Implantable Device For Urinary Incontinence

Common Reasons For Repeat Surgery Include:

New device offers relief for patients struggling with overactive bladder

Repositioning of the lead due to a suspected lead moving or breaking
The device stops working and needs replacing
Pain or infection of the device
The battery reaches the end of its life. . The battery will eventually run out and the stimulator device, not the lead, will need to be replaced. The programmer can be used to check the status of the battery. If the battery fails the device will stop working and your symptoms will return.
You develop unwanted effects on bladder or bowel function or sensation.
You need repositioning of the Implantable Pulse Generator due to pain or movement.
You experience transient electrical shocks from the device.
For the above problems the device might need to be either replaced or permanently removed.

Who Will Benefit From Sacral Neuromodulation

Patients with chronic urinary retention, voiding dysfunction, bowel dysfunction and chronic pain syndromes can benefit from this device. Indeed, it may be the only therapy available in some patient groups. In patients with chronic urinary retention, the only known forms of treatment are clean intermittent self-catheterization or indwelling suprapubic/transurethral catheters. At times CISC can be a painful and traumatic process, and SNM offers an effective therapeutic alternative.

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. It’s a proven treatment option for people who have not had success with more conservative urinary retention treatments.

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Who Is Not Suitable For Treatment With Sacral Neuromodulation

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

Ecoin From Valencia Technologies

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Finally, theres the eCoin. Like RENOVA and the StimRouter, the nickel-size device must be implanted in an outpatient procedure.

But unlike other devices, the eCoin is entirely self-contained. Its programmed by a clinician before it goes in to the lower leg, then it automatically provides stimulation at regular intervals so you dont have to think about it.

One drawback is that the battery inside the device must be replaced every three to five years. For anyone who doesnt want to worry about treatment schedules, though, that replacement just might be worth it.

The eCoin is currently recruiting patients for a trial of the device, and results are expected in early 2020.

An Investigation With An Intra

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

First Posted : June 14, 2017Last Update Posted : April 4, 2018

Condition or disease

Layout table for study information

Study Type :
Other
Official Title:	An Open Randomized Controlled Multicenter Clinical Investigation With an Intra-vaginal Device for Stress Urinary Incontinence in Comparison to Using Standard of Care
Actual Study Start Date :

Intervention/treatment
Device: TVSEfficacy of a novel intra-vaginal device for temporary reduction of urine leakage in women suffering from stress urinary incontinence and to evaluate the safety and ease of use.
No Intervention: Standard CareStandard of care : The subjects in the SoC group continued with conventional treatment i.e. using pads during week 1, 2 and 3. They were offered to use the TVS device for two weeks after completion of week 3.

Interstim Therapy Trial Period

InterStim II and InterStim Micro offer a trial device that simulates the actual, implanted device. This is called InterStim Stage 1. Receiving the trial device is a 15-minute, minimally invasive outpatient procedure where the doctor places a lead connected to a small, externally worn device. The external device is worn underneath the patients clothing.

Patients typically wear the trial device between 5-14 days to determine candidacy for a permanent device. During this time, patients log their symptoms to discuss with their doctors. They can continue about their normal activities and experience what it would be like to live with InterStim therapy, how it feels when activated, and if the permanent device will be able to reduce or eliminate their symptoms.

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Pelvic Muscle Training Devices

You can use these products when you do Kegel exercises, which help strengthen and control the muscles you clench when you try to hold in urine. Although you dont need external devices to do Kegels, you may find they help enhance your workout.

There are different kinds of Kegel training devices. Some are aimed at men and women, including appliances you squeeze between your thighs. Vaginal weights, rods, and cones of various sizes are intended for women.

Itâs hard to tell at a glance which items might help you or how some of them work. So do research and talk to your doctor before you buy any of them. Your doctor can help you narrow down the choices.

Interstim Therapy At A Glance

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The root cause of overactive bladder and urge incontinence are the sacral nerve roots, which control the muscle impulses that cause the bladder to expand and contract.

InterStim is an FDA-approved surgical implant device used to treat bladder incontinence and overactive bladder.
The device works by sending mild electric pulses to control symptoms such as leaks and urge incontinence.
InterStim can be reversed or discontinued at any time during therapy.

What Is Stress Urinary Incontinence

Stress urinary incontinence is a leakage of urine during moments of physical activity that increases abdominal pressure, such as coughing, sneezing, laughing, or exercise. SUI is the most common type of urinary incontinence in women.

SUI can happen when pelvic tissues and muscles, which support the bladder and urethra, become weak and allow the bladder neck to descend during bursts of physical activity. This descent can prevent the urethra from working properly to control the flow of urine. SUI can also occur when the sphincter muscle that controls the urethra weakens. The weakened sphincter muscle is not able to stop the flow of urine under normal circumstances and when there is an increase in abdominal pressure. Weakness may occur from pregnancy, childbirth, aging, or prior pelvic surgery. Other risk factors for SUI include chronic coughing or straining, obesity and smoking.

It is important for you to consult with your health care provider for proper diagnosis of SUI.

Image Source: National Kidney and Urologic Diseases Information Clearinghouse

Lifestyle Changes For Urinary Incontinence

First, your doctor is the best source of medical advice. They may suggest options such as prescription medication, surgery, incontinence supplies, intermittent catheterization, or another treatment.

However, you have no need to worry. In fact, you may find that a few lifestyle changes may help reduce the incidence of your urinary incontinence.

For example, your doctor may suggest avoiding substances, foods, and drinks that can irritate the bladder. Diuretics and bladder irritants include nicotine , alcohol, and even caffeine.

In addition, your doctor may also advise you to:

Avoid consumption of diuretics

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What Does Treatment With Sacral Neuromodulation Involve

The InterStim® device works like a pacemaker for the bladder in a similar way that a cardiac pacemaker works for the heart.

Surgery to insert the InterStim® device involves a two staged procedure.

Stage 1 the trial stage involves the insertion of a pacing wire alongside a sacral nerve using X-ray guidance as a day case procedure.

If the trial period is successful in reducing urinary symptoms of bladder overactivity by at least 50%, the patient can proceed to implantation of the full pacemaker device.
The advantage of the trial stage is the ability to test out the InterStim® device over several days to see if it suits the individual before committing to the treatment.
About 7 in 10 patients choose to move from the test stimulation to have the permanent InterStim® pacemaker inserted.

Images supplied courtesy of Medtronic Inc.

Stage 2 the insertion of the permanent InterStim® pacemaker involves the implantation of a device smaller than the size of a box of matches into the fat of the buttock where it cannot be seen.

Images supplied courtesy of Medtronic Inc.

Interstim Therapy A Contemporary Approach To Overactive Bladder

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InterStim therapy is a treatment option for patients with an overactive bladder, a serious case of urine retention or an uncontrollable frequent urge to urinate for reasons other than an overactive bladder. It gets its name from the InterStim, which is a small implantable device used to administer the therapy. There are other forms of treatment for overactive bladders, including medication and physical exercises. InterStim Therapy is used for patients who have failed to respond to the other treatments or who cannot undergo the treatments.

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The Technology Being Reviewed: Sacral Nerve Stimulation

Sacral nerve stimulation is a procedure where a small device attached to an electrode is implanted in the abdomen or buttock to stimulate the sacral nerves in an attempt to manage urinary urge incontinence, urgency-frequency, urinary retention, and fecal incontinence. The device was originally developed to manage urinary urge incontinence however, it has also been used in patients with urgency-frequency, urinary retention, and fecal incontinence. SNS is intended for patients who are refractory to behaviour, drug, and/or interventional therapy.

There are 2 phases in the SNS process: first, patients must undergo a test stimulation phase to determine if they respond to sacral nerve stimulation. If there is a 50% or greater improvement in voiding function, then the patient is considered a candidate for the next phase, implantation.

How Does Sacral Neuromodulation Work

With sacral neuromodulation, a small device is inserted under your skin in your lower back. Small wires, called leads, send low-level, mild electrical impulses to your sacral nerves.

Located near the tailbone, these nerves help with sensation, and control the pelvic floor and the muscles related to bladder and bowel function. Bluetooth technology is used to control the device.

Unlike medications and physical therapy, which target the muscles that control your bladder and bowel function, sacral neuromodulation can offer symptom relief by modulating your nerve signals.

Principle Of Sacral Neuromodulation

The sacral nerves serve the lower urinary tract. To activate or inhibit urinary tract reflexes, SNM delivers mild electrical impulses to the sacral nerves. Besides the local stimulation, neuromodulation also influences the higher centres of bladder control in the brain although its mechanism is not yet clear.The procedure is done in two stages under general anaesthesia. Local anaesthesia is sometimes offered.

Biography Of Tushar Vachharajani

Urinary Incontinence: Transobturator Tape (TOT) Procedure

Tushar J. Vachharajani, MD, FASN is Professor at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in Cleveland, Ohio. He is the Director of Global Nephrology, Department of Kidney Medicine at Glickman Urological and Kidney Institute, Cleveland Clinic, Ohio, USA. He graduated from the Grant Medical College, Mumbai, India and completed additional fellowships in nephrology from St. Bartholomews Hospital, London, UK and Louisiana State University Health Sciences Center, Shreveport, LA, USA. His main interests are in chronic kidney disease, hemodialysis and dialysis vascular access. He has published 200 peer-reviewed articles, book chapters and reviews. Dr. Vachharajani is passionate about educating and improving the procedural skills of the nephrology community around the world.

He is the inaugural Editor of ISN Academy, an online educational portal of the International Society of Nephrology . He serves on the editorial boards of Kidney International Report, Seminars in Dialysis, Journal of Vascular Access, Frontiers in Nephrology and Indian Journal of Nephrology. He has received the 2021 ISN Roscoe Robinson Award, for excellence in education and scholarly activities, 2016 Gerald Beathard Award from American Society of Diagnostic and Interventional Nephrology for excellence in teaching and scholarly activity and 2017 AVATAR Hero Award for his contributions and service.

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What Should I Do After My Surgery To Treat Stress Urinary Incontinence

Continue with annual check-ups and follow-up care, notifying your health care provider if complications develop, such as persistent vaginal bleeding or discharge, pelvic or groin pain, or pain during sexual intercourse. There is no need to take additional action if you are satisfied with your surgery and are not having complications or symptoms.
If you have complications or other symptoms:
Discuss complications and treatment options with your health care provider. Only your health care provider can give you personalized medical advice.
Consider getting a second opinion from a surgeon who specializes in female pelvic reconstruction if you are not satisfied with your discussion with your health care provider.

Let your health care provider know you have a mesh sling, especially if you plan to have another surgery, plan to become pregnant or have other medical procedures.

If you have had SUI surgery but do not know whether your surgeon used a mesh sling, ask your health care provider.

Talk to your health care provider about any additional questions you may have.

Submit a voluntary report about any problems experienced with surgical mesh slings through Medwatch, the FDA Safety Information and Adverse Event Reporting program.

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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.

Background: Condition And Target Population

Urinary urge incontinence, urgency-frequency, urinary retention, and fecal incontinence are prevalent, yet rarely discussed, conditions. They are rarely discussed because patients may be uncomfortable disclosing their symptoms to a health professional or may be unaware that there are treatment options for these conditions. Briefly, urge incontinence is an involuntary loss of urine upon a sudden urge. Urgency-frequency is an uncontrollable urge to void, which results in frequent, small-volume voids. People with urgency-frequency may or may not also experience chronic pelvic pain. Urinary retention refers to the inability to void despite having the urge to void. It can be caused by a hypocontractile detrusor or obstruction due to urethral overactivity. Fecal incontinence is a loss of voluntary bowel control.

Safety Complications And Quality Of Life

A 33% surgical revision rate was reported in an analysis of the safety of 3 RCTs comparing SNS to no treatment in patients with urge incontinence, urgency-frequency, or urinary retention. The most commonly reported adverse effects were pain at the implant site and lead migration. Despite the high rate of surgical revision, there were no reports of permanent injury or death in any of the studies or health technology assessments identified. Additionally, patients consistently said that they would recommend the procedure to a friend or family member.

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What Questions Should I Ask My Surgeon If I Am Considering Surgery To Treat Stress Urinary Incontinence

Ask your surgeon about all SUI treatment options, including non-surgical options and surgical options that do and do not use mesh slings. It is important for you to understand why your surgeon may be recommending a particular treatment option to treat your SUI.

Any surgery for SUI may put you at risk for complications, including additional surgery. One complication that may occur when mesh slings are used is vaginal mesh erosion, which could require additional surgery to resolve.

If mesh erosion occurs through the vaginal tissue, it is possible that men may experience penile irritation and/or pain during sexual intercourse.

Ask your surgeon the following questions before you decide to have SUI surgery:

Will It Work And For How Long

Success of the treatment does vary for different conditions

For urge incontinence about 45% patients were completely dry, 34% had > 50% reduction in number of incontinent episodes and 21% failed the treatment.
For patients with urgency frequency about a third return to a normal number of voids per day, a third have the number of voids reduced by 50% or more and a third fail the treatment.
For urinary retention 61% of patients no longer needed to use a catheter, 16% had to use the catheter less often and 23% failed the treatment.
Patients with neurological conditions generally have much lower success rates, around 20-30%.

Re-operation rates have been reported as high as 50% in some studies. Patients should accept there is a high likelihood of needing further procedures.

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