Interstim Device For Urinary Incontinence

What Is Interstim Sacral Nerve Stimulation Therapy And How Does It Prevent Urinary Incontinence

InterStim® is a sacral nerve stimulation therapy that allows you to regain bladder and bowel control. When an overactive bladder is causing incontinence, InterStim®, which is a small device placed near the pelvis, engages with the sacral nerves, stimulating them through pulses.

The sacral nerves control your bladder and bowel, and allow certain pelvic functions. A neurostimulator and lead in the device work together to stimulate the sacral nerve electrically, restoring proper neural activity, meaning that your brain and bladder will be in sync, enabling your urinary system to function properly.

The InterStim® system is:

• Conducted with a small device.
• Designed to send electrical impulses to the sacral nerves.
• Capable of lessening or stopping incontinence and other bladder-related issues.

The InterStim® device is inserted in the body through a minimally-invasive procedure conducted under anesthesia.

Instructions For After The Procedure

You will have follow up appointments with your doctor to make sure the device is programmed in the best way to control your symptoms. You will receive a remote control device to control stimulation, and you may see the InterStim nurse or technician as needed to adjust settings for optimal benefit. This may take a few visits after the initial implant. Once the most appropriate settings are determined, you will need to be followed annually or as needed. Patients can expect up to 6 years of benefit before the device may need to be replaced due to battery depletion.

What Are The Side Effects

The SNM procedure is very safe and has not been associated with any death. The majority of adverse events experienced were of a relatively minor nature. In a report to the Medical Services Advisory Committee of Australia:

• The most commonly reported clinical adverse events were

• Pain of undefined location and severity

• Pain specifically at the implanted pulse generator site

• Lead migration was reported at 7%

• Approximately 16 % of patients required lead revision or replacement, frequently in order to optimise the clinical effectiveness of the device

• Device removal was reported at a rate of 9.9% in the implanted patients. This is usually done because of infection, lost efficacy, or pain.

If you want to know whether sacral neuromodulation can help your bladder problems, contact us.

For more specific information on the Testing Phase procedures and instructions and the Implant Phase read Sacral Neuromodulation User Info.

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How Long Has Sacral Neuromodulation Been Around

The InterStim System received its CE mark for the treatment of chronic intractable function disorders of the pelvis, lower urinary and intestinal tract in 1994. Today over 225,000 patient have been treated worldwide. Itâs a proven treatment option for people who have not had success with more conservative urinary retention treatments.

Sacral Neuromodulation And Interstim For Overactive Bladder

Sacral neuromodulation is regarded as a 3rd line treatment for patients with overactive bladder i.e. after medications and bladder retraining with pelvic floor physiotherapy have been unsuccessful in controlling symptoms.

Patients are regarding as having refractory symptoms when they have not responded to or do not tolerate at least 2 of the newer medications available for OAB symptoms.

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Will Interstim Treatment Work For Me

A simple in-office procedure initiates an evaluation to determine in as few as 3-7 days whether an implanted InterStim® system is likely to provide long-term control over symptoms.

Your doctor will discuss the evaluation procedure with you and the options for using either a temporary lead or long-term lead for the evaluation. You and your doctor will decide together whether your evaluation was successful. The evaluation is considered a success if you experience a significant reduction in your symptoms.

For example, your evaluation may be considered a success if you went to the bathroom 20 times per day before the evaluation and went 10 or fewer times per day during the evaluation.

How Will I Know If Interstim Therapy Works For Me

You and your doctor will decide together whether your evaluation was successful. The evaluation is considered a success if you experience a significant reduction in your symptoms.

For example, your evaluation may be considered a success if you went to the bathroom 20 times per day before the evaluation and went 10 or fewer times per day during the evaluation.

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Interstim Implants For Urinary Or Bowel Incontinence

Incontinence is often the result of a miscommunication between the brain and the bladder and/or bowels. InterStim therapy, a type of sacral neuromodulation or sacral nerve stimulation therapy, works to re-establish this very important communication channel. Incontinence Institute offers three implanted sacral neuromodulation devices:

Criteria For Success And Lack Of Long

Clinical success has been defined as an improvement of 50% or more in symptoms during testing. This definition seems somewhat arbitrary and problematic. Some patients may just attain the threshold of being classified as responders to SNM , while other patients may have a substantially greater response. Bosch addressed this limitation. He stated that a report of success using a binary endpoint for testing and after implantation based on a more than 50% threshold grossly overestimates the benefits of this treatment.9 The clinical heterogeneity in endpoints have rarely been discussed or addressed. A 50% improvement, while receiving pharmacological therapy, would hardly be considered a success by most patients, especially if they are suffering from OAB or UUI.10 Results using a more stringent definition for SNM success would be valuable.

An important consideration was that not all patients who were satisfied with the SNM testing underwent implantable pulse generator insertion. About 7% to 10% of patients, who expressed improvement in symptoms when tested, did not undergo IPG implantation.11,12 Moreover, 20% of successful peripheral nerve evaluation will not experience the same efficacy after their permanent lead placement supporting the use of a tined lead.9

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Anticholinergic Therapy Vs Onabotulinumtoxina

CITATION:

Anthony G. Visco, M.D., Linda Brubaker, M.D., Holly E. Richter, Ph.D., M.D., Ingrid Nygaard, M.D., et al, for the Pelvic Floor Disorders NetworkNew England Journal of Medicine 2012 367:1803-1813, November 8, 2012DOI: 10.1056/NEJMoa1208872

Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence.

RESULTS:The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group . Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively .

NOTES:With full resolution numbers ranging from 13%-27% after 6 months of continued use, it appears the overall effectiveness is quite limited for both oral medications and Botox injections.

Side Effects And Complications Of Interstim Implantation

When discussing the risks of the Interstim for treatment of OAB symptoms, it is important to keep in mind that every medical therapy is associated with side effects. In this respect, the percentage of patients who experienced adverse effects with Interstim was 30.5% versus 27.3% of patients on medical therapy alone.

Rare complications of the procedure include undesirable stimulation resulting in small shock sensations and changes in bowel function. The electrical signal strength may need some fine-tuning in these cases, which will require a follow-up visit. Until the site has healed properly, you will be advised to take it easy and may need to limit your physical activity. But, the idea is that you can return to a better quality of life after everything heals. In fact, a study published in 2014 concluded that not just the physical symptoms, but other psychological factors, also improved after using Interstim. The women interviewed in the study were less depressed and their perception of body image had improved dramatically.

In general surgical risks include:

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Interstim Can Provide Relief For Patients Experiencing Symptoms Of An Overactive Bladder

Incontinence and overactive bladder can restrict what you do. We would like to help you get back to living a life filled with the activities you love.

About a third of Americans suffer from incontinence, but precise numbers are not available because many people are uncomfortable talking about the subject. With advances in medical techniques and technology, Proliance Puyallup Surgeons is able to offer you more treatments for incontinence and overactive bladder than ever before.

InterStim Treatment for Incontinence

If you are experiencing incontinence, and medication has not resolved your symptoms, InterStim might be a good option for you. Interstim is used to improve bladder or bowel control.

Why Are Medtronic Therapies Different

COMMUNICATION IS CRITICAL

Evidence suggests that breakdowns in the bladder-brain communication pathway are a root cause of OAB and non-obstructive urinary retention.1-3 While more conservative therapies focus on the bladder muscles, Medtronic therapies target the nerves that control the bladder muscles, which are thought to help restore normal bladder function.*

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Medtronic Bladder Control Therapy Delivered By The Interstim Systems

THE RELIEF YOUVE BEEN WAITING FOR

When lifestyle changes and medications fail, Medtronic bladder control therapy delivered by the InterStim systems can help. This therapy is simple and discreet, and it delivers the kind of relief that lets you enjoy the activities you love without a second thought.

• Targets the nerves that control your bladder to help it function normally again
• 85% of people using the InterStim systems achieved success in the rst year,4
• 3x greater improvements in quality of life compared to medications,,6
• Lets you see if it works before you and your doctor decide
• Allows you to get full-body MRI scans if you need them§
• Hundreds of thousands of people have experienced relief with this safe, FDA-approved and minimally invasive therapy

THE CHOICE IS YOURS

Medtronic bladder control therapy delivered by the InterStim systems oers recharge-free and rechargeable options, so you can choose the right one for your lifestyle.

• The recharge-free InterStim X system may be best for most people it’s convenient and low maintenance.
• The rechargeable InterStim Micro system is smaller, lasts longer, and requires regular recharging sessions.

The Best Solution For Overactive Bladder

Advanced Interstim is an amazing treatment to permanently fix overactive bladder with incredible precision. It is done as an outpatient in our state of the art surgery centers with the best outcomes. Advanced Urology has the only Medtronic Center of Excellence in the World. We are the best in fixing OAB. Most importantly, we can help you.

DONT STRUGGLE WITH BLADDER CONTROL

Medicines often do not work and have many side effects. Constantly running to the bathroom to urinate or having to wear diapers is detrimental to your health and quality of life. We are experts in urinary control.

ADVANCED TECHNIQUES: BETTER OUTCOMES AND LESS SIDE EFFECTS

Advanced Interstim is a proprietary technique utilizing Medtronics Sacral Nerve Stimulation technology that provides the best outcomes with minimal side effects. This is similar to implanting a small pacemaker or nerve stimulator for the bladder. We utilize Advanced technology with 3D geospatial mapping to precisely fix the root cause of overactive bladder. This targeted millimeter accuracy improves outcomes and minimizes side effects. Urologists from around the world come to Advanced to learn from our talented team.

HOW DOES ADVANCED INTERSTIM WORK?

3 STEP JOURNEY TO SUCCESS

INITIAL VISIT

MINOR TESTING

MINOR PROCEDURE

ADVANTAGES OF ADVANCED INTERSTIM

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Benefits Of The Axonics System

Patients considering a third-line therapy solution for overactive bladder could benefit from the following:

• The system has a rechargeable battery that lasts approximately 20 years. Typically, patients will need to recharge the devices battery once every 4 to 6 weeks for about an hour.
• The system includes a charging belt that charges the battery, and a re-charge free remote control that communicates with the stimulator to detect when it is working, and signals the patient when the battery needs to be recharged.
• The device is MRI compatible so patients are able to undergo full-body imaging without having the device removed.
• Patients undergo an external trial of the device prior to having it permanently implanted. The trial consists of having the patient wear a small, disposable device, for a short period of time, to help them determine if the therapy provides them with notable symptom reduction.

The Process For Getting An Implant

The InterStim system consists of a neurostimulator and an electrode both of which are implanted in the lower back with small incisions and a wireless remote control. The neurostimulator sends the signals to the electrode, and the electrode stimulates the sacral nerves. The external wireless device allows you to adjust the signal level and turn the system on and off.

Youll be placed under anesthesia for your procedure, which is performed on an outpatient basis and typically takes about an hour. Unlike other surgical treatments, you can take InterStim for a test run to see if its right for you before making a long-term commitment. The initial evaluation period spans 3-14 days, in which time you can go about your normal routine and track your symptoms to see if there are noticeable improvements in your urge, control and frequency.

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What Is Sacral Neuromodulation

Neuromodulation therapy involves the delivery of tiny electrical impulses to nerves in order to change how they work. Sacral neuromodulation works by changing how the sacral nerves work. These nerves carry messages between the spinal cord and the bladder and their nerve signals are malfunctioning in OAB. Sacral neuromodulation interrupts the abnormal signals and helps to improve OAB symptoms.

Who Is A Candidate For Treatment With Sacral Neuromodulation

InterStim® therapy is approved for usage by Medicare in Australia in people older than 18 years of age whose symptoms have not responded to medical and conservative treatments over at least 12 months due to:

• Overactive bladder due to detrusor overactivity or
• Paradoxically also in patients with urinary retention which is not due to a blockage in the urinary tract

In Australia InterStim® therapy is also approved for use in some patients with refractory faecal incontinence which has not responded to other treatments.

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Medical Moment: Interstim A New Device To Help Deal With Incontinence

– Its a taboo topic that nobody talks about. But 1 in 6 Americans suffer with either urinary or bowel incontinence. Thats more than the number of people with Alzheimers, diabetes, or breast cancer.

Lifestyle changes and medication can relieve symptoms for some, but other patients may require advanced therapies.

An air force captain, a nurse, even a professor with six college degrees under her belt, 70-year-old Linda Brice has lived a unique life, but nearly 20 years ago, she started suffering from a not so unique problem.

I could not feel my legs and I gushed about a quarter more of urine all over the floor and that was kind of my introduction to incontinence, Linda said.

She suffered in silence for years.

You dont want to tell people, I go to the bathroom everywhere, Linda continued.

Medications were not strong enough to treat her symptoms, so doctors suggested she have a device called the Interstim implanted to control them.

It is fundamentally a pacemaker system that helps reregulate these abnormal signaling to the bladder thats resulting in the overactive bladder symptoms, said a Professor of Urology at Vanderbilt University, Melissa Kaufman.

It works by providing electrical signaling to interrupt the abnormal signaling going from the nerves to the bladder. Before, these devices had implantable batteries that would need to be replaced about every five years.

Its given me back my freedom. Its given me back my quality of life, Linda said.

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What Is Interstim Micro

The U.S. Food and Drug Administration recently approved the InterStim Micro neurostimulator, the markets smallest and fastest rechargeable device to deliver sacral neuromodulation therapy. It offers a smaller size compared to InterStim II and a longer battery life. InterStim Micro also allows full-body 1.5 and 3 Tesla MRI conditional scans with SureScanTM MRI technology.

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Stage : The Implantation Of The Internal Stimulator

This procedure is performed under local anesthesia with sedation

• The incision on the buttock area from the first surgery is reopened and a pocket is made in the fatty tissue and the generator placed inside Interstim final implant
• The outside wire is removed
• The procedure takes about 30 minutes and you can go home the same day.
• You should again limit for activities for 7-10 days.

Learn How Interstim Can Remedy Your Urinary Incontinence

Depending on the severity and underlying cause of your incontinence or bladder control issues, conservative treatments, such as medication and behavior modification, may not be enough.

If you struggle to manage your symptoms effectively, you may be a good candidate for InterStim, a type of neuromodulation therapy.

Ahmad Kasraeian, MD, and Ali Kasraeian, MD, offer neuromodulation therapy for urinary incontinence at Kasraeian Urology. Neuromodulation therapy is an advanced treatment that can improve how your brain communicates with the nerves that control your bladder function.

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Am I A Good Candidate

Sacral nerve stimulation may be an effective treatment option if you suffer from an overactive bladder or other forms of female urinary incontinence, urinary retention issues, or urgency-frequency. The InterStim system is not recommended for patients diagnosed with stress female urinary incontinence or urinary obstructions. However, it is crucial to discuss your options with an experienced urologist who can thoroughly examine your specific situation and determine a personalized treatment plan.

Interstim Therapy Sacral Nerve Stimulation Technique

Once it has been decided that the patient is an appropriate candidate for InterStim Therapy, implantation proceeds in 2 steps: a test phase and implantation or lead removal based on test response. The initial test phase may be performed in the office or operating room full implantation is always performed in the operating room under anesthesia.

Preprocedure patient counseling is critical in reassuring the patient and managing treatment expectations. Many patients have extreme apprehension regarding a needle near the spine or a pacemaker-like foreign body implant. We counsel patients that a small wire will be inserted near the tailbone to modulate or positively affect the nerves causing pelvic floor dysfunction. Although battery implantation following a positive test is discussed, the importance and value of the simple and minimally invasive test phase is stressed. Patients are counseled that approximately 60% of patients undergoing office-based test stimulation and 70% undergoing operating room-based test stimulation will have a positive test response. Response is objectively evaluated by pre- and postvoiding diaries assessing various urinary parameters.

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