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Bladder Pacemaker For Urinary Retention

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

InterStim® Testing Procedure Treatment for Urinary Disorders (part 1)

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:

  • Reversible.
  • 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.

How Does It Work

SNM uses mild electrical pulses to stimulate the sacral nerve located near the tailbone, which controls the bladder and other muscles that manage urinary function. A pulse generator device the size of a stopwatch, is surgically implanted into the buttocks. The pulses are delivered near the sacral nerve through an insulated wire called a lead, which is also implanted under the skin.

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.

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What Is Involved In The Permanent Pacemaker Or Stage 2 Interstim Implant

The patient and doctor decide together before the 2nd stage procedure if the InterStim® device has made enough of a difference to symptoms to proceed to the permanent pacemaker implant.

If this is the case, under an anaesthetic a small cut is made in the buttock skin and the pacing wire is connected to the permanent InterStim® pacemaker device which is implanted deep to the fat of the buttock.

The device is controlled by a hand held patient programmer with no external visible wires. Patients are given extensive education in how to use the patient programmer that is usually no more complicated to use than a mobile phone. Usually settings do not need to be changed on a regular basis using the patient programmer.

The InterStim® device is left on continuously and fine-tuning of programmes or settings occurs over the first few months depending on urinary symptoms.

What To Expect After The Device Is Implanted

Bladder Pacemaker

Most patients will notice a slight pulling or tingling sensation, according to Medtronic, which manufactures the InterStim devices. These sensations should not be painful if they are, contact your doctor. Sudden movement can also cause a change in how the stimulation feels, because the device shifted in proximity to your sacral nerve. This doesnt affect the effectiveness of the stimulation has changed. After a few weeks, patients typically report they dont notice the sensation anymore.

The goal is for InterStim therapy to help patients return to their daily routines without worrying about bowel or urinary incontinence. A successful procedure should help patients be more confident of their ability to go through life, taking long walks, traveling or visiting a movie theater. Things that were difficult become possible, once patients are no longer worried about incontinence.

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Bladder Pacemaker Restores Urinary Control

MEDIA CONTACTS: Ruthann Richter at Stanford, 723-6911, or Diana Marszalek at UCSF, 476-2557

EDITORS, REPORTERS PLEASE NOTE: A diagram with caption is attached.

FOR IMMEDIATE RELEASE

BLADDER PACEMAKER RESTORES URINARY CONTROL

Just as a cardiac pacemaker helps maintain a steady heartbeat, a new bladder pacemaker helps men and women with debilitating bladder problems regain control of this vital function, according to UCSF Stanford Health Care physicians, who pioneered the technology.

The implantable bladder pacemaker delivers a painless electrical stimulus to the nerve fibers that regulate the muscle of the bladder. This enables patients to control urine storage and release, said Dr. Emil Tanagho, a UCSF professor of urology whose early work with paraplegics and quadriplegics led to the development of the device.

He and Dr. Rodney Anderson, a Stanford professor of urology, are among the three physicians in California — and the only two in Northern California — who are currently implanting the device. The Food and Drug Administration approved the device in September 1997.

Tanagho said the new pacemaker may benefit patients suffering from urge incontinence, the inability to control the strong, sudden urge to urinate. It could also help people with severe bladder problems associated with multiple sclerosis, Parkinson’s disease, interstitial cystitis or pelvic pain produced by overactive pelvic muscles, he said.

Implanted under skin

Few treatment options

A patient’s perspective

What Are The Differences Between Axonics Interstim Ii And Interstim Micro

InterStim II

  • About the size of a silver dollar, 44mm x 51 mm
  • Doesnt require recharging
  • Needs to be replaced about every five years

InterStim Micro

  • Smallest SNM device available, 17 mm x 47 mm
  • Requires charging for 20 minutes, once a week
  • Needs to be replaced about every 15 years

Axonics Therapy

  • About the size of a quarter, 23 mm x 45 mm
  • Requires wireless charging for about an hour, once a month
  • Needs to be replaced about every 15 years

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Pacemaker For The Bladder Helps Control Incontinence

It’s a problem nobody wants to talk about, suffering in silence and embarrassment. Of the 25 million Americans living with incontinence, 80% are women.

But a pacemaker for the bladder may be the answer.

“I couldn’t go 20 minutes without having to go to the bathroom,” Melissa DerManouel said.

She suffered for 12 years with overactive bladder.

“If it starts to go, there’s no stopping mechanism,” DerManouel said.

For people like DerManouel, their brains and their bladders don’t communicate correctly. So, she was the first person in the United States to receive the new Axonics Sacral Neuromodulator, a remote-controlled pacemaker for the bladder.

“Basically, we’re reprograming the nerve to the bladder,” Dr. Felicia Lane said.

The neurostimulator is surgically implanted in the lower back, near the third sacral nerve root. A small lead wire delivers electrical impulses to the nerves that regulate bladder control.

“Our bladder can store our urine or hold our urine longer, and we’re not having these involuntary contractions of the bladder that are unwanted,” Lane said.

In previous devices, patients would need a new surgery to replace the stimulator every four years when the batteries died. The new stimulator lasts 15 years and can be charged just by wearing this charger over the area the device was implanted.

“There’s nothing better than to see a bathroom and walk by it and not have to go,” DerManouel said.

MEDICAL BREAKTHROUGHS

TOPIC: PACEMAKER FOR THE BLADDER

REPORT: MB #4696

Percutaneous Tibial Nerve Stimulation

Interstim Therapy: A Patient’s Story

Percutaneous tibial nerve stimulation involves applying gentle electrical stimulation to the tibial nerve, which spans from the foot to the spine, improving bladder function and reducing how often you urinate and get up in the night with urgency incontinence.

Your NYU Langone urologist inserts a needle that is very fine, similar to those used in acupuncture, near the ankle. The needle is actually an electrode that delivers low-voltage electrical impulses through a nerve in the leg up to nerves that control the bladder muscle.

The procedure lasts 30 minutes and is performed once a week for 12 weeks in the doctors office. Follow-up treatments range from every few weeks to every few months.

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Helps Control Bladder Function

The new treatment is like a pacemaker for the bladder, said Smith. It helps control bladder function by filtering signals that may be causing the problem.

“With overactivity, the treatment blocks the signals telling the brain to go often,” said Smith. “With urinary retention, it filters signals to the lower pelvis to allow the pelvic muscles to relax and the bladder muscles to contract.”

InterStim is recommended for patients who have not had success with diet and behavioral changes, or oral medications.

Inserting The Interstim Therapy Device

Since nerve stimulation is not an answer for everyone, there is a test trial period before the InterStim device is implanted. Doctors perform the test phase procedure in an operating room or a medical office. The doctor will numb a small area and insert a thin, flexible needle near the tailbone. This needle will be attached to a wire placed near the sacral nerves.

A small amount of electrical stimulation will test the patients sensation to find the best placement. A person can expect to feel a comfortable vibration, pulsing or tingling in the area of the vagina or rectum.

Once the doctor has located the optimal location, the temporary testing wire will be secured and attached to an external battery, which can be placed on the patients belt. The patient will have a remote to adjust the level of stimulation. This allows each patient to tailor the device to meet his or her needs.

The testing period will take between 1-3 weeks. During this time the doctor will ask the patient to complete a bladder diary to track daily urinary habits.

If there is improvement in the urinary or fecal symptoms, the second stage of the procedure will be performed to implant the permanent battery in the upper part of the buttock. The battery is similar to a heart pacemaker.

With both procedures, the patient will be able to go home the same day, but will need a driver.

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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.

Who Is Not Suitable For Treatment With Sacral Neuromodulation

Doctors Use Pacemaker

InterStim® therapy is not recommended for usage in:

  • People in whom the stage 1 trial or test stimulation was unsuccessful
  • People who are unable to properly operate the hand held patient programmer
  • People with urinary blockage
  • Movement or migration of the pacing lead
  • Mechanical problems with the device
  • Interactions with other devices or diagnostic equipment such as MRI
  • Changes in urinary or bowel function which are undesirable

Most of these problems can be resolved by changes in programming parameters of the InterStim® device.

Some patients with the permanent InterStim® device need reoperation before the pacemaker battery needs replacement due to:

  • Reduced or loss of effectiveness of the InterStim® device
  • Pain at the lead or pacemaker site
  • Infection of the device

It is thought that reoperation rates are reducing over time with refinements in the InterStim® device implantation techniques and equipment.

Dr. Karen McKertich

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Interstim Therapy At A Glance

  • InterStim Therapy, which treats overactive bladder, urinary incontinence, urinary retention and fecal incontinence, involves sending electrical pulses to the sacral nerves, located in the lower area of the spinal cord.
  • The sacral nerves affect bladder and bowel function.
  • Of the more than 225,000 patients treated by InterStim for bladder and bowel control therapy, 85 percent achieved success in the first year.
  • Before the InterStim device that generates the electrical pulses is surgically implanted, the patient will have a trial period to assure the therapy will reduce condition symptoms.

Effectiveness Of Interstim Devices For Bowel Incontinence

In study results published in the medical journal Annals of Surgery, 120 patients and their doctors tracked the effectiveness of the therapy.

  • About half of the patients experienced total recovery of bowel control and reported no incontinence problems for one year after the surgery
  • 30% reported that their bowel leaks were reduced by more than 50%
  • InterStim therapy produced significant positive results for more than 8 out of 10 patients

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Stimulate Relief With Dr Paul Jo

If parts of your body are struggling to do their job, theyâre in need of a boost. The InterStim® system can give your urinary system that boost.

Dr. Paul Jo is experienced in treating incontinence and implementing the InterStim® system in patients. Dr. Jo has decades of experience researching and successfully treating urinary issues. Dr. Jo will analyze your condition and symptoms, determine the cause of your incontinence if not already known, and work with you to create a plan for success.

Best Life: Pacemaker For The Bladder

An Interstim Success Story

LOS ANGELES, Calif. — Its a problem nobody wants to talk about suffering in silence and embarrassment. Of the 25 million Americans living with incontinence, 80% are women.

A pacemaker for the bladder may be the answer.

Its a sweet treat today for Melissa DerManouel. Its so sweet because days like these were few and far between.

I couldnt go 20 minutes without having to go to the bathroom, DerManouel said.

DerManouel suffered for 12 years with an overactive bladder. If it starts to go, theres no stopping mechanism, she explained.

For people like DerManouel, their brains and their bladders dont communicate correctly.

DerManouel was the first person in the United States to receive the new Axonics sacral neuromodulator–a remote-controlled pacemaker for the bladder.

Felicia Lane, MD, UC Irvine, told Ivanhoe, Basically were reprograming the nerve to the bladder.

The neurostimulator is surgically implanted in the lower back, near the third sacral nerve root. A small lead wire delivers electrical impulses to the nerves that regulate bladder control.

Our bladder can store our urine or hold our urine longer and were not having these involuntary contractions of the bladder that are unwanted, Lane said.

In previous devices, patients would need a new surgery to replace the stimulator every four years when the batteries died. Now, the new stimulator lasts 15 years and can be charged just by wearing a charger over the area the device was implanted.

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What Is Sacral Neuromodulation

Sacral neuromodulation or a bladder pacemaker is a treatment used to help thousands of people with bladder control problems. It is also known as Interstim therapy.

The brain controls the bladder by sending electrical signals down nerve pathways that run from the brain, to the spinal cord, and through the lower back called the sacral area. These sacral nerves control the muscles in the pelvic floor, the bladder and those needed for urinary control. Bladder sensations are also relayed via these nerves to the brain. Sacral neuromodulation helps to correct inappropriate, unwanted or even erroneous messages sent along these nerve pathways.

Bladder Pacemaker Restores Urinary Function: 8/98

Implanted bladder pacemakerrestores control of urinary function

Just as a cardiac pacemaker helpsmaintain a steady heartbeat, a new bladder pacemaker helps men andwomen with debilitating bladder problems regain control of thisvital function, according to urologists at Stanford and UCSF whopioneered the technology.

The implantable bladder pacemakerdelivers a painless electrical stimulus to the nerve fibers thatregulate the muscle of the bladder. This enables patients tocontrol urine storage and release, said Dr. Emil Tanagho, a UCSFprofessor of urology whose early work with paraplegics andquadriplegics led to the development of the device.

Tanagho and Dr. Rodney Anderson, aStanford professor of urology, are among the three physicians inCalifornia and the only two in Northern California arecurrently implanting the device, which was approved by the FDA inSeptember 1997.

The new pacemaker may benefitpatients suffering from urge incontinence, the inability to controlthe strong, sudden urge to urinate. It could also help people withsevere bladder problems associated with multiple sclerosis,Parkinson’s disease, interstitial cystitis or pelvic pain producedby overactive pelvic muscles.

Once installed, the device isexternally programmed by the physician to send electrical impulsesto the nerves. This signals the bladder and pelvic muscles tocontract or relax as urine is stored or eliminated. Patients canalso regulate the device, within certain set limits, by turning itup or down.

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How Does Sacral Neuromodulation Work

The most widely studied form of sacral neuromodulation uses the InterStim® device . InterStim® works by delivering an electrical message to the sacral nerves which modify abnormal reflexes in the sacral and pelvic nerves that supply the bladder and pelvic floor, as well as modifying abnormal communications between the brain and bladder.

These abnormal reflexes may cause problems with:

  • An overactive bladder with frequency, urgency and urge urinary incontinence as well as
  • Some cases of urinary retention or inability to empty the bladder that are NOT related to blockage in the urinary tract

Sacral Neuromodulation For Bladder Control

Best Life: Pacemaker for bladder

InterStim Therapy for Urinary Control treats urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency. It should be used after you have tried other treatments such as medications and behavioural therapy and they have not worked, or you could not tolerate them.

You should have a successful trial assessment before receiving InterStim Therapy. If you dont have an appropriate response to test stimulation or are unable to operate the neurostimulator then Interstim Therapy may not be the best treatment option for you. You cannot have diathermy if you have an InterStim device and this should be discussed with your health care professional

InterStim Therapy is not intended for patients with a urinary blockage. Safety and effectiveness have not been established for pregnancy and delivery patients under the age of 16 or for patients with neurological diseases such as multiple sclerosis. Your health care professional should discuss if Interstim therapy is an appropriate choice for you.

In addition to risks related to surgery, complications can include pain at the implant sites, new pain, infection, lead movement/migration, device problems, interactions with certain other devices or diagnostic equipment such as MRI, undesirable changes in urinary or bowel function, and uncomfortable stimulation .

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