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Sacral Neuromodulation

  • Education and Training
  • Efficacy
  • Products and Procedures
  • Reimbursement and Practice Management
  • Indications, Safety, and Warnings
  • Patient Selection

    There are many factors crucial to the success of Sacral Neuromodulation, delivered by the InterStim® System. One of the most important is patient selection.

    Candidates

    Sacral Neuromodulation, delivered by the Interstim® System, is indicated for patients who have failed or could not tolerate more conservative treatments for one or more of the following conditions:

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

    Bladder Control Candidates

    A broad range of patients with overactive bladder and non-obstructive urinary retention are considered suitable for Sacral Neuromodulation once they have failed or could not tolerate more conservative treatments.

    Sacral Neuromodulation is most appropriate for patients who:

    • Suffer from quality of life issues
    • Experience urge incontinence or urgency-frequency
    • Experience urinary retention without an obstruction
    • Desire an alternative to medication due to side-effects or lack of efficacy 

    Sacral Neuromodulation is not appropriate for patients who:

    • Have not demonstrated an appropriate response to the evaluation (screening test) 
    • Experience primarily stress incontinence
    • Are unable to operate the neuromodulation system
    • Are not appropriate candidates for surgery
    • Experience urinary retention due to mechanical obstructions such as benign prostatic hypertrophy, cancer, or urethral stricture

    Safety and effectiveness of the InterStim System have not been established for:

    • Bilateral stimulation
    • Pregnancy, unborn fetus, and delivery
    • Pediatric use under the age of 16
    • Or for patients with neurological disease origins such as multiple sclerosis or diabetes 

    Bowel Control Candidates

    A broad range of chronic fecal incontinent patients are considered suitable for Sacral Neuromodulation, delivered by the InterStim System if they have failed or are not candidates for more conservative treatments such as medication, behavior modifications, bowel retraining, and/or pelvic muscle strengthening.

    Sacral Neuromodulation is most appropriate for patients who:

    • Suffer from quality of life issues
    • Experience chronic fecal incontinence

    Sacral Neuromodulation is not appropriate for patients who:

    • Have not demonstrated an appropriate response to the evaluation
    • Are unable to operate the neuromodulation system
    • Are not appropriate candidates for surgery

    Safety and effectiveness of the InterStim System have not been established for:

    • Bilateral stimulation
    • Pregnancy, unborn fetus, and delivery
    • Pediatric use under the age of 18
    • Patients with progressive, systemic neurologic diseases 

    Guidelines: OAB

    AUA OAB Guidelines

    After an extensive clinical evidence review, the AUA OAB Guidelines Panel has labeled Sacral Neuromodulation as a recommendation for refractory idiopathic OAB patients based on Level C evidence, because the clinical benefits outweigh the risks/burdens.

    Below is a summary of the AUA OAB guidelines. For detailed guidelines, refer to the OAB guidelines on the AUA website.


    OAB Diagnosis

    When assessing patients with OAB, there are 3 primary areas on which to focus:

    • Initial assessment/patient history
    • Physical exam
    • Urinalysis

    Treatment Options

    First Line Treatment
    Behavioral therapies are a first line treatment for overactive bladder (non-neurogenic) in adults:

    • Bladder training
    • Bladder control strategies
    • Pelvic floor muscle training
    • Fluid management

    Behavorial therapies may be combined with pharmacologic therapy.

    Second Line Treatment
    Anti-muscarinic and  β3-adrenoceptor agonist medications, including oral
    anti-muscarinics, transdermal (TDS) oxybutynin, and oral β3-adrenoceptor agonists are a second line treatment for overactive bladder (non-neurogenic) in adults. Use caution in prescribing anti-muscarinics in patients with:

    • Impaired gastric emptying
    • Narrow-angle glaucoma
    • History of urinary retention

    Patients are considered refractory after failing behavioral therapy of sufficient length and one anti-muscarinic administered for 4 to 8 weeks. Dose modification or a different anti-muscarinic may be tried for inadequate symptom control and/or adverse events.

    Third Line Treatment
    For refractory patients, who failed behavioral therapy of sufficient length and one anti-muscarinic administered for 4 to 8 weeks, the AUA guidelines labels the following therapies for carefully selected patients:

    • Sacral Neuromodulation
    • Percutaneous tibial nerve stimulation
    • Intradetrusor Onabotulinum toxin A

    OAB Treatment Algorithm

    Below is an example of a typical bladder control treatment pathway for a patient who is seeking treatment for symptoms of urge-incontinence and/or urgency-frequency.1, 2

    oab-path
    AUA OAB Algorithm

    This algorithm from the AUA maps out a diagnosis and treatment pathway for non-neurogenic overactive bladder in adults.

    References
    1. Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. The Journal of urology. Dec 2012;188(6 Suppl):2455-2463.
    2. Medtronic-sponsored research. InterStim Therapy Clinical Summary 2011.

    Urinary Retention Diagnosis

    When assessing patients with non-obstructive urinary retention to determine if they may benefit from Sacral Neuromodulation, there are 3 primary areas on which to focus:

    • Initial assessment/patient history
    • Physical exam
    • Urinalysis

    Patient remarks may also provide clues to identify those patients with symptoms of overactive bladder and urinary retention. The Patient Identification Tip Sheet provides examples of these comments.

    Prior to the first visit, it may be useful to have the patient complete the Bladder Symptom Tracker. This tool is a self-monitored, written record of how often and how much a patient urinates, the amount of leakage, the degree of urgency prior to voiding, and the sensation of an empty bladder after voiding.

    The symptom tracker may also be useful as baseline data for follow-up comparison once treatment has been initiated.

    Urinary Retention Treatment Algorithm

    Below is an example of a typical bladder control treatment pathway for a patient who is seeking treatment for symptoms of UR.1, 2

    ur-path5
    References
    1. Selius BA, Subedi R. Urinary retention in adults: diagnosis and initial management. American family physician. Mar 1 2008;77(5):643-650.
    2. Medtronic-sponsored research. InterStim Therapy Clinical Summary 2011

    Guidelines: Bowel Incontinence

    For patients who have failed or cannot tolerate more conservative treatments for chronic fecal incontinence, both ASCRS and ACG strongly recommend Sacral Neuromodulation. Below are clinical guidelines for the management of bowel incontinence.

    ACG Clinical Guideline: Management of Benign Anorectal Disorders

    ASCRS Clnical Practice Guideline for the Treatment of Fecal Incontinence


    Bowel Incontinence Diagnosis

    When assessing a patient with chronic fecal incontinence for Sacral Neuromodulation, there are 4 primary areas on which to focus:

    • Patient history
    • Bowel diary
    • Quality of Life questionnaire
    • Physical exam and diagnostic testing

    Symptom Tracker

    Prior to the first visit, it may be useful to have the patient keep a record of their bowel episodes by using a symptom tracker. This is a self-monitored, written record of the frequency of bowel episodes, the amount of incontinence experienced, urgency, stool description, and whether or not the episode happened while the patient was asleep. You can use the symptom tracker as a tool to identify a pattern of episodes which may assist in your diagnosis.


    Bowel Symptom Questionnaire

    The bowel symptom questionnaire can help identify patients who are dissatisfied with more conservative bowel control treatments.


    Treatment Options

    Effective treatments are available for bowel incontinence and can improve bowel control. The type of treatment depends on the cause and severity the condition, and more than one treatment may be necessary in some patients. Treatment options include:

    • Behavioral techniques, which include lifestyle changes, fluid and diet modification, bowel retraining, Kegel exercises and other kinds of physical therapy
    • Anti-diarrheal medications, which may help with developing a more regular bowel pattern or decreasing the water content of stool
    • Sacral Neuromodulation delivered by the Medtronic InterStim System
    • Major surgery, including sphincteroplasty, colostomy, sphincter replacement and operations to treat rectal prolapse, a rectocele or hemorrhoids

    Treatment Algorithms

    Below is an example of a typical bowel control treatment pathway for a patient who is seeking treatment for symptoms of chronic fecal incontinence.1

     

     

    References
    1. Abrams P, Andersson KE, et. al. Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and Treatment of Urinary Incontinence, Pelvic Organ Prolapse, and Fecal Incontinence. Neurology and Urodynamics. 29:231-240 (2010)

    Evaluation

    Sacral Neuromodulation is evaluated prior to implant of the InterStim System. During the evaluation, a lead is placed near the sacral nerves and connected to an external neurostimulator.

    The evaluation allows patients to try the therapy and assess not only its efficacy but also its tolerability and sensation so physicians and patients can make an educated decision whether or not to proceed with an InterStim System implant. In general, the evaluation is considered a success if the patient experiences 50% or greater reduction in his or her dysfunctional bladder control or bowel control symptoms.

    Peripheral Nerve Evaluation: Stacking Cases

    Hear Dr. Thomas Chun and Dr. Brian Raybon describe how to combine or stack peripheral nerve evaluation (PNE) cases into one dedicated procedure day as a way to make patient flow more efficient.

    Evaluation Techniques

    There are two evaluation techniques for Sacral Neuromodulation: the basic evaluation, and the advanced evaluation. Either technique can be used to test Sacral Neuromodulation for Bladder Control or Bowel Control. Both evaluations are short-term, and the effects are reversible by surgically removing the lead or turning off the device.

    With both evaluation techniques, a portable, external stimulator delivers the stimulation via an implanted lead; the patient wears this stimulator during the evaluation. Patients complete a symptom diary prior to the evaluation to establish a baseline measure of incontinence; and during the evaluation to measure improvement.

    The new Verify® Evaluation System can be used with the basic or advanced evaluation. This discreet and simple system can provide valuable insight to guide an informed decision about long-term therapy with the InterStim System.

    Basic Evaluation

    The basic evaluation, sometimes called peripheral nerve evaluation (PNE), uses a temporary lead that is removed when the evaluation ends. The lead is typically inserted in-office using a local anesthetic. The basic evaluation can be conducted for up to 7 days. If this evaluation is inconclusive or unsuccessful, then the advanced evaluation, which uses the tined lead, is recommended.

    Advanced Evaluation

    With the advanced evaluation, also referred to as a Stage 1 evaluation, a tined lead is implanted and used for the evaluation. The tines assist in anchoring the lead in place and the lead also contains four electrodes that provide additional stimulation programming options. The tined lead is placed during an outpatient procedure using monitored anesthesia (MAC) or general anesthesia. The advanced evaluation can be conducted up to 14 days. If the evaluation shows positive results, the lead can remain in place and the neurostimulator and lead extension (if applicable) can be implanted.

    View details about the evaluation procedure

    Complications can occur with the evaluation procedure, including movement of the wire, technical problems with the device, and some temporary pain.

    The InterStim System is implanted only if the physician and the patient have identified a significant reduction in the patient’s bladder control or bowel control symptoms as a result of the data gathered during the evaluation. For information on the implant procedure, refer to the InterStim and InterStim II Implant Manual.

     

    Evaluation Responses During Studies

    The evaluation identifies patients whose OAB, non-obstructive urinary retention, or chronic fecal incontinence symptoms may be improved by Sacral Neuromodulation, delivered by the InterStim System. As shown in the studies described below, some patients show a significant reduction in bladder control or bowel control symptoms during the evaluation.

    Urge Incontinence Study1

    One hundred eighty-four urge-incontinent patients were enrolled in the study (36 males). The mean age was 47 years (range 20 to 79 years). These 184 patients underwent at least one, and in some cases up to six evaluation procedures. Of these 184 screened patients, 112 had a successful evaluation result (experienced at least a 50% improvement in leaking variables). Of these 112 patients who were eligible for implantation, 100 (9 males) were implanted with the InterStim System. The most common adverse events during the evaluation phase included lead migration, technical problems with the device, and some temporary pain.


    Urgency-Frequency Study1

    Two-hundred twenty urgency-frequency patients were enrolled into the study (44 males). The mean age was 41 years (range 17 to 78 years). These 220 patients underwent one, and in some cases, up to six evaluation procedures. Of the 220 screened patients, 80 had a successful evaluation result (experienced at least a 50% reduction in urgency-frequency parameters). Of the 80 patients who were eligible for implantation, 64 (6 males) were implanted with the InterStim System. The most common adverse events during the evaluation phase included lead migration, technical problems with the device, and some temporary pain.


    Retention Study1

    One hundred seventy-seven retention patients were enrolled into the study (46 males). The mean age was 43 years (range 17 to 81 years). These 177 patients underwent one, and in some cases, up to five evaluation procedures. Of the 177 screened patients, 68 had a successful evaluation result (experienced at least a 50% reduction in residual volume). Of the 68 patients who were eligible for implantation, 55 (7 males) were implanted with the InterStim System. The most common adverse events during the evaluation phase included lead migration, technical problems with the device, and some temporary pain.


    Fecal Incontinence Study

    In clinical studies,1-3 up to 90% of patients who underwent the evaluation had a positive response and went on to receive the device implant. The studies defined a positive response as symptom reduction of at least 50%. The most common adverse events during the evaluation phase (n=132) included implant site pain, lead fracture, hematoma, lead migration/ dislodgement, pain in extremity, and skin irritation.2

    References
    1. Medtronic-sponsored research. InterStim Therapy Clinical Summary 2014.
    2. 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 Mar; 251(3):441-449.
    3. Tjandra JJ, Chan MKY, Yeh CH, Murray-Green C. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: a randomized, controlled study. Dis Colon Rectum. 2008 May;51(5):494-502.

     

    Tools and Resources

    Bladder Symptom Questionnaire - English
    Bladder Symptom Questionnaire - Spanish

    This questionnaire can help identify patients who are dissatisfied with more conservative OAB treatments.

    Bowel Symptom Questionnaire - English
    Bowel Symptom Questionnaire - Spanish

    This questionnaire can help identify patients who are dissatisfied with more conservative bowel control treatments.

    Bladder Symptom Tracker - English
    Bladder Symptom Tracker - Spanish

    This tool is a self-monitored, written record of how often and how much a patient urinates, the amount of leakage, the degree of urgency prior to voiding, and the sensation of an empty bladder after voiding. This symptom tracker may help assess patient complaints and correlate them with objective data. It may assist in differentiating those patients having high-frequency-high-volume voids from those having high-frequency/low-volume voids, consistent with OAB. The symptom tracker can also provide baseline data for follow-up comparison once treatment has been initiated.

    Bowel Symptom Tracker - English

    Patients can use this symptom tracker to record information about their bowel episodes, including frequency of bowel episodes, amount of incontinence experienced, urgency, stool description, and whether or not the episode happened while the patient was asleep. This information can help to identify a pattern of episodes which may assist in your diagnosis. The symptom tracker can also provide baseline data for follow-up comparison once treatment has been initiated.

    Patient Identification Tip Sheet - English
    Patient Identification Tip Sheet - Spanish

    Patient remarks may provide clues to identify those patients with symptoms of overactive bladder, urinary retention, or fecal incontinence. This tool provides examples of these remarks.

    Talking Points: Bladder Control

    Use these talking points to introduce Medtronic Bladder Control Therapy to your patients.

    Talking Points: Bowel Control

    Use these talking points to introduce Medtronic Bowel Control Therapy to your patients.

    InterStim Patient Therapy Guide

    This guide is designed to help patients understand how the InterStim System works and to answer questions they may have about the evaluation and long-term therapy. This guide is intended to be given to the patient prior to the evaluation.

    Patient Programming Manual for Test Stimulation

    This manual is designed to help patients understand how to use the controller for the Verify® Evaluation System.

    Verify Controller Quick Reference Guide for Patients

    This is a quick reference guide to help patients use the controller for the Verify Evaluation System.

    Verify Controller Clinician Programming Guide

    This manual includes instructions for using the controller model 3537 to program settings on the Verify external neurostimulator model 3531.

    Patient Management Guide – Verify Evaluation System for Sacral Neuromodulation

    This guide steps clinicians through the process of checking battery levels, replacing batteries, and re-establishing stimulation after replacing the ENS batteries. It also provides information about the "settings not available" notification.

    Test Stimulator Technical Manual

    This technical manual provides instructions for using the external neurostimulator.

     

    View all manuals and technical resources for Sacral Neuromodulation

    Studies

    The links below direct you to a website to view or purchase the abstract or full article.

    InterStim® Therapy: A Contemporary Approach to Overactive Bladder

    "To evaluate long-term patient satisfaction of sacral neuromodulation and to correlate satisfaction with incontinence parameters....Eighty-four percent of patients were satisfied with sacral neuromodulation at a mean of 27 months. An 84.5% reduction in 24-hr pad weight correlated with long-term patient satisfaction. In addition to lack of efficacy, device pain was a contributing factor to dissatisfaction."

    Kohli N, Patterson D. InterStim Therapy: A Contemporary Approach to Overactive Bladder. Rev Obstet Gynecol. 2009 Winter; 2(1): 18-27.

    Sacral Neuromodulation for Intractable Urge Incontinence: Are There Factors Associated with Cure?

    "This prospective analysis of patients with refractory urinary urge incontinence who underwent placement of a neuromodulator lead and generator was undertaken between October 2000 and December 2003. Quantitative assessment of the severity of their urinary leakage was assessed by preoperative and postoperative 3-day bladder diaries documenting leakage episodes, number of pads used per day, and a 24-hour pad weight assessment."

    Amundsen CL, Romero AA, Jamison MG, Webster GD. Sacral neuromodulation for intractable urge incontinence: are there factors associated with cure? Urology. 2005;66:746-750.

    The Total Economic Burden of Overactive Bladder in the United States: A Disease-Specific Approach

    "To employ results from a recent US population-based survey to calculate disease-specific total costs of overactive bladder (OAB)."

    Onukwugha E, Zuckerman I, et al. The Total Economic Burden of Overactive Bladder in the United States: A Disease-Specific Approach. Am J Manag Care. 2009 Mar; 15(4 Suppl):S90-7.

    The prevalence of lower urinary tract symptoms (LUTS) in the USA, the UK and Sweden: results from the Epidemiology of LUTS (EpiLUTS) study

    "To estimate and compare the prevalence and associated bother of lower urinary tract symptoms (LUTS) in the general populations of the USA, UK, and Sweden using current International Continence Society (ICS) definitions."

    Coyne KS, Sexton CC, et al. The prevalence of lower urinary tract symptoms (LUTS) in the USA, the UK and Sweden: results from the Epidemiology of LUTS (EpiLUTS) study. BJU Int. 2009 Aug;104(3):352-60

     

    United States