Neuro InterStim Bowel Brochure
Contents
1. system is implanted Yes Sexual activity is not restricted if you have an implanted InterStim Therapy system Will a microwave oven interfere with the normal operation of the neurostimulator Generally no Most home appliances do not affect the way your neurostimulator operates Can the neurostimulator battery be recharged No it cannot be recharged The battery is sealed inside the neurostimulator and is not rechargeable The battery lasts for several years and is then replaced by changing the neurostimulator via a simpler surgical procedure where the electrode is not replaced Will the InterStim Therapy limit my activities Normally you will have no restrictions while carrying out your activities But you should avoid activities that involve sudden excessive or repetitive bending twisting bouncing or stretching especially soon after the surgery These movements could damage or move your implanted lead or affect the implanted neurostimulator Contact your doctor if you have any concerns or questions about these or other activities Usually movements do not affect the sensation of the stimulation However quick movements or changes in posture may move the implanted lead This can feel like an unexpected increase in stimulation even though the stimulation level has not changed If at any time you find the stimulation bothersome use your patient programmer to turn the stimulation level down or Off Tell your doctor2. show it to the medical staff before you undergo tests or treatments The beprer Of the cod Ae an PLATED LAT SS TEM that m ued tn dear ecto glen oo Re ape cond or peripheral meerines Frequently asked questions on long term InterStim Therapy What is the size of the InterStim neurostimulator There are 2 possible sizes and weights height x length x thickness 44cmx5 1cmx0 8cm 22g 5 5cm x 6 0 cm x 1 0 cm 42 g Will people be able to see it Since your system is placed completely under your skin others will not see it What am supposed to do with the patient programmer The patient programmer is used to know whether the stimulation is active or deactivated to turn it ON or OFF to know your level of stimulation to increase or decrease it to know whether the battery is low or not and in some cases to change your stimulation parameters to other settings preset by your doctor What do I do if the stimulation becomes uncomfortable If the stimulation becomes uncomfortable use your patient programmer to decrease the stimulation level Will the stimulation keep me awake at night No it should not If it does contact your doctor Can InterStim therapy be used during pregnancy The safety of this therapy for use during pregnancy has not been established If you think you are or might be pregnant turn OFF your InterStim system and call your doctor Can have sex after my InterStim
3. to turn your INS on or Off Hardly bigger than a 2 Euro coin the case of the neurostimulator is made of titanium a strong light and biocompatible metal ideal for a safe and comfortable long term implant What happens during the implant If you performed the evaluation phase with a temporary electrode then a permanent electrode will be implanted close to the nerves in your lower back If the evaluation phase has been performed with a permanent electrode this procedure can be avoided The electrode is then connected to the small implantable neurostimulator which will be inserted under the skin in the upper buttock where it will be most comfortable and cosmetically acceptable for you This minimally invasive procedure may take an hour and can be done under local anaesthesia What happens after the implant Your doctor will program the stimulation parameters to reproduce what you experienced during the evaluation phase Your implantable neurostimulator will run continuously 24h day for many years and will be invisible under the skin incision wound Once at home gradually increase your activity level as your incision heals On your doctor s advice you will be able to resume an active lifestyle Your awareness of the neurostimulator will gradually diminish and you may not even feel its presence Normally your doctor will schedule a visit at 1 month after the implant to check the efficacy of the stimulation parameters and to a
4. SD Medtronic Therapy InterStim FOR BOWEL CONTROL PROBLEMS Bowel control problems can be embarrassing and debilitating They can have a major negative impact on lifestyle as well as on both physical and psychological health leading to depression loss of confidence loss of self esteem You may have to cut back on your hobbies stop working feel trapped by a fear of leaking accidents or feel the need to be close to the bathroom at all times Nerves carry information to and from the brain Some nerves control the bowel and muscles that relate to defaecation When the communication system between these nerves and the brain is not working properly a person may have bowel problems such as faecal incontinence and constipation InterStim Therapy also called sacral nerve stimulation or sacral neuromodulation in the literature was developed in the early 1980s and was approved in Europe in 1994 It can improve quality of life by eliminating or greatly reducing the symptoms suffered by patients with Faecal incontinence Constipation InterStim Therapy helps to restore normal nerve activity so that you can defecate normally It uses a small implanted medical device to send mild electrical pulses to a nerve located just above the tailbone InterStim Therapy is performed in 2 phases Evaluation phase Implant phase Patients who experience relief from their symptoms during the evaluation phase may be candidates for a
5. dapt them accordingly Sometimes several visits are necessary to fine tune the settings during the first 3 months Otherwise you may only need a yearly check up What happens when the neurostimulator battery runs down After several years the neurostimulator battery runs down the electrical stimulation may change and become less effective Your symptoms may then reappear but this is normal and there is no need to worry You should consult your doctor as soon as you feel a change in the stimulation less or more intense or different He or she will check the battery and may decide to replace the neurostimulator Your patient programmer will also warn you if the neurostimulator battery is low Your doctor uses a physician programmer to adjust all your neurostimulator settings and to estimate the battery life Electricity governs everything from the transmission of thought to the rhythm of the heart Our body is full of cells behaving as mini batteries to deliver vital electricity In fact life itself is defined as the presence of electrical activity in the brain In the end electricity is life 7 5 q Tre eer cu Lire Electricity has been used in medicine since the days of the Romans to treat pain with the discharge of the electric torpedo fish Since the 1st external wearable pacemaker was invented by Medtronic in the late 1950s physicians found that electricity can alleviate symptoms in an astonishing number of illnes
6. elf reported Definition in a Population based Survey in Spain Am J Epidemiol 2004 159 520 526 2 Adapted from Dykstra et a Treatment of OAB with Botox type B a pilot study Int Urogynecol J 2003 14 424 426 3 Matzel et al Sacral spinal nerve stimulation for faecal incontinence multicentre study Lancet 2004 363 1270 76 4 Michael Arndt Rewiring the body BusinessWeek Online March 7 2005 Please always consult the InterStim Therapy Guide and or your patient programmer User Manual to get the instructions for use Important Safety Information Refer to technical manual for complete list of indications contraindications warnings and precautions InterStim Therapy for Urinary and Bowel Control Product technical manual must be reviewed prior to use for detailed disclosure Indications InterStim Therapy is indicated for the management of chronic intractable functional disorders of the pelvis and lower urinary or intestinal tract Contraindications Diathermy Patients who have not demonstrated an appropriate response to test stimulation or are unable to operate the neurostimulator Precautions Adverse Events Safety and effectiveness have not been established for patients with pregnancy unborn fetus and delivery or for pediatric use under the age of 16 The system may be affected by or adversely affect cardiac devices electrocautery defibrillators ultrasonic equipment radiation therapy MRI theft detectors screening device
7. ere with the signal that your doctor wants to diagnose In such cases your stimulation can be turned off during monitoring Theft detectors and screening devices Airport screening systems or theft detectors found in public department stores or banks can cause the neurostimulator to turn OFF or ON Do not worry It does not change your stimulation parameters Use your patient programmer to switch your neurostimulator to what it was before To avoid possible problems with airport screening systems you may want to show your InterStim identification card and ask those in charge to let you bypass the screening device If you must pass through the theft detector or security screening device turn your neurostimulator OFF approach the centre of the screening gate and walk through normally Commercial equipment Commercial electrical equipment for example arc welders induction furnaces as well as high voltage power lines may interfere with your neurostimulator system if approached too closely Please mention this to your doctor if you work in such an environment i Contraindication Anyone who has an implanted InterStim Therapy system even if it is turned OFF CANNOT have any shortwave diathermy microwave diathermy or therapeutic ultrasound diathermy all now referred to as diathermy anywhere on their body a It is a good idea to carry your InterStim identification card with you at all times and
8. if you experience any significant or recurring problems May dive after my InterStim neurostimulator is implanted Yes but do not dive below 10 meters of water or enter hyperbaric chambers above 202 65 kilopascals kPa 2 0 ATA Before diving or using a hyperbaric chamber discuss the effects of high pressure with your doctor Are the sensations felt during the evaluation phase different than the sensations felt with the InterStim system No the sensations are aimed to be the same Should I turn the neurostimulator OFF to urinate or defaecate Usually not but check with your doctor Do have to switch OFF the stimulation from time to time No it should run continuously day and night or as your doctor has programmed it to run How do I know if the neurostimulator is OFF Turn your patient programmer ON press the Sync button GS If you see this icon on the top left part of the screen your neurostimulator is OFF If you see this icon then it is ON Learn more about the treatment options by visiting www bladderbowel co uk This is a patient education web site about bowel incontinence It provides information about what incontinence is what healthcare services are available and what treatments might be offered References 1 Adapted from Garrigues et al Prevalence of Constipation Agreement among Several Criteria and Evaluation of the Diagnostic Accuracy of Qualifying Symptoms and S
9. ng or tapping in their pelvic area vagina scrotum or anus or big toe It should never be painful and the stimulation can be adjusted at any time The sensations will fade away with time just as you would no longer notice trains anymore if you live nearby a railway for along time Please make sure your doctor has answered all of your questions and you understand clearly how the system works before you go home What should I do once at home The evaluation phase may be performed for several days You can continue to lead your everyday life and record your symptoms in your bowel diary Please try to avoid intense physical activities that could displace the electrode Avoid bending stretching or lifting heavy objects How to use the Verify evaluation system The Verify evaluation system consists out of two components the external neurostimulator ENS and the Controller The ENS delivers the stimulation and is worn in a belt the controllers serves to adjust stimulation if necessary or to check the battery status The stimulation parameters are set by your doctor during the procedure You will be able to adjust the stimulation intensity by using the increase or decrease key on your Controller You find further information in the Quick Guide of the Controller or the Patient Instructions In case you need to shut off the stimulation you will be able to do it via the Controller or directly on the ENS Your Controller sho
10. permanent implant like more than 100 000 patients worldwide Different types of bowel control problems With faecal incontinence you may e Have diarrhea e Feel the urgent need to go to the toilet and or not reach the toilet on time e Have constipation e Stain or soil your underwear With constipation you may e Have infrequent stools lt 3 times a week Pass hard and dry stools e Have some difficulty defaecating e Often feel your rectum is not completely empty even after going to the bathroom InterStim Therapy evaluation phase The evaluation is a temporary phase used to measure the efficacy of the InterStim Therapy in your daily life It is the only tool which can give an indication of the long term outcome of the therapy How is the evaluation setup An electrode a thin wire is inserted near the nerves in your lower back that control the bowel This electrode is then connected to an external stimulator which delivers mild electrical pulses to the nerves This procedure normally takes less than an hour and can be done under local anaesthesia Two types of electrodes can be used for the evaluation either a temporary electrode that will be removed after the evaluation or a long term electrode that will remain implanted if the evaluation is positive What does the stimulation feel like Stimulation sensations vary from person to person but most people describe them as light pulling tingli
11. s Adverse events include pain at the implant sites new pain lead migration infection technical or device problems adverse change in bowel or voiding function and undesirable stimulation or sensations including jolting or shock sensations For full prescribing information please contact your Medtronic representative www medtronic eu Europe United Kingdom Ireland Medtronic International Trading S rl Medtronic UK Ltd Route du Molliau 31 Building 9 Case postale Croxley Green Business Park CH 1131 Tolochenaz Watford Switzerland Hertfordshire WD18 8WW Tel 41 21 802 70 00 UK Fax 41 21 802 79 00 www medtronic co uk Tel 44 0 1923 212213 Fax 44 0 1923 241004 yy Medtronic UC200801225cEE 2012 Medtronic Inc All Rights Reserved Printed in Europe
12. s not move and does not get wet Are sport activities limited Restrict your physical activities during the evaluation phase due to the risk of the electrode moving from its initial position Do I have to fill in a bowel diary Yes you have to fill it in during the evaluation phase and a few days afterwards Please try to complete it as well as you can as itis used to measure and predict the efficacy of the therapy May have sexual intercourse It s not recommended to have sexual activity during the evaluation phase as it could displace the electrode from its correct positioning it will then be possible with the permanent implant Is the evaluation reversible Yes the evaluation is reversible stimulation can be shut off at any time and the leads can be permanently removed if necessary i Me If your symptoms did NOT improve the evaluation may be repeated with a different type of electrode and or in a different location InterStim Therapy Implant Phase If the evaluation phase was successful your doctor may propose you the implant of an InterStim system What is an InterStim system The InterStim system consists of e An implantable neurostimulator INS which is like a pacemaker implanted under the skin e An electrode that carries the mild electrical pulses to the nerves controlling the bowel e A hand held patient programmer that enables you to adjust the level of the stimulation and allows you
13. ses in most parts of the human body A few million Europeans are currently treated with an implantable electrical stimulator to treat conditions such as heart rhythm disease chronic pain Parkinson s disease deafness urinary and faecal incontinence or constipation Such therapies are not only clinically effective but they also produce fewer side effects than most known drugs InterStim Therapy is safe completely reversible and can be turned off at any time What precautions do need to know about Medical procedures and equipment Before you undergo medical tests or treatments always tell your medical and dental professional that you have an implanted neurostimulation system With proper precautions most medical procedures and routine diagnostic tests such as fluoroscopy or x ray should not affect your InterStim system However the following medical equipment and treatments may adversely affect you and your InterStim system e Heart defibrillators e Lithotripsy e g for kidney stones e Radiation therapy over the neurostimulator e Radiofrequency RF microwave ablation e Ultrasound scanning equipment It is also important that you let your doctor know that you have an InterStim device before you get diagnosed with monitoring devices such as an electrocardiogram ECG a Holter Monitor an electroencephalogram EEG oran implantable heart monitor as the pulses from your neurostimulation system may interf
14. ws the status of the Verify ENS batteries and the status of the Controller batteries In case batteries are low the Controller will show a message prompting to replace it Basic Evaluation Dual ENS Do you know that the InterStim evaluation will indicate in only a few days if the InterStim Therapy is effective for you Controller Your follow up visit At the end of the evaluation phase you will meet with your doctor to review your bowel diary to check if your symptoms have improved and to decide if the therapy is appropriate for you If a temporary electrode was used for the evaluation or if the evaluation failed whatever the type of electrode this electrode will be removed Be aware that your bowel symptoms will most likely return within a few hours after stopping the stimulation Please complete your bowel diary thoroughly as it will log very important information for your doctor a i gt a7 Frequently asked questions on the evaluation May work Yes you can except if your work requires intense physical activities May use my mobile phone Yes you can there is no problem May shower or take a bath Please avoid bathing You may shower 48h after the procedure depending on the type of dressing and electrode you have Please check with your doctor In any case we recommend to take a sponge bath in such a way that the electrode doe
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