Skip to main content

Artificial Urinary Sphincter (Device)

The artificial urinary sphincter — specifically the AMS 800 (Boston Scientific, formerly American Medical Systems) — has been the gold standard for surgical treatment of moderate-to-severe male stress urinary incontinence for over 50 years and remains the only AUS with extensive long-term worldwide data.[1][2][3][4]

This page covers the device itself. For surgical technique, revision strategies (capsulotomy / same-size replacement, tandem cuff, transcorporal cuff, distal double cuff, downsizing), radiation-tissue considerations, and the special-populations operative literature, see Artificial Urinary Sphincter (procedure).

History & Evolution​

First developed by F. Brantley Scott at Baylor — first implantation 1972.[5][4][6]

  • AS 721 (1972) — single silicone cuff with manually compressed bulb. 82% failure rate (33% erosion).[7]
  • AS 742 (1979) — improved hydraulics; 60% long-term continence; 27% erosion and 13% infection.[7]
  • AS 791/792 — narrow-backed cuff and improved pressure regulation; used through the early 1980s.[8]
  • AMS 800 (1983–present) — the current and definitive model, with three critical innovations:[4][6][9]
    1. Deactivation button — device locked open during postoperative healing.
    2. Narrow-backed cuff — distributes pressure evenly.
    3. Improved pressure-regulating balloon (PRB) — consistent occlusive pressure.

The AMS 800 dramatically reduced mechanical complications — mechanical failure every 16 patient-years vs every 7.6 patient-years with pre-800 models (p = 0.0001).[8] Since 1983 the basic design has not fundamentally changed, though incremental refinements have added InhibiZone (rifampin / minocycline) coating, the Quick-Connect system, and refined cuff sizing.[10][4]

Design & Components​

Three silicone-based components connected by kink-resistant tubing:[1][4][11]

  1. Inflatable urethral cuff — wraps the bulbar urethra (or bladder neck in females / children). Sizes 3.5–11 cm in 0.5-cm increments. Maintains constant occlusive pressure on the urethra.
  2. Pressure-regulating balloon (PRB) — placed in the prevesical space (or ectopic). Pressures: 51–60, 61–70, 71–80, 81–90 cmH₂O. The 61–70 cmH₂O balloon is standard for bulbar cuffs; higher pressures for bladder-neck cuffs.[1][4]
  3. Control pump — scrotal (subdartos pouch) or labial. Deflate button + refill resistor that delays cuff re-inflation 3–5 minutes to allow voiding.

Mechanism​

At rest: the cuff is filled, compressing the urethra closed. To void, the patient squeezes the pump 3–5 times → fluid transfers from cuff to PRB → cuff opens → patient voids. The refill resistor returns fluid to the cuff over 3–5 minutes, restoring continence. The deactivation button locks the device open for catheterization or postoperative healing.[11][1] For the step-by-step patient maneuver (void, deactivate / reactivate) and the catheterization-safety protocol, see System Operation on the AUS procedure page.

Indications​

Primary: moderate-to-severe male SUI after prostatectomy (radical prostatectomy, TURP, simple prostatectomy, HIFU).[1][2][3]

Others:

  • Neurogenic SUI in select patients with acceptable storage parameters — AUA/SUFU Conditional Recommendation, Grade C.[12]
  • Female SUI due to ISD, particularly after failed anti-incontinence surgery; bladder neck cuff placement.[13][14][15]
  • Pediatric neurogenic bladder, exstrophy / epispadias.[8]

Preoperative workup (Asia-Pacific consensus): mandatory cystoscopy to rule out stricture / erosion; urodynamics; pad count + 24-h pad weight; hand-dexterity assessment; optimization of diabetes / BMI.[1]

Contraindications: active UTI, untreated stricture / BNC, inadequate dexterity. Prior radiation is relative (higher erosion risk) but not absolute[16][17] — except in females, where it is essentially absolute (100% removal in one series).[14]

Outcomes & Device Survival​

AUSCO Trial (2025) — First Prospective Multicenter Trial​

n = 115, 17 sites:[2]

  • 94% achieved > 50% pad weight reduction at 12 months.
  • 60% reported zero pad use.
  • 7.8% revision rate at 12 months.
  • Zero infections.

Meta-Analysis (19 studies, n = 1,271)[18]​

  • Complete dry rate ~52%; social continence (0–1 pad/d) ~82%.
  • Pad use ↓ ~4 pads/d.

Long-Term Reintervention-Free Survival​

CohortnFollow-upReintervention-free
France national database[19]8,4756 yr median71% (2 yr), 57% (5 yr), 40% (10 yr); median time to reintervention 6.6 yr
Mayo Clinic[20]1,0824.1 yr median90% (1 yr), 74% (5 yr), 57% (10 yr), 41% (15 yr)
16-center European[21]1,02020 mo median60% (5 yr), 40% (10 yr); nonmechanical failures 56.5% > mechanical 27.6%
Ontario population[22]1,632Long10-yr revision/removal 34%; reimplantation 27%
Long-term French[23]5715 yr medianExplantation-free 87% (5 yr) → 80% (20 yr); 77.2% continent ITT
AUSCO prospective[2]11512 mo92.2%

Women have better mid-term device survival than men (6 mo – 8 yr).[24]

Comparative Trials​

  • MASTER RCT (AUS vs male transobturator sling, n = 380): sling non-inferior for continence at 12 mo; all statistically significant secondary outcomes favored AUS.[25]
  • AUS vs fixed sling for moderate SUI (Sacco propensity-matched): AUS significantly outperformed retrourethral transobturator sling — 0–1 pad/d 94.3% vs 68.6% (p = 0.012).[26]
  • Patient satisfaction consistently > 80%.[2][27][28]

Complications — Device-Level Overview​

For revision strategies and the Hourglass / capsulotomy / same-size-replacement paradigm, see the AUS procedure page.

  • Infection 0.5–10.6% (most series 1–5%); InhibiZone reduces rates; T2DM HR 2.26.[1][27][29][30]
  • Urethral erosion 2.9–12% early / 15% late. Risk factors: prior radiation (HR 2.36–7.57 for replacement devices), prior urethroplasty (HR 2.12), 3.5 cm cuff, prolonged catheterization, "fragile urethra" (1-yr erosion-free 44% vs 77%).[16][30][31][32] Device must be deactivated before any urethral instrumentation.[32][33]
  • Mechanical failure 3–33%; 10-yr freedom ~64%; accounts for 27.6% of revisions.[27][21]
  • Urethral atrophy 1.6–11.4% — the most common cause of nonmechanical failure (56.5% of revisions); modern paradigm prefers capsulotomy + same-size cuff replacement rather than reflex downsizing (see AUS procedure page).[27][21][34]

Radiation Effect​

Single most important risk factor.[16][17][35][36]

  • HR 4.32 for all-cause failure.[17]
  • HR 7.57 for erosion / infection in replacement devices.[16]
  • Optimal post-RT timing: exploratory data suggest waiting > 1.74 yr post-RT may reduce cuff-removal rates.[35]
  • Radiation + prior urethral surgery: 22.4% revision-free survival at 3 yr.[17]

Alternative & Emerging Devices​

DeviceManufacturerDistinguishing featureOutcomes
AMS 800Boston ScientificThree-piece, fixed-pressure PRB52–94% dry / 82–94% social; gold standard
Victo / Victo+PromedonAdjustable pressure via transcutaneous port; no abdominal reservoir[37][38]70–76% social; 83% median pad-weight reduction; 14% device failure, 5% erosion, 5% infection — 3-yr 79% pad-weight reduction maintained, 69–80% satisfaction
ZSI 375ZephyrOne-piece (no abdominal reservoir); adjustable via trans-scrotal injection[39][40]73–93% social; 8.25% erosion; variable across centers (some series 15–62% explantation)
FlowSecureReinhard BeckerAdjustable PRB + stress-relief reservoir (conditional occlusion)Limited clinical data; not widely available
Electronic AUS (eAUS)ConceptualElectronically controlled; no manual pump[10]Under development

The Victo is the most promising alternative — its postoperative pressure adjustability (without reoperation) is a real differentiator. None has displaced the AMS 800 as the reference standard.[10][11]

Combined AUS + IPP​

Simultaneous dual implantation for post-prostatectomy ED + SUI is safe:[41]

  • Social continence 72–100%; IPP satisfaction 84–100%.
  • No increased complication risk vs single-device implantation.
  • See Inflatable Penile Prosthesis for the IPP-side data.

Imaging Considerations​

AUS components are readily identifiable on CT and MRI. MRI is safe at clinical field strengths. See Chorney 2018 and Chung 2026 imaging reviews.[42][43]

See also: Artificial Urinary Sphincter (procedure), Inflatable Penile Prosthesis, Autologous Rectus Fascia.

References​

1. Chung E, Liao L, Kim JH, et al. The Asia-Pacific AMS800 Artificial Urinary Sphincter Consensus Statement. International Journal of Urology. 2023;30(2):128-138. doi:10.1111/iju.15083

2. Kaufman MR, Wood HM, Terlecki R, et al. The Artificial Urinary Sphincter Clinical Outcomes Trial: Primary Results. The Journal of Urology. 2025. doi:10.1097/JU.0000000000004796

3. Suarez OA, McCammon KA. The Artificial Urinary Sphincter in the Management of Incontinence. Urology. 2016;92:14-19. doi:10.1016/j.urology.2016.01.016

4. Chung E. Narrative Review: Evolution in Device Technology and Advances in Surgical Techniques on AMS 800 Device in the Last 50 Years. Translational Andrology and Urology. 2024;13(8):1657-1665. doi:10.21037/tau-23-10

5. Hussain M, Greenwell TJ, Venn SN, Mundy AR. The Current Role of the Artificial Urinary Sphincter for the Treatment of Urinary Incontinence. The Journal of Urology. 2005;174(2):418-424. doi:10.1097/01.ju.0000165345.11199.98

6. Siegel SW. History of the Prosthetic Treatment of Urinary Incontinence. Urologic Clinics of North America. 1989;16(1):99-104.

7. Malloy TR, Wein AJ, Carpiniello VL. Surgical Results With Artificial Urinary Sphincter. Urology. 1982;19(6):602-605. doi:10.1016/0090-4295(82)90008-5

8. Herndon CD, Rink RC, Shaw MB, et al. The Indiana Experience With Artificial Urinary Sphincters in Children and Young Adults. The Journal of Urology. 2003;169(2):650-654. doi:10.1097/01.ju.0000047320.28201.9d

9. Fishman IJ, Shabsigh R, Scott FB. Experience With the Artificial Urinary Sphincter Model AS800 in 148 Patients. The Journal of Urology. 1989;141(2):307-310. doi:10.1016/s0022-5347(17)40748-8

10. Carson CC. Artificial Urinary Sphincter: Current Status and Future Directions. Asian Journal of Andrology. 2020;22(2):154-157. doi:10.4103/aja.aja_5_20

11. James MH, McCammon KA. Artificial Urinary Sphincter for Post-Prostatectomy Incontinence: A Review. International Journal of Urology. 2014;21(6):536-543. doi:10.1111/iju.12392

12. Ginsberg DA, Boone TB, Cameron AP, et al. The AUA/SUFU Guideline on Adult Neurogenic Lower Urinary Tract Dysfunction: Treatment and Follow-Up. The Journal of Urology. 2021;206(5):1106-1113. doi:10.1097/JU.0000000000002239

13. Kobashi KC, Vasavada S, Bloschichak A, et al. Updates to Surgical Treatment of Female Stress Urinary Incontinence (SUI): AUA/SUFU Guideline (2023). The Journal of Urology. 2023;209(6):1091-1098. doi:10.1097/JU.0000000000003435

14. Thomas K, Venn SN, Mundy AR. Outcome of the Artificial Urinary Sphincter in Female Patients. The Journal of Urology. 2002;167(4):1720-1722.

15. Peyronnet B, Capon G, Belas O, et al. Robot-Assisted AMS-800 Artificial Urinary Sphincter Bladder Neck Implantation in Female Patients With Stress Urinary Incontinence. European Urology. 2019;75(1):169-175. doi:10.1016/j.eururo.2018.07.036

16. Huang MM, Huffman P, Dani H, et al. Association Between Previous Pelvic Radiation and All-Cause and Cause-Specific Failure of Replacement Artificial Urinary Sphincters. The Journal of Urology. 2022;207(6):1268-1275. doi:10.1097/JU.0000000000002433

17. Srivastava A, Joice GA, Patel HD, et al. Impact of Adjuvant Radiation on Artificial Urinary Sphincter Durability in Postprostatectomy Patients. Urology. 2018;114:212-217. doi:10.1016/j.urology.2017.12.029

18. Li Y, Li X, Yang Q. Effectiveness of Artificial Urinary Sphincter to Treat Stress Incontinence After Prostatectomy: A Meta-Analysis and Systematic Review. PLoS One. 2023;18(9):e0290949. doi:10.1371/journal.pone.0290949

19. Lenfant L, Taillé Y, Chartier-Kastler E, et al. Artificial Urinary Sphincter Implants in Men: A National Health Care Data System-Based Study to Assess Reinterventions in France. The Journal of Urology. 2025;213(2):217-227. doi:10.1097/JU.0000000000004285

20. Linder BJ, Rivera ME, Ziegelmann MJ, Elliott DS. Long-Term Outcomes Following Artificial Urinary Sphincter Placement: An Analysis of 1082 Cases at Mayo Clinic. Urology. 2015;86(3):602-607. doi:10.1016/j.urology.2015.05.029

21. Bentellis I, El-Akri M, Cornu JN, et al. Prevalence and Risk Factors of Artificial Urinary Sphincter Revision in Nonneurological Male Patients. The Journal of Urology. 2021;206(5):1248-1257. doi:10.1097/JU.0000000000001954

22. Radomski SB, Ruzhynsky V, Wallis CJD, Herschorn S. Complications and Interventions in Patients With an Artificial Urinary Sphincter: Long-Term Results. The Journal of Urology. 2018;200(5):1093-1098. doi:10.1016/j.juro.2018.05.143

23. 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 International. 2015;115(6):951-957. doi:10.1111/bju.12848

24. Cotte J, Dechartres A, Mozer P, et al. Long-Term Device Survival After a First Implantation of AMS800 for Stress Urinary Incontinence: Comparison Between Men and Women. Neurourology and Urodynamics. 2023;42(1):80-89. doi:10.1002/nau.25047

25. Abrams P, Constable LD, Cooper D, et al. Outcomes of a Noninferiority Randomised Controlled Trial of Surgery for Men With Urodynamic Stress Incontinence After Prostate Surgery (MASTER). European Urology. 2021;79(6):812-823. doi:10.1016/j.eururo.2021.01.024

26. Sacco E, Gandi C, Marino F, et al. Artificial Urinary Sphincter Significantly Better Than Fixed Sling for Moderate Post-Prostatectomy Stress Urinary Incontinence: A Propensity Score-Matched Study. BJU International. 2021;127(2):229-237. doi:10.1111/bju.15197

27. Wingate JT, Erickson BA, Murphy G, et al. Multicenter Analysis of Patient Reported Outcomes Following Artificial Urinary Sphincter Placement for Male Stress Urinary Incontinence. The Journal of Urology. 2018;199(3):785-790. doi:10.1016/j.juro.2017.09.089

28. Verbeke L, De Bruyn H, Jamaer C, et al. The Penoscrotal Approach Is a Viable Alternative to the Perineal Approach for Artificial Urinary Sphincter Implantation. International Journal of Impotence Research. 2025. doi:10.1038/s41443-025-01178-4

29. Viers BR, Linder BJ, Rivera ME, et al. The Impact of Diabetes Mellitus and Obesity on Artificial Urinary Sphincter Outcomes in Men. Urology. 2016;98:176-182. doi:10.1016/j.urology.2016.06.038

30. Brant WO, Erickson BA, Elliott SP, et al. Risk Factors for Erosion of Artificial Urinary Sphincters: A Multicenter Prospective Study. Urology. 2014;84(4):934-938. doi:10.1016/j.urology.2014.05.043

31. Mann RA, Kasabwala K, Buckley JC, et al. The "Fragile" Urethra as a Predictor of Early Artificial Urinary Sphincter Erosion. Urology. 2022;169:233-236. doi:10.1016/j.urology.2022.06.023

32. Seideman CA, Zhao LC, Hudak SJ, et al. Is Prolonged Catheterization a Risk Factor for Artificial Urinary Sphincter Cuff Erosion? Urology. 2013;82(4):943-946. doi:10.1016/j.urology.2013.06.044

33. Gaspar CB, Pinto VBP, Junior JB, et al. Preparing Urologists for Urethral Instrumentation in Patients With an Artificial Urinary Sphincter: Results From a Pragmatic, Simulation-Based Intervention. Neurourology and Urodynamics. 2026;45(1):162-168. doi:10.1002/nau.70162

34. Terlecki RP, Wilson SK. A New Paradigm for Surgical Revision of the Artificial Urinary Sphincter for Recurrent Stress Urinary Incontinence: Wilson's Workshop 11. International Journal of Impotence Research. 2022;34(1):37-43. doi:10.1038/s41443-020-0307-8

35. Lee JH, Lee KS, Ko KJ. The Impact of Pelvic Radiation on Artificial Urinary Sphincter Cuff Survival and Optimal Timing for Implantation. World Journal of Urology. 2025;43(1):231. doi:10.1007/s00345-025-05625-1

36. Bochner E, Johnson B, Franzen B, et al. Artificial Urinary Sphincter Placement Before or After Radiation Therapy: Does Timing of Radiation Impact Surgical Complications and Continence? Urology. 2025;197:185-189. doi:10.1016/j.urology.2025.01.003

37. Krhut J, Bartáková L, Kondé A, et al. Outcomes of the Victo Adjustable Artificial Urinary Sphincter in the Treatment of Male Incontinence. BJU International. 2025;135(1):103-109. doi:10.1111/bju.16511

38. Ameli G, Hüsch T, Hübner WA, Weibl P. A New Adjustable Artificial Urinary Sphincter for Male Stress Urinary Incontinence (Victo): Preliminary Clinical Results. Translational Andrology and Urology. 2024;13(8):1546-1554. doi:10.21037/tau-22-779

39. Staerman F, G-Llorens C, Leon P, Leclerc Y. ZSI 375 Artificial Urinary Sphincter for Male Urinary Incontinence: A Preliminary Study. BJU International. 2013;111(4 Pt B):E202-E206. doi:10.1111/j.1464-410X.2012.11468.x

40. Ostrowski I, Golabek T, Ciechan J, et al. Preliminary Outcomes of the European Multicentre Experience With the ZSI 375 Artificial Urinary Sphincter for Treatment of Stress Urinary Incontinence in Men. Central European Journal of Urology. 2019;72(3):263-269. doi:10.5173/ceju.2019.1920

41. Ammirati E, Polisini G, Giammò A. Surgical Treatment Options and Outcomes for Concomitant Treatment of Post-Prostatectomy Erectile Dysfunction and Male Stress Urinary Incontinence: A Systematic Review of the Literature. International Journal of Impotence Research. 2026;38(3):193-205. doi:10.1038/s41443-025-01202-7

42. Chorney ET, Ramchandani P, Jaffe WI, Siegelman ES. CT and MR Imaging Features of Artificial Urinary Sphincters, Penile Prostheses, and Other Devices in the Male Lower Genitourinary Tract. RadioGraphics. 2018;38(3):794-805. doi:10.1148/rg.2018170087

43. Chung AD, Aswani Y, Tsai LL. Imaging Review of Male Genitourinary Devices and Augmentations. European Journal of Radiology. 2026;199:112829. doi:10.1016/j.ejrad.2026.112829