AgAAQAAAAAAA& . Accessed on June 23, 2011.
9. Herbison GP, Arnold EP. Sacral neuromodulation with implanted devices for urinary storage and voiding dysfunction in adults. Cochrane Database Syst Rev 2009; (2):CD004202.
10. Mowatt G, Glazener C, Jarrett M. Sacral nerve stimulation for faecal incontinence and constipation in adults. Cochrane Database Syst Rev. 2007; (3):CD004464.
11. U.S. Food and Drug Administration (FDA) Premarket Approval. Interstim Sacral Nerve Stimulation System (Urinary). Summary of Safety and Effectiveness. No. P970004. Rockville, MD: FDA. October 21, 1998. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P970004S004. Accessed on June 7, 2011.
12. U.S. Food and Drug Administration (FDA) Premarket Approval. Interstim Sacral Nerve Stimulation System (Fecal). Summary of Safety and Effectiveness. No. P080025. Rockville, MD: FDA. March 14, 2011 Available at:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p080025. Accessed on June 7, 2011.
13. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Urgent^® PC Neuromodulation System 510(K) Summary. No. K071822 Rockville, MD: FDA. August 29, 2000. Available at  http://www.accessdata.fda.gov/cdrh_docs/pdf7/K071822.pdf. Accessed on June 7, 2011.

1. National Institutes of Health (NIH). National Kidney and Urologic Diseases Information Clearinghouse. Urinary Incontinence in Women. Available at: http://kidney.niddk.nih.gov/kudiseases/pubs/uiwomen/index.htm. Accessed on June 23, 2011.
2. National Institutes of Health (NIH). National Digestive Diseases Information Clearinghouse. Fecal Incontinence. Available at: http://digestive.niddk.nih.gov/ddiseases/pubs/fecalincontinence/.  Accessed on June 23, 2011.

Interstim
Percutaneous Tibial Nerve Stimulation (PTNS)
Urgent PC Neuromodulation System
Sacral Nerve Stimulation for Urinary Incontinence

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.