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Sacral Neuromodulation

  • Education and Training
  • Efficacy
  • Products and Procedures
  • Reimbursement and Practice Management
  • Indications, Safety, and Warnings
  • Data and Clinical Outcomes

    Clinical Efficacy for Bladder Control

    Medtronic prospective, retrospective, and post-approval studies demonstrate that Sacral Neuromodulation for Bladder Control (delivered by the InterStim® System) is safe and effective.1,3

    The studies demonstrate that Sacral Neuromodulation effectively helps patients who have failed or could not tolerate conservative treatments for urge incontinence, urgency-frequency, or urinary retention.

    Superior Efficacy vs. Medications1

    Sacral Neuromodulation for Bladder Control outperforms medications, as shown in a six-month randomized study comparing Sacral Neuromodulation (SNM) to standard medical therapy (SMT) in patients with mild symptoms of OAB.1

    6-mo-chart1

    Numbers reflect as treated results, defined as subjects with diary data at baseline and 6 months (p=0.002). Intent to treat results, which include all randomized subjects, are 61% for SNM and 42% for SMT (p=0.02).

    Device-related adverse events occurred in 31% of SNM patients, and medication-related adverse events occurred in 27% of SMT patients. No unanticipated adverse events were reported. No serious device- or medication-related adverse events were reported.

    Greater Quality of Life compared to Medications1

    Sacral Neuromodulation for Bladder Control outperforms medications, as shown in a six-month randomized study comparing Sacral Neuromodulation (SNM) to standard medical therapy (SMT) in patients with mild symptoms of OAB.1

    6-mo-chart2

    SNM showed 3 times greater improvement in HRQOL total quality of life over 6 months.*

    *P<0.001. Improvements represent mean change compared with baseline.

    Device-related adverse events occurred in 31% of SNM patients, and medication-related adverse events occurred in 27% of SMT patients. No unanticipated adverse events were reported in SNM patients. No serious device- or medication-related adverse events were reported.

    12-Month Clinical Success3

    Following are data from the 12-month, non-randomized, multicenter study showing efficacy of Sacral Neuromodulation for patients with urge incontinence, urgency-frequency, and retention.

    12-mo-chart
    79% of patients with urge incontinence achieved clinical success
    • 45% remained completely dry

    • An additional 34% experienced ≥50% reduction in leaking

    64% of patients with urgency-frequency achieved clinical success

    • 31% returned to normal voids (4 to 7 voids/day)

    • An additional 33% experienced ≥50% reduction in number of voids/day

    77% of patients with urinary retention achieved clinical success

    • 61% eliminated use of catheters

    • An additional 16% experienced ≥50% reduction in catheterized urine volume


    In the same clinical study, patients receiving Sacral Neuromodulation demonstrated significantly improved quality of life at 6 months. These self-reported measures included physical health status, physical functioning, physical and emotional role, pain, and mental health.3

    Refer to the InterStim Therapy Clinical Summary 2011 for detailed information regarding the study results.

    Adverse Events
    The most common adverse events experienced during clinical studies 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.

    For additional safety information, please refer to Indications, Safety, and Warnings.

    5-Year Study Shows Sustained Efficacy3

    Following are data from the 5-year, non-randomized, multicenter study showing sustained efficacy of Sacral Neuromodulation for patients with urge incontinence, urgency-frequency, or urinary retention.

    Urge Incontinence3

    sns-5yr-urge

    • 59% of urge incontinent patients achieved > 50% reduction in leaks/day.*
    • 71% of those urge incontinent patients who reported heavy leaks at baseline achieved > 50% reduction in leaks/day†

    *59% in evaluable patient population (n=61) and 37% in intent-to-treat population (n=96)
    †71% in evaluable patient population (n=49) and 42% in intent-to-treat population (n=84)
     

    Urgency Frequency3

    sns-5yr-freq

    56% of urgency-frequency patients achieved > 50% increase in volume voided/void and improved degree of urgency*

     

    *56% in evaluable patient population (n=18) and 40% in intent-to-treat population (n=25)

     

    Urinary Retention3

    sns-5yr-ret

    78% of urinary retention patients achieved > 50% reduction in volume/catheterization*

    *78% in evaluable patient population (n=23) and 58% in intent-to-treat population (n=31)

    Study Purpose
    This post-approval, non-randomized, multicenter study provided data on the long-term effects of Sacral Neuromodulation (delivered by the InterStim System) for the treatment of urinary urge incontinence, urinary urgency-frequency, and urinary retention in patients who had failed or could not tolerate more conservative treatments. The study took place at centers in the U.S., Canada, and Europe.

    Results
    The study demonstrated that Sacral Neuromodulation can be a long-term solution for patients with overactive bladder or non-obstructive urinary retention.

    Refer to the InterStim Therapy Clinical Summary 2011 for detailed information regarding the study results.

    Adverse Events
    The most common adverse events experienced during clinical studies 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.

    For additional safety information, please refer to Indications, Safety, and Warnings.

     

    References
    1. Siegel S, Noblett K, Mangel J, et al. Neurourol Urodyn. Article published online: January 10, 2014 DOI:10.1002/nau.22544.
    2. Coyne KS, Matza LS, Thompson CL, Kopp ZS, Khullar V. J Urol. 2006;176(2):627-632
    3. Medtronic-sponsored research. InterStim Therapy Clinical Summary 2011.

     

    Clinical Efficacy for Bowel Control

    Chronic fecal incontinence often causes profound emotional distress leading to social withdrawal and isolation. The InterStim® Therapy for Bowel Control Prospective Clinical Study demonstrates that Sacral Neuromodulation for Bowel Control (delivered by the InterStim System) is safe, effective, and may offer your patients improved quality of life.1,2

    Clinical studies offer proof positive that Sacral Neuromodulation effectively helps patients, who have failed or could not tolerate more conservative treatments, gain control of their fecal incontinence symptoms.

    Proven Symptom Decline

    The InterStim Therapy for Bowel Control Prospective Clinical Study demonstrates a statistically significant decline in fecal incontinence 12 months post implant.

    • 41% of patients achieve complete continence*2
    • 83% of patients achieve ≥50% reduction in incontinent episodes per week*1,2
    • 83% of patients achieve ≥50% reduction in incontinent days per week**1,2
    • 80% of patients achieve ≥50% reduction in urge incontinent episodes per week***1,2

    This study uses two statistical analyses: per-protocol analysis and intent-to-treat analysis (see below for definition). Results are similar, demonstrating a statistically significant and clinically relevant reduction in fecal incontinence severity for subjects implanted with the InterStim Therapy system (p<0.0001).

    Per-protocol analysis (also referred to as completers analysis): conducted with patients who had complete data at baseline and annual follow-up visits.

    Intent-to-treat analysis (also referred to as modified worst case analysis): Assumed no improvement for patients who were missing bowel diaries (tool used to measure symptom improvement from baseline) at follow-up visits, unless a subsequent bowel diary was available.

    * 41% in per-protocol analysis (n=106) and 36% for intent-to-treat analysis (n=120) for complete continence

    ** 83% in per-protocol analysis (n=106) and 73% for intent-to-treat analysis (n=120) for both weekly incontinent episodes and days per week (p < 0.0001)

    *** 80% in per-protocol analysis (n=106) and 71% for intent-to-treat analysis (n=120) for urge incontinent episodes per week (p < 0.0001)

    More Effective Than Optimal Medical Therapy

    A randomized control trial by Tjandra et al. demonstrates that the InterStim System at 12 months post implant (n=53) is more effective than supervised optimal medical therapy consisting of bulking agents, pelvic floor exercises, and dietary management. Fecal continence was greatly improved with chronic sacral neuromodulation after implantation and was sustained during the follow-up period.3

    InterStim Therapy Results

    • 47% of patients achieve complete continence
    • 66% of patients achieve 75% – 100% improvement in incontinent episodes per week

    Optimal Treatment Results

    In the supervised optimal medical therapy group, there are no significant improvements in fecal incontinence symptoms, Wexner scores, FIQOL Index, and SF-12 scores.

    Adverse Events

    The safety profile for the InterStim System for Bowel Control is similar to the InterStim System for Bladder Control, which was originally approved by the US Food and Drug Administration in 1997.

    The InterStim Therapy for Bowel Control Prospective Clinical Study shows no unanticipated adverse device effects, no patient deaths related to the neurostimulator or therapy, and no surgical injuries during the test or implant procedures.1,2

    Most adverse events are successfully treated with medication or device reprogramming. The most common adverse events (n=120) are implant site pain, paraesthesia, implant site infection, change in sensation of stimulation, urinary incontinence, and diarrhea. The probability of the patient having surgical revision (including device replacement) within the first year is about 10%.2

    For additional safety information, please refer to Indications, Safety and Warnings.

    Significant Improvement in Patient Quality of Life

    Sacral Neuromodulation may offer patients freedom from the embarrassing and socially isolating symptoms of fecal incontinence. Study data demonstrate significant improvement in patient quality of life, including physical and psychological well-being, as determined by a variety of accepted measures.


    FIQOL Index – InterStim Prospective Clinical Study

    The InterStim Therapy for Bowel Control Prospective Clinical Study shows significant improvement at 12 months in all four scales of the Fecal Incontinence Quality of Life (FIQOL) Index.2,4†

    The results are very similar for the per-protocol analysis and intent-to-treat analysis (see tables below), demonstrating a statistically significant and clinically relevant improvement in FIQOL scores for subjects implanted with the InterStim system (p<0.0001).

    † The FIQOL Index is composed of 29 questions that form four scales. Each scale is the average score of all items in the scale and ranges from 1 to 4 (lifestyle, coping/behavior, and embarrassment) or 1 to 5 (depression/self-perception). A lower score indicates a lower functional status or quality of life.


    FIQOL Index – Randomized Control Study: Sacral Neuromodulation vs. Optimal Medical Therapy

    In the Tjandra study, InterStim Therapy patients show sustained improvement post implant for FIQOL Index scores (n=53, p<0.0001).3 InterStim Therapy significantly improves all domains of the FIQOL Index (see table below), whereas optimal medical therapy (n=60) shows no effect at 12 months.

    Adverse events with the InterStim System in this study include implant site pain, especially in slimmer patients; seroma, resolved after percutaneous aspiration; and excessive tingling in the vaginal region.3

    FIQOL_Score_Change

    *PNE: Peripheral Nerve Evaluation, a temporary test stimulation used to determine the probable effectiveness of the InterStim System implant.


    Quality Scales

    A study by Hetzer et al. demonstrates significant improvement across all QOL scores. InterStim Therapy significantly improves median Wexner scores at 6 months (69%, p<0.001). Patients show a reduction of incontinence symptoms—thus dramatically enhancing QOL, including social lives.5

    In addition, InterStim Therapy significantly improves generic and incontinence-specific QOL at 6-month follow-up:4

    • SF-36 QOL Questionnaire: Scores improve in all eight categories and significantly improve for physical functioning, social function, mental health, and vitality (p<0.05).
    • Gastrointestinal QOL Index Score: Median preoperative score improves from a preoperative score of 96 to a postoperative score of 107 (0-144 rated, p=0.02).
    • Bowel-Specific Royal London Hospital QOL Questionnaire: All median subscores of this bowel-specific questionnaire improve (lifestyle, coping and behavior, depression and self-perception, and embarrassment). See table below.
    • Adverse events in the Hetzer study include infection, seroma and loss of effect. Eight patients (22% or 8 out of 37 implanted patients) experienced complications that required surgical intervention. (A successful restimulation was possible for 5 of these patients.) Adverse effects of SNS were remedied in 5 patients by reprogramming the stimulator.

    Change in QOL, Royal London Hospital Questionnaire

    InterStim Therapy improves all subscores of the Bowel-Specific Royal London Hospital QOL Questionnaire at 6-month follow-up (p<0.05).5 Score range 0-100.

    fiqol_score_change2

    Additional Quality Measures

    The InterStim Therapy for Bowel Control Prospective Clinical Study shows patients’ average perception of their own bowel health increases 106% from baseline to a more favorable state at 12 months post implant. Where zero indicates the worst imaginable state and 10 indicates the best imaginable state, self-rated bowel health scores improve from 3.53 at baseline to 7.28 at 12-month follow-up (n=106, p<0.0001).4

    Use of undergarment protection all of the time decreases from 64% of patients at baseline to 37% of patients at 12 months post implant.1,2 In addition, the percentage of patients reporting no use of undergarment protection improves, going from 3% at baseline to 31% at the 12-month visit.4

    References
    1. 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.
    2. Medtronic-sponsored research.

    United States