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Sacral Neuromodulation

  • Education and Training
  • Efficacy
  • Products and Procedures
  • Reimbursement and Practice Management
  • Indications, Safety, and Warnings
  • Post-implant Education and Patient Care

    Post-implant Follow-up

    Long-term post-surgical management ensures the greatest benefit from Sacral Neuromodulation. Regular patient follow-up is necessary to ensure the InterStim® System is providing optimal therapy outcomes, confirm component integrity and performance, and assess neurostimulator battery life.

    Postoperative Management

    Before discharge, the patient should be instructed to:

    • Inform all health care professionals, such as consulting physicians and dentists, that he or she has an implanted neurostimulation system
    • Avoid physical activities that may damage the implant site or the implanted neurostimulator or dislodge parts of the system.
    • Restrict activities such as stretching and lifting heavy objects, for a period of time following surgery to minimize the possibility of lead displacement
    • Consult the physician if any unusual signs or symptoms develop
    • Carry the Medtronic patient identification card and patient programmer with them at all times
    • Consult the InterStim Patient Therapy Guide for answers to questions about how the therapy may affect their day-to-day life.

    Follow-up

    Periodic visits should be scheduled after the surgery to verify programming parameters and fine-tune the Sacral Neuromodulation therapy.

    The Patient Management Guide offers suggested best practices for systematic, objective patient management. It is used as a guide post-implant with the Patient Management Worksheet to assess symptoms and program settings and guide programming decisions.

    Medtronic offers an online Virtual Patient Training Program to help clinicians gain expertise with managing patients who have an InterStim System.

    Go to the Virtual Patient Training Program

    Programming

    Clinician Programming

    The neurostimulator is generally activated the day of surgery. The touchscreen on the N’Vision® clinician programmer is used to review and program each of the stimulation parameters. Settings should be adjusted on a case-by-case basis to:

    • Provide optimal patient symptom relief
    • Minimize patient discomfort
    • Maximize neurostimulator battery life

    Battery life can vary depending upon the following:

    • Programmed parameters (amplitude, rate, pulse width, and number of active electrodes)
    • System impedance
    • Hours per day of stimulation
    • Degree of patient control over programmable stimulation parameters

    Programming Parameters

    A program defines the stimulation pulses that will be delivered for therapy and is a specific combination of pulse width, rate, and amplitude settings (along with other optional parameters), acting on a specific electrode combination. Each patient requires a unique stimulation pattern to alleviate the symptoms and the primary goal of programming is to create a stimulation pattern that can provide optimal symptom relief. A secondary goal is to prolong battery life using the optional stimulation patterns.


    Programming Guidelines

    Programming can be performed by a trained physician or a trained nurse in the post-surgery recovery room or in the physician’s office. Patients can remain seated and clothed for programming and have a spouse or companion in the room.

    A neurostimulator is typically programmed during one or both of these situations:

    • Initially, just after the neurostimulator is implanted. Depending on the practice, this can be in the post-surgery recovery room or in the office, a day* to a week after the neurostimulator has been implanted. Initial programming may involve one initial programming session and additional reprogramming sessions for making adjustments.
    • Later, after the initial programming sessions. If the patient is not getting relief from the symptoms, if the symptoms have reappeared, or if there is discomfort or loss of stimulation, you may need to review and reprogram the initial settings. Typically, patients are reprogrammed as a result of a routine evaluation, pain or discomfort, or due to a lack of efficacy.1

    The Model 3058 neurostimulator should be allowed to stabilize at body temperature for at least one week before conducting Therapy Measurements. The battery capacity and longevity measurements provided prior to this period or prior to implant may be lower than expected.

    During a programming session, the N’Vision clinician programmer and the model 8870 InterStim software are used to create and define programs to be installed or programmed into the neurostimulator.

    For details about programming and optimizing neurostimulator battery longevity, refer to the InterStim Therapy Programming Guide

    Patient Programmer Use

    Patients should be instructed in the use of the InterStim iCon® patient programmer model 3037 and the control magnet (for patients with InterStim model 3023 only). The patient programmer allows patients to fine-tune sensory stimulation to a comfortable level.

    Patient-controlled functions include:

    • Increasing or decreasing the amplitude within clinician-defined limits
    • Turning the neurostimulator "ON" or "OFF"
    • Switching among up to 4 different pre-set stimulation programs

    To switch between clinician-defined programs, the patient programmer must be held over the neurostimulator, against the clothing or skin. The programmer has an optional antenna attachment that facilitates neurostimulator programming when the patient finds the neurostimulator difficult to reach (e.g., with buttock placement of neurostimulator).

    Patients can become familiar with their programmer functions by reviewing the InterStim iCon Patient Programmer Patient Manual and watching a series of videos available on www.everyday-freedom.com/life. Those same videos also appear below.

    References
    1. Burks FN, Ananais C, Lajiness MJ, et al. Sacral Neuromodulation Reprogramming: Is It an Office Burden? International Urogynecology Journal. 2008:19(8):1137-1140.

    Manuals and Other Resources

    Clinician Manuals

    N'Vision Clinician Programmer Technical Manual

    This guide presents technical programming information and usage for the N'Vision® clinician programmer model 8840, which is used with InterStim® II and InterStim sacral nerve neurostimulators. The manual includes an overview and description, as well as the use, maintenance, troubleshooting, and specifications of the programmer

    N'Vision Clinician Programmer Model 8840 and Application Card Model 8870 Programming Guide

    Use this programming guide for software version B 08/05 supporting the InterStim model 3023 and InterStim II model 3058 sacral neuromodulation systems. This programming guide provides instructions on how to use the N'Vision Clinician Programmer model 8840 with the corresponding InterStim application card model 8870 to program, adjust, and troubleshoot the InterStim model 3023 and InterStim model 3058 neurostimulator system.

    Patient Manuals

    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 how the therapy may affect their day-to-day life.

    InterStim iCon® Patient Programmer Patient Manual

    This is the patient user manual for the InterStim iCon patient programmer model 3037.

    Resources

    Patient Management Guide

    This document offers suggested best practices for systematic, objective patient management.

    Patient Management Worksheet: Bladder Control and Bowel Control

    This tool is used to track thresholds and programming settings pre-implant, at time of surgery, and post-implant. Symptom diary input can also be included to assess treatment outcome.

    United States