InterStim Therapy – What to Expect, What You Need to Know, Tried and True Tips and What You Physician or Rep May Not Have Told You
This is an extremely long post but after reading so many posts from patients requesting information on InterStim or hearing from those who have had the Trial or Permanent Implant and commented about issues that encountered, I believe it may be beneficial. I find that many posts imply that they were not told any of this prior to the surgery or may believe they were mislead or talked into getting InterStim without really understanding about this Therapy. Others mentioned pre-existing conditions that probably should have raised red flags to their doctor that perhaps because of those issues that they should not have been referred for InterStim. I hope the information I am providing will help anyone considering the device or will provide additional information to those having questions about or issues with their device.
This is directly off the Medtronic Website: InterStim should not be considered or recommended as a first choice treatment for Bladder or Bowel conditions and the patient should have tried and failed or been unable to tolerate more conservative treatments. For Bladder Control, Urodynamics testing is normally performed since it provides the most accurate diagnosis of a patient’s urinary symptoms by evaluating the bladder and urethral sphincter muscles. InterStim for Fecal Incontinence generally requires a combination of two or more assessment techniques to evaluate defecation function since there is no single objective study that can definitely assess all aspects of anorectal function. Sacral neuromodulation (SNM) is not appropriate for patients who primarily experience stress incontinence, may require an MRI, have neurogenic OAB or urinary retention, experience urinary retention due to mechanical obstructions such as benign prostatic hypertrophy, cancer, or urethral stricture or someone who is unable to operate the device. The safety and effectiveness of SNM have note been established for patients who are pregnant, under age 16, have neurological diseases such as multiple sclerosis or diabetes or require bilateral stimulation. Also, (this is not from the Medtronic site as the previous information was) persons with previous back injuries, fibromyalgia and/or leg or nerve pain may want to discuss their medical history concerning these conditions in much more detail with their doctor prior to proceeding with the implant. I would also suggest getting clearance from whatever physician is treating those conditions as I have read many, many posts on this site about how the InterStim implant surgery and/or the stimulation from the device negatively affects these conditions to the point that the device was removed but the problems persisted even after removal.
The two types of evaluation for InterStim Therapy are the basic and the advanced evaluation and are used for either urinary or bowel control issues. In both evaluations, a portable, external stimulator generates the stimulation which is delivered via a lead. Both evaluations are short term (up to 7 for the basic and up to 14 days for the advanced) and the effects are reversible by removing the leads or turning off the device. In the Basic, a flexible, thin wire lead is used and is easily removed after evaluation and only has one electrode contact. The Advance Eval uses a flexible lead with tines that anchor into place and remains for long-term therapy after a positive evaluation and has four electrode contacts that provided more programming options. The lead that is used in the Advanced Eval is the same one that would be used for the Permanent Implant Phase for patients who had the Basic Eval. Local anesthesia (numbing agent to site) is normally all that is used during the Basic Evaluation and during the Advanced or Permanent Implant Stage monitored anesthesia care or genera anesthesia may be used. Unless you have General Anesthesia where you are put to sleep, you will most certainly feel and be aware of everything your physician is doing during the procedure. This is necessary because they need to ask you what and where you are feeling the test stimulations they use to determine whether they found the nerve they selected to target. Some physicians rely solely on the Nerve Innervation Response Sensation that is visible when they stimulate the S2, S3 or S4 nerve but does not provide the feedback the direct conversation with the patient provides. There are several methods that can be used to close the entry wounds you will have during the Trial and Permanent Implantation Surgeries. If a temporary test lead is used during a Basic Eval, it may only be held in place by a clear dressing and/or some surgical tape and is easily dislodged and may actually fall out before the end of your Test Phase. For the Advanced Eval or Permanent Implantation Surgery, they may use sutures, staples of surgical glue to close all incisions. With sutures or staples you will normally have a bandage that will need to be changed and you may be instructed not to bathe or shower until the sutures or staples are removed. Closure using surgical glue allows you to shower the day after surgery and does not require a bandage but one can be worn if the area is sensitive where clothing might rub. The healing time with surgical is usually quicker than if the wounds are closed with sutures or staples.
1) Using Ice Packs 24/7 following any Phase of InterStim Surgery will reduce or eliminate any pain at the incision sites, and will prevent or minimize bruising, swelling or hematoma development. The best ones to purchase are the ones used for lower back issues and have a cloth covering with Velcro Straps that can be secured around your waist to hold the Ice Pack in place even when you are up and walking. Purchase at least 2-3 so you will always have a frozen one available to replace the thawed one you were using. This type of Ice Pack can be worn under or over your clothing throughout the day and night.
2) You may want to purchase some type of small squishy pillow to use as a cushion over the site until it heals or for the times when you may need to sit for long periods of time in a hard or uncomfortable chair. The smallest size of Pillow Pets (the children’s toy that when closed is a stuffed animal pet and when open, serves as a pillow) is perfect for this.
3) Once you have your Permanent Surgery, keep a small notebook or piece of paper with you at all times and jot down notes about your experience as you try each Program. Do not change Programs too frequently as it make take your body time to adjust to any change so allow a minimum of two weeks on each Program before deciding it is not working. The exception to that rule is if a Program causes intense pain that is not eliminated by turning down the intensity. You should divide your notes by each Program and should include the time of day, what you are doing at the time, where you are feeling the sensation and how it feels, whether your symptoms are being controlled, etc. Provide as much detail as possible and do not be afraid to be blunt or even crude in your description. Similar to word association, you need to describe it with the first thing that comes to mind such as “it feels like I am sitting on a stick up my butt” or “it feels like I am getting stung by bees” or “it feels like someone is beating a drug on my vagina or rectum (or wherever) or “I have a constant fluttering sensation, like a humming”. All these descriptions will help your programmer adjust the internal settings on your device to find your perfect setting.
4) Every Patient needs to understand that InterStim is not a quick-fix Therapy and it is rare for a patient to get their Implant, go home from the Hospital on a Program that is perfect, requires no programming tweaks and controls 100% or their symptoms. It may take week, months or more than a year of trial and error before the right Program is found that will control whatever condition the InterStim was implanted to fix. Also, the Trial device works differently from the Permanent device and someone who had great results during the Trial Phase may find that (initially) they do not get the same relief they had during the Trial. This is normal and that is when the patient enters the re-programming/tweaking phase of InterStim which is why the notebook journal is so important. You (as well are your doctor or programmer) needs to be determined and committed to doing whatever it takes for as long as it takes to find the correct Program no matter how many visits that may require.
There are only two things a Patient can change on their own thru the Hand Held Device they are given and that is what Program you want to use and the Intensity of the stimulation on that Program. There are multiple changes your Doctor or Programmer can make “internally” to your device that will change how each Program works and where it is felt. Those changes are the Program Parameters and it is important to understand what each one does and how it affects the stimulation your device provides. Make sure you ask for and receive get a written record of the different items listed below for each Program on your device whenever a change is made.
1) Program – this defines the stimulation pulses that will be delivered and is a specific combination of Amplitude, Pulse Width, Rate and Electrode Polarity.
2) Amplitude – the intensity or strength of the stimulation measured in volts. Increasing amplitude increases the intensity of the stimulation and decreasing it will reduce what is felt.
3) Pulse Width – the time or duration of the stimulation pulse. Increasing the width increases pulse duration and decreasing it will decrease the pulse duration.
4) Rate – the number of times per second a pulse is delivered. Increasing the rate feels more like a “flutter” or “vibration” and decreasing the rate feels more like a “thumping” sensation.
5) Electrode Polarity – the stimulation pulse is delivered from the Neurostimulator (battery or generator) to the nerve through the electrodes on the leads. For the stimulation pulse to reach the nerve, you must select the electrodes on the lead that best provides the stimulation and assign it a negative or positive polarity. At least one electrode (or the Neurostimulator case) must be designated as positive and at least one electrode must be negative. The negative electrode is called the active electrode; a pulse flows from the active or negative electrode to the positive. Thus, changing an electrode to active, changes the location of the stimulation. Each lead has four electrodes numbered 0, 1, 2, 3 with electrode 0 situated in the most distal location. Typically, stimulation pulses from distal electrodes are felt more anterior and more proximal electrodes are felt more posterior. Configuring electrodes depends on how the leads and electrodes are placed in relation to the nerve that is being stimulated.
6) SoftStart/Stop – The SoftStart/Stop feature allows the amplitude to increase gradually (ramp up) over a specified period. This feature is intended to increase patient comfort by providing a gentle or “soft” start as stimulation begins and reduces the risk that the patient will be startles by the start of a stimulation cycle. This feature also causes the output to decrease gradually (ramp down) when the stimulation is turned off.
This is definitely not everything a person should know about InterStim and I will be glad to provide more details and try and answer any questions someone may have. To clarify, I am a nurse as well as an InterStim patient and not employed by Medtronic. What I have provided here is information I have read from information and the programmer and patient manuals they have available on their Website in addition to information provided by my own physician and her nurse and programmer.