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Sacral Neuromodulation

  • Education and Training
  • Efficacy
  • Products and Procedures
  • Reimbursement and Practice Management
  • Indications, Safety, and Warnings
  • About Sacral Neuromodulation

    Medtronic Sacral Neuromodulation, delivered by the InterStim® System, offers long-term control of bladder control and bowel control symptoms through modulation of the nerves that help control the pelvic floor and lower urinary tract.

    Details

    Sacral Neuromodulation is a proven treatment option for bladder control and bowel control. More than 150,000 patients worldwide have received Sacral Neuromodulation for bladder control and bowel control.*

    Sacral Neuromodulation is delivered via the InterStim system. This implantable system sends electrical pulses to an area near the sacral nerve to modulate the neural activity that influences the behavior of the pelvic floor, lower urinary track, urinary and anal sphincters, and colon. Unlike oral medications that target the muscular component of bladder control, Sacral Neuromodulation offers control of symptoms through direct modulation of the nerve activity.1,2

    A distinct advantage of Sacral Neuromodulation is that it is tested for potential success prior to moving on to long-term therapy. The evaluation gives patients and physicians an opportunity to find out in as few as 3 to 7 days whether adequate symptom reduction is achieved.

    The most common adverse events experienced during clinical studies of patients with Sacral Neuromodulation included pain at implant sites, new pain, lead migration, infection, technical or device problems, adverse change in bowel or voiding function, and undesirable stimulation or sensations. Any of these may require additional surgery or cause return of symptoms. See Indications, Safety, and Warnings for additional safety information.

    Sacral Neuromodulation for Bladder Control

    Medtronic offers an innovative therapy for overactive bladder and urinary retention in patients who have failed or could not tolerate more conservative treatments. Sacral Neuromodulation provides bladder control therapy that addresses the nerve component of bladder control problems.3,4

    • FDA–approved in 1997 for urge incontinence, and in 1999 for urgency-frequency and urinary retention
    • Minimally invasive evaluation and implant procedure5,6
    • Proven efficacy – up to 5 years – in patients for whom more conventional therapy has been unsatisfactory7
    • In studies comparing patients who received Sacral Neuromodulation with patients who delayed implant and continued standard management, those with Sacral Neuromodulation experienced significant improvements in quality of life7

    In properly selected patients, Sacral Neuromodulation can dramatically reduce or eliminate symptoms of overactive bladder and urinary retention.3,4

    Sacral Neuromodulation for Bladder Control: Mechanism of Action**

    Medtronic Sacral Neuromodulation helps normalize neural activity between the bladder and the brain, enabling patients to experience improved urinary function. This video describes the theorized mechanism of action of the therapy.

    Sacral Neuromodulation for Bowel Control

    Sacral Neuromodulation is also proven effective for chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments. A Medtronic-sponsored, prospective, multicenter trial conducted under an FDA-approved investigational protocol with 120 implanted patients demonstrated a significant improvement in fecal incontinence symptoms and quality of life.7

    For the 106 implanted patients with complete follow-up diaries at 12 months: 7-8

    • 41% achieved complete continence
    • 83% achieved a 50% or greater reduction in incontinent episodes per week
    • Overall quality-of-life scores improved significantly from baseline, as measured by the four scales of the Fecal Incontinence Quality of Life instrument

    † Of the 120 implanted patients, 14 were missing some of their bowel diaries at follow up. If all 120 implanted patients are included and no improvement is assumed for those with missing diary information, 36% achieved complete continence and 73% achieved a 50% or greater reduction in the number of incontinent episodes per week, and overall quality-of-life scores improved significantly from baseline.

    Sacral Neuromodulation for Bowel Control: Mechanism of Action**

    The animations on this video demonstrate how nerve pathways affect bowel control and evacuation, and they show the theorized mechanism of action of Medtronic Sacral Neuromodulation for Bowel Control.

     

    * Data from InterStim Sales Analysis. Medtronic, Inc. October 2013.

    ** The animation presents the leading theory of the therapy’s mechanism of action based upon an extensive review of the scientific literature. Although other theories may exist, the efficacy of the Medtronic InterStim System in the treatment of approved indications has been proven in clinical studies.

    References
    1. Griebling TL. Neuromodulation: mechanisms of action. In: Kreder K, Dmochowski R, eds. The Overactive Bladder: Evaluation and Management. London, England: Informa UK Ltd; 2007:293-302.
    2. Leng WW, Chancellor MB. How sacral nerve stimulation neuromodulation works. Urol Clin N Am. 2005;32:11-18.
    3. Schmidt RA, Jonas U, Oleson KA, et al, for the Sacral Nerve Stimulation Study Group. Sacral nerve stimulation for treatment of refractory urinary urge incontinence. J Urol. 1999;162:352-357.
    4. Siegel SW, Catanzaro F, Dijkema HE, et al. Long-term results of a multicenter study on sacral nerve stimulation for treatment of urinary urge incontinence, urgency-frequency, and retention. Urology. 2000;56(suppl 6A):87-91.
    5. Spinelli M, Sievert KD. Latest technologic and surgical developments in using InterStim Therapy for sacral neuromodulation: impact on treatment success and safety. Eur Urol. Dec 2008;54(6):1287-1296.
    6. Spinelli M, Weil E, Ostardo E, et al. New Tined Lead Electrode in Sacral Neuromodulation: Experience from a Multicentre European Study. World Journal of Urology. 2005;23:225-229.
    7. Medtronic-sponsored Research. InterStim Therapy Clinical Summary 2011.
    8. Wexner SD, Coller JA, Devroede G, Hull T, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. 2010 Mar; 251(3):441-449.

       

    Indications and Contraindications

    Product technical manuals must be reviewed prior to use for detailed disclosure.

    Indications

    InterStim® Therapy for Urinary Control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.

    The following Warning applies only to InterStim Therapy for Urinary Control:

    Warning: This therapy is not intended for patients with mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture.

    InterStim Therapy for Bowel Control is indicated for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments.

    For both InterStim Therapy for Urinary Control and InterStim Therapy for Bowel Control: Select patients carefully to ensure that they meet the following criteria:

    • They are appropriate candidates for surgery
    • They can properly operate the system
    • They received satisfactory results from test stimulation

    Contraindications for Urinary Control and for Bowel Control

    Diathermy. Patients who have not demonstrated an appropriate response to test stimulation or are unable to operate the neurostimulator.

    Diagnosis and Treatment

    Patients who may benefit from Sacral Neuromodulation include those who have failed or could not benefit from more conservative treatments for one or more of the following conditions:

    • Overactive bladder (OAB)
      • Urge incontinence
      • Urgency-frequency
    • Non-obstructive urinary retention
    • Chronic fecal incontinence

    Both men and women are affected by these conditions.

    Prevalence of Overactive Bladder

    More than 37 million people in the United States – 1 in 6 adults – suffer from OAB.1,2

    Many symptomatic patients will not present to their provider for treatment3-5 because they see symptoms as a nuisance or as an embarrassment.6-8

    Instead of seeking help, many people with OAB adjust their habits and lifestyle to accommodate the management of symptoms and may adopt such coping mechanisms as restricting fluids and urinating to a timed schedule or at the first sensation of urgency.

    As noted in a recent study, of those women who did discuss OAB symptoms with a health care provider, more than half waited at least 1 year to request treatment. The study also found that many health care providers do not screen for OAB. Most women expressed dissatisfaction with currently available OAB treatments and their side effects.9

    Prevalence of Bowel Control Problems

    An estimated 18 million adults in the United States—about 1 in 12—suffer from FI.10

    New research shows that the majority (89%) of fecal incontinent patients are female, compared to male patients comprising 11%.11 The majority of fecal incontinent patients are an older female group, 50-plus years old with mixed etiology. 11

    Studies suggest that only a proportion of fecal incontinent patients, 15%-45% seek treatment.12-13

    Consider the following statistics that support the claim that fecal incontinence is a hidden condition:

    • For 84% of fecal incontinent patients, the physician was unaware of the patient's disorder13
    • 54% of respondents with fecal incontinence had not discussed the problem with a professional14
    • 65% of those with severe or major fecal incontinence which had an impact on the quality of life wanted help with their symptoms15

    Impact of Bladder Control and Bowel Control Problems on Quality of Life

    OAB and urinary retention should not be considered a normal part of life at any age, and they affect both men and women. Many people never report bladder control symptoms because they:

    • Are too embarrassed to seek treatment
    • Do not think their symptoms are bad enough to seek treatment
    • Believe their symptoms are normal consequences of aging and/or childbirth
    • Do not know there are effective treatments available

    Chronic fecal incontinence often causes profound emotional distress leading to social withdrawal and isolation.

    View InterStim Therapy for Bowel Control study data

    Candidates for Sacral Neuromodulation

    There are many factors crucial to the success of sacral neuromodulation. One of the most important is patient selection which includes:

    Treatment with Sacral Neuromodulation

    Sacral Neuromodulation, delivered by the InterStim System, is a proven treatment option for bladder control and bowel control. More than 125,000 patients worldwide have received Sacral Neuromodulation for Bladder Control and Bowel Control.*

    The InterStim System for Urinary Control and Bowel Control helps to control symptoms of overactive bladder, urinary retention symptoms, and chronic fecal incontinence through direct modulation of the nerve activity. The InterStim System sends electrical pulses to an area near the sacral nerve to influence the behavior of the pelvic floor, lower urinary tract, urinary and anal sphincters, and colon.

    Pelvic Floor
    In the pelvic floor, S3 is the most distal common point of innervations for the bladder and bowel. Sacral Neuromodulation targets S3.

    This therapy is not for everyone. Results vary; not every individual will receive the same benefits or experience the same complications. See indications, safety, and warnings.


    Sacral Neuromodulation for Bladder Control

    Not all patients benefit from standard medical therapy.16-17 Standard pharmacological therapy for OAB consists of administering anti-cholinergic medications, which mainly treat the efferent limb of the micturition reflect (muscular activity).

    While anti-cholinergic drug therapy may alleviate OAB symptoms for some patients, they are not effective for everyone. Furthermore, some of these medications may cause intolerable side effects for patients.

    While anticholinergic drugs address the muscle component in bladder control, sacral neuromodulation addresses the nerve component.17-18 Medtronic Sacral Neuromodulation is thought to help normalize neural activity from the bladder to the brain, enabling patients to experience improved urinary function.19-21

    Sacral Neuromodulation offers effective bladder control and proven efficacy in some patients for whom more conventional intervention has been unsatisfactory. The InterStim System sends electrical pulses to an area near the sacral nerve to help normalize neural activity from the bladder to the brain, enabling patients to experience improved urinary function.


    Sacral Neuromodulation for Bowel Control

    Not all patients benefit from conservative treatment options such as medication, diet modification, and exercise. Sacral Neuromodulation is a minimally invasive option that can restore bowel function.

    Sacral Neuromodulation for Bowel Control is effective, safe, and may offer patients improved quality of life.


    Key Components of the InterStim System

    Sacral Neuromodulation System

    Tined lead is placed parallel to the sacral nerve (targeting S3).
    Implantable neurostimulator generates mild electrical pulses that are delivered through the lead electrodes.
    Clinician and patient programmers are used to set the parameters of the electrical pulses.

    * Data from InterStim Sales Analysis. Medtronic, Inc. October 2012.

     

    References
    1. Stewart WF, Van Rooyen JB, Cundiff GW, et al. World J Urol. 2003;20(6):327-336.
    2. United Nations, Department of Economic and Social Affairs, Population Division (2011). World Population Prospects: The 2010 Revision, CD-ROM Edition.
    3. Hashim H, Abrams P. Overactive bladder: an update. Curr Opin Urol. 2007;17(4):231-236.
    4. Hu TW, Wagner TH, Bentkover JD, Leblanc K, Zhou SZ, Hunt T. Costs of urinary incontinence and overactive bladder in the United States: a comparative study. Urology. 2004;63(3):461-465.
    5. Ricci JA, Baggish JS, Hunt TL, et al. Coping strategies and health care-seeking behavior in a US national sample of adults with symptoms suggestive of overactive bladder. Clin Ther. 2001;23(8):1245-1259.
    6. Erdem N, Chu FM. Management of overactive bladder and urge urinary incontinence in the elderly patient. Am J Med. 2006;119(3 suppl 1):29-36.
    7. Hu TW, Wagner TG. Economic considerations in overactive bladder. Am J Manag Care. 2000;6(11 suppl):S591-S598.
    8. Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001;87(9):760-766.
    9. Dmochowski RR, Newman DK. Impact of overactive bladder on women in the United States: results of a national survey. Curr Med Res Opin. 2007;23:65-76.
    10. Whitehead WE, Borrud L, Goode PS, et al. Fecal incontinence in US adults: epidemiology and risk factors. Gastroenterology. Aug 2009;137(2):512-517.
    11. Medtronic Market Research, 2009.
    12. Bano F, Barrington JW. Prevalence of anorectal dysfunction in women attending health care services. Int Urogynecol J Pelvic Floor Dysfunct. Jan 2007;18(1):57-60.
    13. Damon H., et al. Prevalence of Anal Incontinence in Adults and Impact on Quality-of-Life. Gastroenterol Clin Biol. 2006 Jan;30(1):37-43.
    14. Edwards NI, Jones D. The prevalence of faecal incontinence in older people living at home. Age Ageing. Nov 2001;30(6):503-507.
    15. Perry S., et al. Prevalence of Faecal Incontinence in Adults Aged 40 Years or More Living in the Community. Gut. 2002 Apr;50(4):480-4.
    16. Schmidt RA, Jonas U, Oleson KA, et al, for the Sacral Nerve Stimulation Study Group. Sacral nerve stimulation for treatment of refractory urinary urge incontinence. J Urol. 1999;162:352-357.
    17. Siegel SW, Catanzaro F, Dijkema HE, et al. Long-term results of a multicenter study on sacral nerve stimulation for treatment of urinary urge incontenence, urgency-frequency, and retention. Urology. 2000;56(suppl61):87-91.
    18. Hashim H, Abrams P. Drug treatment of overactive bladder: efficacy, cost and quality-of-life considerations. Drugs. 2004;64:1643-1656.
    19. Johnson M. Transcutaneous electrical nerve stimulation (TENS). Published online Oct 15, 2012.
    20. Chancellor MB, Chartier-Kastler EJ. Neuromodulation. 2000;3(1):16-26.
    21. Leng WW, Chancellor MB. Urol Clin N Am. 2005;32:11-18.

    United States