artificial urinary sphincter

Urinary Continence  

50+ years.* 1,500+ publications. 250.000+ devices sold.*

Designed to help patients achieve continence after one surgery

Boston Scientific is committed to helping physicians improve the lives of patients. With over 50 years of experience in incontinence and over 1500 publications*, AMS 800 has a proven track record as the standard of care for male SUI treatment. With innovative devices that have been proven to help patients regain continence after one surgery and have demonstrated high continence rates and patient satisfaction, physicians are able to provide treatment options beyond absorbent pads, clamps and collection devices.

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Patient Satisfaction

recommend patients percentage

88% of patients surveyed would recommend the AdVance XP™ Sling procedure to a friend.9

patients percentage

In a single survey of 278 male patients, more than 90% reported they would have the surgery again (90% for 1st time implants and 94% for secondary implants).14

patients percentage

One study of 57 male patients found approximately 90% of long-term (more than 10 years) patients are satisfied overall.10

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Featured Male Continence Products

AMS 800™ Artificial Urinary Sphincter

Considered a gold standard for moderate to severe male SUI 5, the AMS 800 Artificial Urinary Sphincter is an effective treatment for SUI in men.

Established outcomes

  • More than 50 years of clinical use, with over 250,000 systems sold worldwide.*
  • Published long-term studies determined that 60-96% of patients that underwent primary and secondary AUS implantation reported using 0-1 pads per day (PPD) following their procedure.**
  • In a study of 105 male patients implanted with an AMS 800™ AUS, 90% of patients with a history of urethroplasty (n=30) and 94.7% of non-urethroplasty patients (n=75) were satisfied with the overall surgical outcome.
artificial urinary sphincter placement

How it works

The AMS 800™ AUS simulates normal sphincter function by opening and closing the urethra, under patient control. When the cuff is closed, urine stays in the bladder.

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AdVance™ XP Male Sling System

More than 80,000 AdVance* and/or AdVance XP Male Slings have been sold worldwide.The AdVance XP Male Sling has been in clinical use for over 10 years and is designed for enhanced ease of use with demonstrated successful clinical outcomes.3

Established outcomes

  • Demonstrated cured and improved rates ranging from 63.2% to 83% at 5 years in patients with mild to moderate incontinence.3,13
male-sling-system-placement

How it works

The AdVance XP Male Sling is placed flat along the corpus spongiosum. The sling is then tensioned, thereby repositioning the bulbous urethra which may result in an increased functional urethral length and a backdrop of support to the distal membranous (sphincteric) urethra during stress events.

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TRANSFORMING LIVES

Discover how the AUS AMS 800™ transformed the life of a patient with Spinal Bifida from incontinence.

In April 2016, Neurourology and Urodynamics published Artificial Urinary Sphincter: Report of the 2015 Consensus Conference.

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In September 2016, The Journal of Urology published Long-Term Quality of Life and Functional Outcomes among Primary and Secondary Artificial Urinary Sphincter Implantations in Men with Stress Urinary Incontinence.

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In April 2013, European Urology published The Artificial Urinary Sphincter After a Quarter of a Century: A Critical, Systematic Review of its Use in Male Non-Neurogenic Incontinence.

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In September 2007, European Urology published Transobturator Sling Suspension for Male Urinary Incontinence Including Post-radical Prostatectomy.

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In May 2014, Urology published Comparison of Clinical Outcomes Between “Ideal” and “Nonideal” Transobturator Male Sling Patients for Treatment of Postprostatectomy Incontinence.

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In January 2021, Urologia Internationalis published Five-Year Results of a Prospective Multicenter Trial: AdVance XP for Postprostatectomy-Incontinence in Patients with Favorable Prognostic Factors

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Boston Scientific Summary of the Five-Year Results of a Prospective Multicenter Trial
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AMS 800™ Product Overview
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Education Resources

For more educational resources, visit EDUCARE, an interactive online resource center which offers healthcare professionals a personalized experience. Access a wide range of content on demand ranging from procedural videos to hands-on training sessions - in one convenient location.

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*50 years and 250,000 sold is inclusive of all AUS devices since 1972.

**Follow-up times vary between studies and groups with the mean/median times ranging between  4 - 6 years.

REFERENCES:

1. 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. 

2. Lucas MD,  Bedretdinova D, Berghmans LC, et al. EAU guidelines on surgical treatment of urinary incontinence. European Association of Urology. March 2015.

3. Mumm J-N, Klehr B, Rodler S, et al. Five-Year Results of a Prospective Multicenter Trial: AdVance XP for Postprostatectomy- Incontinence in Patients with Favorable Prognostic Factors. Urol Int. 2021;105(5-6):421-427

4. Sandhu JS, Breyer B, Comiter C, et al. Incontinence after Prostate Treatment: AUA/SUFU Guideline. J Urol. 2019 Aug;202(2):369-378.

5. 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.

6. Montague DK. Artificial urinary sphincter: long-term results and patient satisfaction. Adv Urol. 2012;2012:835290.

7. James MH, McCammon KA. Artificial urinary sphincter for post-prostatectomy incontinence: a review. Int J Urol. 2014 Jun;21(6):536-43.

8. AMS 800™ Urinary Control System Instructions for Use. American Medical Systems, Inc. 2017 (ERA EL 11)

9. Hüsch T, Kretschmer A, Thomsen F, et al. The AdVance and AdVanceXP male sling in urinary incontinence: is there a difference? World J Urol. 2018 Oct;36(10):1657-1662. (ERA EL 9)

10. Léon P, Chartier-Kastler E, Rouprêt M, et al. Long-term functional outcomes after artificial urinary (ERA EL 10)

11. Boswell TC, Elliott DS, Rangel LJ, et.al. Long-term device survival and quality of life outcomes following artificial urinary sphincter placement. Transl Androl Urol. 2020;9(1):56-61.

12. Cornu JN, Batista Da Costa J, Henry N, et al. Comparative study of AdVance and AdVance XP male slings in a tertiary reference center. Eur Urol. 2014 Feb;65(2):502-4.

13. Rizvi IG, Ravindra P, Pipe M, et al. The AdVance™ male sling: does it stand the test of time? Scand J Urol. 2021 Feb 1:1-6.

14. 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 Sept;163(3):838-43.

The AMS 800™ Artificial Urinary Sphincter is intended to treat urinary incontinence due to reduced urethral/bladder outlet resistance (intrinsic sphincter deficiency) in adult males and females.  Patients with diabetes, spinal cord injuries or skin infections may have an increased risk of infection. Some AMS 800 devices contain an antibiotic (InhibiZone™ 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, but are not limited to: device malfunction/failure leading to incontinence and/or additional surgery, wearing away/loss of tissue (device/tissue erosion), inability to urinate (urinary retention), infection, and pain/soreness. Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, and potential adverse events.

The AdVance™ XP Male Sling System is intended for the treatment of male stress urinary incontinence (SUI). Potential risks may include, but are not limited to, inability to urinate (urinary retention), return to incontinence, infection, erosion, device migration, pelvic organ disfunction, bleeding, and pain. These devices are contraindicated for patients with urinary tract infections, blood coagulation disorders, a compromised immune system or any other condition that would compromise healing, with renal insufficiency, and upper urinary tract relative obstruction. Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, and potential adverse events.

The people featured in the patient testimonial videos were compensated for their travel and/or time.Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.

CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France. All photographs taken by Boston Scientific. All trademarks are the property of their respective owners.

CE 2797 AdVance™ XP Male Sling System and AMS 800™ Artificial Urinary Sphincter