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AMS 800™ Artificial Urinary Sphincter

Considered the gold standard treatment for male stress urinary incontinence, the AMS 800 Artificial Urinary Sphincter, provides proven, discreet bladder control.1,2

How it works

The AMS 800 System from Boston Scientific is filled with saline and uses the fluid to open and close the cuff surrounding the urethra. When you need to urinate, you squeeze and release the pump in the scrotum several times to remove fluid from the cuff. When the cuff is empty, urine can flow out of the bladder. The cuff automatically refills in a few minutes, squeezing the urethra closed to restore bladder control.

AMS 800™ Artificial Urinary Sphincter

Features of the AMS 800

Restoring quality of life

  • Mimics a healthy sphincter, allowing you to urinate when desired3

  • Offers most men with a weakened sphincter muscle the ability to achieve continence4,5

  • Placed entirely inside the body, it is undetectable to others5

Recommended by patients

  • 94.6% of patients* are satisfied with their device*6
  • 90% of patients are satisfied with their device long-term**7

  • 90% or more would have their surgery again8

  • 96% or more would recommend the device to a friend or family member9

*Non-Urethroplasty patients
**10+ years

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About the procedure

The AUS procedure can be performed on an outpatient basis or may require a short hospital stay. Small openings are made near the scrotum and below the abdomen to insert an inflatable cuff, a pump and a small balloon (pressure regulating balloon). The surgery is performed under anesthesia. Four to six weeks after surgery, you will return to the urologist’s office to have the AUS activated.5

Risks

As with any medical procedure, complications can occur. Requires manual dexterity; some risks include, but are not limited to, device malfunction or failure which may require revision surgery, wearing away/loss of tissue (device/tissue erosion), inability to urinate (urinary retention), infection and postoperative pain.5,10-12

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References

  1. Montague DK. Artificial urinary sphincter: long-term results and patient satisfaction. Adv Urol. 2012;2012:835290.
  2. Biardeau X, Aharony S; AUS Consensus Group, et al. Artificial Urinary Sphincter: Report of the 2015 Consensus Conference. Neurourol Urodyn. 2016 Apr;35 Suppl 2:S8-24.
  3. AMS 800™ Artificial Urinary Sphincter Directions for Use. Boston Scientific. 2019.
  4. Van der Aa F, Drake MJ, Kasyan GR, et al. The artificial urinary sphincter after a quarter of a century: a critical systematic review of its use in male non-neurogenic incontinence. Eur Urol. 2013 Apr;63(4):681-9.
  5. Data on file with Boston Scientific.
  6. Sayedahmed K, Olianas R, Kaftan B, et al. Impact of previous urethroplasty on the outcome after artificial urinary sphincter implantation: a prospective evaluation. World J Urol. 2020 Jan;38(1):183-91.
  7. Léon P, Chartier-Kastler E, Rouprêt M, et al. Long-term functional outcomes after artificial urinary sphincter implantation in men with stress urinary incontinence. BJU Int. 2015 Jun;115(6):951-7.
  8. Viers BR, Linder BJ, Rivera ME, et al. Long-term quality of life and functional outcomes among primary and secondary artificial urinary sphincter implantations in men with stress urinary incontinence. J Urol. 2016 Sep;196(3):838-43.
  9. Linder BJ, Rivera ME, Ziegelmann MJ, et al. Long-term outcomes following artificial urinary sphincter placement: an analysis of 1082 cases at Mayo Clinic. Urology. 2015 Sep;86(3):602-7.
  10. Keles A, Onur R, Aydos M, Dincer M, et al. The Role of Educational Level and Cognitive Status in Men Undergoing Artificial Urinary Sphincter Implantation. Urology. 2021 Jan;147:243‐249.
  11. Ballantyne CC, Sharma D, Rapp DE, et al. Prevalence of Cognitive Impairment and Sphincter Misuse Among Men With Artificial Urinary Sphincters. Urology. 2021 Feb;148:292‐296.
  12. Lavi A, Boone TB, Cohen M, et al. The Patient Beyond the Sphincter‐Cognitive and Functional Considerations Affecting the Natural History of Artificial Urinary Sphincters. Urology. 2020 Mar;137:14‐18.
  13. Bauer RM, Grabbert MT, Klehr B, et al. 36-month data for the AdVance XP male sling: results of a prospective multicentre study. BJU Int. 2017 Apr;119(4):626-30.

Your doctor is your best source for information on the risks and benefits of the AMS 800ᵀᴹ Artificial Urinary Sphincter. Talk to your doctor for a complete listing of risks, warnings and important safety information.

The AMS 800ᵀᴹ Artificial Urinary Sphincter is intended for use in the treatment of male stress urinary incontinence (intrinsic sphincter deficiency) following prostate surgery.

Men with diabetes, spinal cord injuries or skin infections may have an increased risk of infection. Some AMS 800 devices contain an antibiotic (InhibiZoneᵀᴹ Antibiotic Surface Treatment). The device may not be suited for patients who are allergic to the antibiotics contained within the device (rifampin, minocycline or other tetracyclines) or have systemic lupus.

Potential risks may include: device malfunction/failure leading to additional surgery, wearing away/loss of tissue (device/tissue erosion), inability to urinate (urinary retention), infection, and pain/soreness. MH-545611-AB

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.