The AMS 800® Urinary Control System
What is it?
The AMS 800 is a device known as an “artificial urinary sphincter,” which is placed completely inside your body to provide simple, discreet urinary control. You control urination by squeezing and releasing a pump located in the scrotum.
The AMS 800 has proven to be safe and effective in treating moderate to severe male stress incontinence following prostate surgery, and is considered the gold standard by many urologists. When using this device, most men are dry with only minor leaks or dribbles of urine, usually only during strenuous exercise or exertion. Most men use a pad or less per day to manage these minor leaks.
What are the benefits?
Time-Tested: For 40 years, the AMS 800 has been the gold standard for treating incontinence due to intrinsic sphincter deficiency (ISD) following prostate surgery.
Effective: It is capable of offering most men with ISD the opportunity to achieve continence over time.
Long-Lasting: Published clinical data shows long-term results.
How does it work?
The AMS 800 artificial urinary sphincter mimics a healthy sphincter in that it keeps the urethra closed until you want to urinate. It does this by automatically moving fluid through 3 main components: a cuff, a pump, and a balloon. These components are connected by flexible, kink-resistant tubing.
When you need to urinate, you release the pressure on the urethra so that urine can flow. You do this by simply squeezing and releasing the pump located in your scrotum. This action pulls the fluid out of the cuff (which is wrapped around your urethra) and sends it to the balloon. Because the empty cuff is no longer pressing the urethra closed, the urine can flow out of the bladder.
Minutes after the bladder is empty, the fluid automatically returns from the balloon to the cuff. Once the cuff is refilled, the urethra is squeezed closed again.
The AMS 800 is placed during a surgical procedure, usually lasting about an hour and done under general anesthetic. One or 2 small incisions are made near the scrotum and at the abdomen to implant the cuff, balloon, and control pump. Before your surgery, your doctor should give you a thorough explanation of what will happen during the procedure and how to prepare for it. Your doctor should go over the surgical procedure in more detail and will describe the associated risks. Be sure to discuss any concerns with your doctor right away.
In general, placing an AMS 800 involves the following steps (your doctor’s method may vary slightly from this one):
- The doctor makes an incision near the scrotum, performs dissection to the urethra, measures the urethra to determine the right size cuff, and positions the cuff around the urethra.
- The balloon is then placed in the abdomen, and the pump is placed in the scrotum.
- The tubing is connected between the components, and they are filled with a sterile fluid.
- The doctor closes the incision.
Depending on your level of incontinence, your doctor may decide to use 2 cuffs to achieve better success. A second cuff has proven to be successful in providing more control for men with persistent, severe incontinence. You will not notice any difference in device operation if you have 2 cuffs.
What to Expect
Once your AMS 800 is activated, you will be able to control your urination by squeezing the control pump whenever you wish to empty your bladder. It is a good idea to get into the habit of emptying your bladder on a regular basis, such as every 2 to 3 hours.
You may also want to have someone else, such as a spouse, know how to operate the AMS 800 so that they can assist you if it becomes necessary.
Clinical Study Results
Since 1972, more than 150,000 patients throughout the world have received an artificial urinary sphincter. Clinical studies show that the AMS 800 remains an effective treatment option for male urinary incontinence.
In one study of 50 patients, 90% reported satisfaction.3 92% would have the AMS 800™ Urinary Control System placed again.3 Published clinical studies show that 59%-90% used 0-1 pad per day after the procedure.4
3. Montague, DK. Artificial urinary sphincter: long-term results and patient satisfaction. Adv Urol. 2012:835290. doi:10.1155/2012/835290.
4. Kahlon B, Baverstock RJ, Carlson K. Quality of life and patient satisfaction after artificial urinary sphincter. Can Urol Assoc J. 2011;5(4):268-272.
Is It Right for You?
The AMS 800 is a treatment option for men with moderate to severe stress urinary incontinence due to intrinsic sphincter deficiency (ISD) following prostate surgery. Some manual dexterity and strength are required to operate the pump, which controls the device.
If you have any of the following, the AMS 800 may not be right for you:
- Physical or mental conditions that cause poor candidacy for surgical procedures and/or anesthesia
- An irreversibly blocked lower urinary tract
- Irresolvable detrusor hyperreflexia or bladder instability
- Poor manual dexterity
The best way to determine if the AMS 800 Urinary Control System is right for you is to talk with your doctor.
Is it covered?
Medicare and most insurance carriers cover the cost of the AMS 800 Urinary Control System.
Medicare has a National Coverage Determinations (NCD) statement for Incontinence Control Devices (230.10). This NCD states that “such a device is covered when its use is reasonable and necessary for the individual patient.” To be sure, verify coverage with your insurance carrier or talk with your doctor. Please click here to review Medicare patient copay estimates for procedures utilizing AMS products in the outpatient hospital or ambulatory surgical center settings.
If you have questions about your Medicare benefits, you can contact AMS Health Care Affairs toll free with questions at (888) 865-3373 regarding procedures that utilize AMS products. If you have other general questions or need help with your Medicare benefits there is FREE ASSISTANCE AVAILABLE. The State Health Insurance Assistance Program (SHIP) has counselors in every state and several territories who are available to provide FREE one-on-one help with your Medicare questions or problems. Click here to visit Medicare’s Web site to locate a SHIP counselor in your area. Select SHIP from the Search by Organization Name drop-down menu to get started.
For private insurance carriers, AMS recommends that your doctor’s office send a written letter of predetermination to your private insurance company. This letter should ask if you meet the medical necessity requirements for the procedure in addition to verifying your individual policy has coverage for this procedure. Insurance companies typically send back a written response informing you if you meet both requirements.
What are the risks?
The AMS Sphincter 800 Urinary Prosthesis device family is intended to treat urinary incontinence caused by reduced outlet resistance (Intrinsic Sphincter Deficiency) following prostate surgery. The device is contraindicated in patients who are determined to be poor surgical candidates, have an irreversibly blocked lower urinary tract, have irresolvable detrusor hyperreflexia or bladder instability, or (for the AMS 800 with InhibiZone™) have a known sensitivity or allergy to rifampin, minocycline, or other tetracyclines. Patients with urinary tract infections, diabetes, spinal cord injuries, open sores, or regional skin infections may have increased infection risk. Device-skin erosion may occur. Proper patient evaluation, selection, and counseling on realistic expectations should occur. Possible adverse events include, but are not limited to, compromised device function, pain/discomfort, delayed would healing, migration and recurrent incontinence. Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, and potential adverse events. Rx Only.