InVance™ Sling Information Guide

"I like to take care of my body the same way I do my car. If my car breaks down, I fix it. If it has an oil leak, I know it's not going to get better by itself, so I take it to the shop.When I had prostate cancer surgery, I knew stress incontinence was a possible side effect. Sure enough, that's what happened.

Stress incontinence is as constant as that irritating oil drip. If I cleared my throat after brushing my teeth, I'd drip. If I gargled, I'd drip. Any abrupt movement, like laughing or sneezing, caused a leak. I was constantly checking for embarrassing wet spots.

After eight months, I knew it was time to fix "the leak." The AMS InVance™ Sling gave me immediate relief. I was able to go about my busy day without having to worry about wet spots. And best of all, I could pick up my two-year old grandson, joy of my life, without a problem."

- Ben Frausto

*Full interview on file with American Medical Systems

Introduction

You are not alone.

If you suffer from loss of urinary control, you are not alone. Over 25 million Americans of all ages live with this condition, which is known as urinary incontinence. Of these people, many are men just like you.

Incontinence is not a disease, but it can be devastating.

Urinary incontinence is not life threatening, but it can be devastating. Not being able to control your bladder can make even simple everyday activities challenging, if not impossible. Many men drastically restrict their activities and change their lifestyles because they fear embarrassment from odor and wetness, and suffer discomfort from pads and associated rashes. Feelings such as isolation, anger, and depression are, unfortunately, very common.

Incontinence can be treated.

The good news is that you do not have to suffer in silence. Urinary incontinence can be effectively treated, so you can return to a more active lifestyle. The InVance™ Sling from American Medical Systems (AMS) offers the possibility of improved quality of life for men who experience incontinence as a result of prostate surgery.

Find freedom in control.

Your doctor has recommended the InVance Sling from AMS to treat your incontinence. This document will tell you more about incontinence and the InVance Sling-what it is, how it works, and how it is placed in your body. It will also answer some of your questions about living with an InVance Sling.

Getting an InVance Sling is an exciting, life-changing decision. By helping you control your urination, the InVance Sling may help give you back your freedom.

What is bladder control?

We often talk about "bladder control," but in reality, the bladder does not control the flow of urine. The function of the bladder is to collect and store urine.

A circular muscle called the sphincter actually controls the flow of urine out of the bladder. In men, the sphincter is located just below the prostate.

The sphincter wraps around the urethra, which is the small canal that carries urine out of the bladder. A healthy sphincter naturally stays tightly closed most of the time. This muscle squeezes the urethra shut and stops urine from leaking out of the bladder. Keeping the sphincter closed so that urine stays in the bladder does not take any effort.

It does take effort to relax the sphincter. You relax the sphincter when you urinate, or release urine from the bladder. When the sphincter relaxes, the urethra opens and allows urine to move freely from the bladder through the urethra and out of the body.

What is urinary incontinence?

Urinary incontinence is the medical term used to describe the condition whereby you cannot control the flow of urine from your body. It usually happens because the sphincter is damaged or scarred. A damaged sphincter cannot squeeze and close off the urethra.This means urine can leak or flow freely from the bladder.

Many things can prevent the sphincter and bladder from doing their jobs. Most frequently, incontinence occurs in men after total or partial removal of the prostate to treat prostate cancer or other conditions.

Are there different types of urinary incontinence?

There are several types of urinary incontinence:

  1. Stress incontinence occurs when you leak urine during a physical activity like lifting, exercising, sneezing, and coughing.
  2. Urge incontinence occurs when you have an overwhelming need to urinate and are not able to hold urine long enough to reach a toilet.
  3. Mixed incontinence is a combination of stress and urge incontinence and means you have symptoms of both conditions.
  4. Overflow incontinence occurs when your bladder never completely empties, and this causes urine to leak.

The InVance Sling is designed for men who are suffering from stress incontinence.

How do I know what type of urinary incontinence I have?

Talk to your doctor. He or she will ask you about your medical history and urinary habits. It is important that you accurately describe when and under what conditions you have problems controlling your bladder. It may help to keep track of when you urinate, as well as how much fluid you drink or eat, by writing these activities in a voiding diary.

Your doctor will also do a physical examination that may include all or some of the following tests:

Urinalysis - a test that examines the urine for signs of infection, blood, or other abnormalities.

Stress Test - a test that measures the amount of urine loss that occurs when pressure is put on the bladder muscles through common physical activities such as lifting, exercise, and coughing.

Post-void Residual Measurement - a test that measures the amount of urine that remains in the bladder after urination.

Urodynamic Test - a test that examines bladder and sphincter function; it may involve inserting a small tube into the bladder or using X-rays to see the bladder.

Cystoscopy - a test that visually examines the urethra and bladder by insertion of a small tube, called a cystoscope, into the urethra.

How is urinary incontinence treated?

Depending on what type of incontinence you have, you and your doctor can work together to find the best way to cope with your lack of urinary control. It is important that you understand all the options available to you.

You probably have tried several management options already. Chances are, they have not been effective and/or acceptable to you.This is why your doctor has recommended that you receive an InVance Sling.

Symptom Management Options

Symptom management is not a treatment; it is a way of living with your incontinence.

Protective Undergarments: Products such as pads, undergarment liners, and absorbent briefs are worn to absorb urine that has leaked from the bladder.

Behavioral Therapy: Sometimes the bladder can be trained to be more effective in holding urine. Training involves following a strict program whereby you urinate often, on a schedule, and limit how much fluid you drink. Certain exercises may also help strengthen your sphincter.

Condom Catheter: A condom catheter is an external soft latex sheath that is worn over the penis and catches urine as it leaks out of the body. The sheath is attached to a tube that empties into a bag worn on the leg.

External Devices: One device is a clamp that is placed on the shaft of the penis to stop the flow of urine; to urinate, the clamp is removed.

Treatment Options

The options discussed above are for managing the symptoms of incontinence.Treatment options are intended to provide a permanent solution. With effective treatment, most men can resume active lifestyles with dignity.

Medication: A number of medications can help bladder control problems due to urge incontinence. However, no medications have been shown to be effective in treating a weakened sphincter.

Injection: A bulk-producing agent, such as collagen, is injected into the sphincter area to help close off the urethra.This has not been an effective option for most men suffering incontinence following prostatectomy.

Procedures: Two procedures used to treat stress urinary incontinence include the InVance Sling and the AMS Sphincter 800 Urinary Control System. The InVance Sling is designed to support the muscles around the urethra, and is used to treat mild to moderate stress urinary incontinence. The AMS Sphincter 800 Urinary Control System, which mimics the function of a normal, healthy urinary sphincter, is used for more severe stress urinary incontinence.

This document gives you more information about the InVance Sling. You can learn more about the AMS Sphincter 800 Urinary Control System by visiting www.visitAMS.com or by calling 1-800-328-3881.

What is the InVance Sling?

The InVance Sling is an innovative treatment designed to correct mild to moderate stress urinary incontinence in men. A "sling", made of tissue or synthetic graft materials, is placed completely inside your body. The sling creates gentle compression on the urethra for simple, discreet urinary control.

The InVance Sling has proven to be effective in treating mild to moderate stress incontinence. Most patients are continent immediately following the procedure.

How does the InVance Sling work?

The InVance Sling works by gently pressing on the urethra to keep it closed. This constant, gentle pressure eliminates or greatly reduces the possibility of urine leaking, even during strenuous activities such as lifting, exercising, sneezing, and coughing.

Men who have an InVance Sling in place should notice a return to normal urination patterns.

How is the InVance Sling placed inside my body?

Placing the InVance Sling is usually performed as an outpatient procedure, which generally lasts approximately 45 minutes. Local or general anesthesia is used to prevent pain during the procedure.

Before the procedure, your doctor will give you a thorough explanation of what will happen during your hospital stay and how to prepare for it. Your doctor will also explain the procedure in more detail and will describe the associated risks. Be sure to discuss any concerns with your doctor right away. You should also discuss pain with your doctor, so that you know what to expect after the procedure.

In general, placing an InVance Sling involves the following steps (your doctor's method may vary slightly from this one):

  1. The doctor makes a small incision behind the scrotum.
  2. The doctor places several miniature titanium screws into the pubic bone on both sides of the urethra.
  3. The doctor positions the sling so that it places gentle pressure on the urethra.
  4. The doctor secures the sling to the screws in the pubic bone.
  5. The doctor closes the incision.

What can I expect after the procedure?

Your doctor may insert a catheter through your urethra to drain your bladder immediately after the surgery. This catheter is usually removed the same day, or within 24 hours.

Recovery from the surgery is quick, and most men report immediate improvement after the catheter is removed.

Your doctor may prescribe oral antibiotics for a period of time following the procedure to prevent infection. Some slight pain is normal and can usually be treated with oral pain medications. You should contact your doctor if pain persists.

If you notice any redness, swelling, or heat around the incision area, or fluids coming from the incision after the procedure, contact your doctor immediately.

Normal activities can be resumed after a few days, although heavy lifting and strenuous activity should be avoided for a few weeks.

What have studies shown about the effectiveness of the InVance Sling?

Published reports in medical journals have shown that the InVance Sling is a safe and effective treatment option for mild to moderate stress urinary incontinence. After an InVance Sling is placed, most men are dry or experience only minor leaks or dribbles, usually with strenuous exercise or exertion.

By making the decision to have an InVance Sling, you are making a choice shown to improve quality of life. Additionally, placement of an InVance sling does not limit future treatment options, including placement of an AMS Sphincter 800.

What if I still have questions about the InVance Sling?

Below are answers to some of the more frequently asked questions about the InVance Sling. Talk to your doctor or healthcare provider about your specific medical situation and any additional questions you have.

After I have the InVance Sling, will urine still leak?

Like most men, you should stay fairly dry after your InVance Sling is in place. You may find that you have some minor leakage during strenuous activities. This happens because your body exerts pressure on the bladder, especially when you are active. For example, you may have some minor leakage while working in the yard, golfing, bending, or lifting. It is not unusual for some men to wear a light pad to protect against this occasional minor leakage.

Will anyone know that I have an InVance Sling?

Your InVance Sling is placed entirely inside your body. There is nothing visible outside the body. You will urinate "naturally", just as before your incontinence.

Can I participate in sports and other activities that I enjoy?

It is a good idea to discuss all sports and other activities with your doctor before resuming them.Your doctor will tell you when it is appropriate for you to return to physical activities.

How does having the InVance Sling affect sexual activity?

The InVance Sling should not have a negative effect on sexual activity. Many men report that achieving continence actually enhances their sexual activity.

Can I have magnetic resonance imaging (MRI) or go through airport security?

Yes. The InVance Sling is MRI compatible, and the small amount of titanium in the bone screws will not set off airport security alarms.

Will I have to take any precautions before undergoing a medical procedure?

It is important for your healthcare providers to know that you have an InVance Sling before you undergo any medical procedure. Be sure to tell every healthcare provider that you have an InVance Sling before any procedure requiring catheterization. Tell your healthcare provider that use of a small size catheter and use of a flexible cystoscope are recommended.

Will my insurance cover the cost of the InVance Sling?

Medicare and most insurance carriers cover the cost of the InVance Sling. To be sure, verify coverage with your insurance carrier or talk to your doctor.

Where can I get more information about the InVance Sling?

The best resource is your doctor. Your doctor is most familiar with your medical situation and can work with you to make sure you get the best possible results with the InVance Sling. Your doctor can provide you with details on the procedure, its results, and potential complications.

You can also call the AMS patient liaison at 1-800-328-3881, extension 6261. Or, visit their Web site at www.visitAMS.com for more information about the InVance Sling.

InVance Sling Patient Education Brochure 21600050
Courtesy of American Medical Systems, Inc.
Minnetonka, Minnesota
www.AmericanMedicalSystems.com