InterStim™ Therapy - Premier Health Specialists
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1. tingling or tapping in their pelvic area vagina scrotum or anus or big toe It should never be painful The sensations will fade away with time just as you would no longer notice trains anymore if you live nearby a railway for a long 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 test period may be performed for several days During this period you can continue to lead your everyday life and record your symptoms in your voiding diary Please try to avoid intense physical activities during the test period that could displace the electrode Avoid bending stretching or lifting How to use the test stimulator The test stimulator has 2 large dials on top The one labelled R sets the stimulation frequency It is set by your doctor and is usually protected Do not adjust it The second dial labelled A sets the amplitude of the stimulation It is initially set by your doctor but you will be instructed to find the best setting for you Please reduce the amplitude toa comfortable level for you should you feel any pain To shut the stimulation off simply turn the A dial to OFF The top of the test stimulator also has 2 indicator lights a green blinking light when the unit is on and a yellow light that shows when the battery needs to be changed Your follow up visit At the e2. i rk a he i i ai z h 4 i h s k i i n ee e 7 3 _s r F j i F z _ DEEDE I lll InterStim Therapy is safe completely reversible p and can be turned off at any time eeoeeeee 4ec08ceeeee0ee3ae3eue e3eoee3ex ee5uoeo3w ee3ee3aeoe3e3ue7es e30ae7x5eee3eoee eese3aeueseeo enseeneeee3e3e eee eeee8 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 InterStim 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 gt gt Heart defibrillators gt Lithotripsy e g for kidney stones gt gt Magnetic resonance imaging MRI gt gt Radiation therapy over the neurostimulator gt gt Radiofrequency RF microwave ablation gt 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 or an implantable heart monitor as the pulses from your neurostimulation system may interfere with the signal that your doctor wants to diagnose
3. In such cases your stimulation can be turned off during monitoring 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 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 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 It is a good idea to carry your InterStim identification card with you at all times and show it to the medical staff before you undergo tests or treatments Se NEUIROS THLUILATION
4. Medtronic Alleviating Pain Restoring Health Extending Life
5. the skin in the upper buttock where it will be the 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 test stimulation Your implantable neurostimulator will run continuously 24h 24 for many years and will be invisible to everybody 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 adapt 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 neu
6. Irwin et al Population Based Survey of Urinary Incontinence Overactive Bladder and Other Lower Urinary Tract Symptoms in FiveCountries Results of the EPIC Study European Urology 2006 50 1306 1315 2 Dykstra et a Treatment of OAB with Botox type B a pilot study Int Urogynecol J 2003 14 424 426 3 Adapted from Foster et al In Patients Undergoing Neuromodulation for Intractable Urge Incontinence a Reduction in 24 hr Pad Weight After the Initial Test Stimulation Best Predicts Long Term Patient Satisfaction Neurourol Urodyn 2007 26 2 213 7 4 van Voskuilen et al Long Term Results of Neuromodulation by Sacral Nerve Stimulation for Lower Urinary Tract Symptoms A Retrospective Single Center Study Eur Urol 2006 49 2 366 72 5 Blok et al Different brain effects during chronic and acute sacral neuromodulation in urge incontinent patients with implanted neurostimulators BJU Int 2006 98 1238 1243 6 Dasgupta et al Changes in brain activity following sacral neuromodulation for urinary retention Urol 2005 174 6 2268 72 7 Michael Arndt Rewiring the body BusinessWeek Online March 7 2005 Europe and UK Please always consult the InterStim Therapy Guide Medtronic International Trading Sarl and or yo tent User M l Route du Molliau 31 your patient programmer User Manua Case postale to get the instructions for use CH 1131 Tolochenaz Switzerland Tel 41 0 21 802 70 00 Fax 41 0 21 802 79 00 www medtronic co uk UC200801226 EE
7. SYSTEM j PATIENT IDEMTIFICA TION The bearer of this cord has an IMPLANTED HEURGCSTIMULATION STS TEM fhial i used io Guino Scio shmulasen to the sgenal cord of peripheral reves deme Piuma Cartel HiT mgit Cah Lard baci Paben s Mama Hom Patient Adkins Adres ra ki Tas ey jean ep ee En cm dugig CEE Phic a Wd eres Pioi Prone Mamber Pu de ale rr Li ee BY The rie res 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 e 4 4 cm x 5 1 cm x 0 8 cm 22 g e 5 5 cm 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 I 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 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 p
8. a gt Medtronic InterStim Therapy For Bladder Control Problems Patient Guide Break taboos Take control Get treatment If you have incontinence you are not alone Bladder Control Problems affect over 45 million people in Europe making it more prevalent than many well known diseases such as asthma diabetes or osteoporosis It is neither strictly a female problem nor a normal part of ageing Did you know that InterStim Therapy can also treat faecal incontinence or constipation alone or in combination with your urinary problems Ask for more information from your doctor Bladder Control Problems Bladder control problems can be devastating You may leak small or large volumes of urine use the bathroom very frequently or not be able to completely empty your bladder These conditions interfere with your life and can make simple everyday activities a challenge and social life very difficult You may have to cut back on your hobbies or stop working You may feel trapped by a fear of leaking accidents the need to be close to the bathroom at all times and an overall preoccupation with your bladder Why do I have Bladder Control Problems Nerves carry information to and from the brain Some nerves control the bladder and muscles that relate to urination When the communication system between these nerves and the brain is not working properly a person may have bladder problems such as urinar
9. e end Please try to complete it as well as you can as it is used to measure and predict the efficacy of the therapy May I have sexual intercourse Yes if you have the long term electrode and provided that you avoid brusque gesture Yes th t can be stop ka b amp A TEN If your symptoms did NOT improve the test stimulation may be repeated with a different type of electrode and or in a different location ee EE gt yy ys y T t InterStim Therapy Implant Phase If the test stimulation was successful your doctor may propose the InterStim Therapy to you What is an InterStim system The InterStim System consists of gt An implantable neurostimulator INS which is like a pacemaker implanted under the skin gt gt An electrode or thin wire that carries the mild electrical pulses to the nerves controlling the bladder gt gt A hand held patient programmer that enables you to adjust the level of the stimulation and allows you 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 not already done during the test stimulation the long term electrode will be inserted close to the nerves in your lower back The electrode is then connected to the small neurostimulator which will be inserted under
10. ence e urgency frequency InterStim Therapy helps to restore normal nerve activity so that you can urinate normally It uses a small implanted medical device to send mild electrical pulses to a nerve located just above the tailbone Go for the InterStim Test You can only win InterStim Therapy is performed in 2 stages gt gt Test phase gt gt Implant phase Patients who experience relief from their symptoms during the test stimulation may be candidates for a permanent implant like more than 40 000 patients worldwide InterStim Therapy Testing Phase The test stimulation 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 test setup An electrode a thin wire is inserted near the nerves in your lower back that control the bladder This electrode is then connected to an external stimulator worn on a belt 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 test either a temporary electrode that will be removed after the test or a long term electrode that will remain implanted if the test is positive What does the stimulation feel like Stimulation sensations vary from person to person but most people describe them as light pulling
11. nd of the test period you will meet with your doctor to review your voiding diary to check if your symptoms have improved and decide if the therapy is appropriate for you If a temporary electrode was used for the test or if the test failed whatever the type of electrode this electrode will be removed Be aware that your bladder symptoms will most likely return within a few hours after stopping the test stimulation Please complete your voiding diary thoroughly as it will log very important information for your doctor Do you know that the InterStim test will indicate in only a few days if the InterStim Therapy is effective for you 4 Frequently asked questions on the test May work Yes you can except if your work requires intense physical activities May I use my mobile phone Yes you can there is no problem May I 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 you may clean yourself with a wet glove in such a way that the electrode does not move and does not get wet Are sport activities limited Restrict your physical activities due to the risk of the electrode moving from its initial position especially if you have a temporary electrode Do I have to fill in a voiding diary Yes you have to fillit in during the test period anda few days after th
12. regnancy 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 I have sex after my InterStim system is implanted Yes Sexual activity is not restricted if you have an implanted InterStim Therapy system 10 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 The battery is sealed inside the neurostimulator and is not rechargeable It cannot be replaced without replacing the entire neurostimulator Will the InterStim system 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 stimula
13. rostimulator 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 The Energy of Life from the transmission of thought Electricity has been used in medicine since the days of the Romans to treat pain with the discharge of to the rhythm of the heart Our the electric torpedo fish Since the Ist external wearable pacemaker was invented by Medtronic body is full of cells behaving as in the late 1950s physicians found that electricity mini batteries to deliver vital can alleviate symptoms in an astonishing number of illnesses in most parts of the human body A few electricity In fact life itself million Europeans are currently treated with an is defined as the presence of implantable electrical stimulator to treat conditions such as heart rhythm disease chronic pain electrical activity in the brain In Parkinson s disease deafness urinary and faecal a ae incontinence or constipation Such therapies are the end electricity is life not only clinically effective but they also produce fewer side effects than most known drugs Many more conditions such as severe depression migraines anxiety obesity Alzheimer s disease and bulimia may all be treated with neurostimulators a type of implantable electrical stimulator in the near future
14. tion bothersome use your patient programmer to turn the stimulation level down or Off Tell your doctor if you experience any significant or recurring problems May I 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 test different than the sensations felt with the InterStim system No the sensations are aimed to be the same Should turn the neurostimulator OFF to urinate or defecate f Usually not but check with your doctor Do I have to switch OFF the stimulation from time to time No it should run continuously day and night How do I know if the neurostimulator is OFF Turn your patient programmer ON press the Sync button If you see this icon D on the top left part of the screen your neurostimulator is OFF If you see this icon A then it is ON on my own 7 dout have to think about cath night U feels like a gift Learn more about the treatment options by visiting www bladder control co uk This is a patient education web site about urinary incontinence It provides information about what incontinence is what healthcare services are available and what treatments might be offered References 1 Adapted from
15. y retention and over active bladder including urgency urinary incontinence and urgency frequency Different types of bladder control problems With urgency urinary incontinence you may e Lose urine as soon as you feel a strong need to go to the bathroom e Leak urine when you cannot get to the bathroom quickly enough e Leak urine when you drink even a small amount of liquid or when you hear or touch running water With urgency frequency you may e Have frequent uncontrollable urges to urinate e Go to the bathroom more often than normal gt 7 times a day e Often feel your bladder is not completely empty even after going to the bathroom With urinary retention you may e Spend a long time at the toilet but produce only a weak dribbling stream of urine e Leak urine also called overflow incontinence e Not have a sensation when your bladder is full e Have to use a catheter to empty your bladder InterStim Therapy can significantly improve your quality of life and eliminate or reduce the need to take medications What is InterStim Therapy 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 your quality of life by eliminating or greatly reducing the symptoms for many people suffering from gt urinary retention gt gt over active bladder including e urgency incontin
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