Artificial Urinary Sphincter (Device)
The AMS 800 (Boston Scientific) is the established hydraulic artificial urinary sphincter (AUS) for male stress urinary incontinence. AUA/GURS/SUFU recommends discussing AUS for mild-to-severe bothersome SUI after prostate treatment, provided the patient can physically and cognitively operate it. A device discussion should include persistent leakage, erosion, infection and future reoperation.[1]
This page covers device construction, handling and evidence interpretation. For implantation, selection, radiation considerations and revision options, see Artificial Urinary Sphincter (procedure).
History and Evolution
Hydraulic AUS implantation began in the early 1970s. The AMS 800 design introduced in the 1980s remains the principal reference platform, with later refinements to tubing, connectors, cuff sizes and antibiotic treatment. Historical failure rates from early small cohorts should not be treated as current device risks.[2]
Design and Components
The three connected components form a closed fluid circuit:[3]
| Component | Function and model details |
|---|---|
| Occlusive cuff | Applies circumferential pressure around the urethra. The cited male IFU lists 13 lengths: 3.5–8 cm in 0.5 cm steps, then 9, 10 and 11 cm. Size is selected from the actual tissue circumference, not a preoperative default. |
| Pressure-regulating balloon (PRB) | Supplies the pressure driving cuff refilling. The cited male IFU lists 51–60, 61–70 and 71–80 cmH₂O ranges. Placement, fill and selection require the actual model's instructions and tissue assessment. |
| Scrotal control pump | The lower bulb moves fluid out of the cuff; the upper valve block contains the resistor, valves and deactivation control. It is not simply a deflate button. |
Mechanism
The patient repeatedly squeezes and releases the pump bulb to move fluid from the cuff into the PRB. The cuff opens for voiding, then refills automatically over several minutes. The required pumping varies; a fixed number of squeezes does not establish that the cuff is empty. Deactivation locks the system after the cuff has been emptied. Pressing the deactivation control while the cuff remains inflated can cause sustained obstruction.[3]
For the teaching sequence and urethral-instrumentation workflow, see System Operation.
InhibiZone and Material Handling
InhibiZone supplies rifampin and minocycline on specified cuff and pump components; the PRB is not antibiotic treated. It does not replace perioperative infection prevention. Check tetracycline/rifampin hypersensitivity and the labeled systemic-lupus contraindication. Treated components must not be soaked in saline or other solutions; alcohol and other specified solvents can remove the treatment.[3]
The label's voluntary manufacturer registry found fewer infection-related revisions with treated devices, but did not capture infections managed without implant surgery and lacked a mechanism to remove deaths or losses to follow-up. This is not randomized proof of a universal reduction in all AUS infections; penile-implant coating results also should not be transferred directly to AUS.[3]
Indications and Preoperative Assessment
The cited US male IFU covers incontinence from intrinsic sphincter deficiency following prostate surgery. Female bladder-neck and pediatric/neurogenic implantation require specialist selection and jurisdiction-specific labeling; they should not be presented as the same indication or evidence population.[3][4][5]
Confirm the leakage mechanism, assess bladder storage/emptying and evaluate urethral or bladder-neck pathology. The Asia-Pacific consensus recommends cystoscopy with or without multichannel urodynamics; it does not make urodynamics mandatory for every candidate. Dexterity and cognitive assessment must anticipate continued use over time.[6][1]
Active infection, unresolved outlet obstruction, unsafe/uncontrolled bladder dysfunction or inability to use the pump require resolution or an alternative plan. Prior radiotherapy increases concern for compromised tissue and erosion, but is not an automatic exclusion: AUA/GURS/SUFU favors AUS over male slings or balloons when post-treatment SUI occurs after radiotherapy. A small historical female series does not establish a universal absolute radiation contraindication for all women.[3][1]
Outcomes and Device Survival
AUSCO Prospective Study
AUSCO enrolled 115 men at 17 sites in a prospective, single-arm study. At 12 months after activation, 91/97 with pad-weight data achieved at least a 50% reduction; 61/101 reported no pad use. Nine of 115 underwent revision, with none attributed to device infection. The full report separately records three postoperative wound infections that resolved without erosion or explantation. Available-case denominators, the absence of a randomized comparator, high-volume centers and one-year follow-up limit extrapolation. See the procedure evidence summary.[7]
Pooled Continence Estimates
A 2023 synthesis of 19 studies/1,271 patients estimated approximately 52% pad-free and 82% using 0–1 pad/day. Most evidence came from cohorts and heterogeneity remained substantial. These different outcome definitions must not be combined into a single “dry rate” or used as a guaranteed individual result.[8]
Long-Term Reintervention-Free Survival
| Cohort | Population and endpoint | Results |
|---|---|---|
| French national study, 2025 | 8,475 first implants; median follow-up 6 years; replacement/removal-free survival | 71% at 2 years, 57% at 5 years, 40% at 10 years. Removal-free survival at 10 years was 66%—a different endpoint. |
| Mayo cohort, 2015 | 1,082 primary implants; median follow-up 4.1 years; freedom from any secondary surgery | 74% at 5 years, 57% at 10 years and 41% at 15 years. |
These observational estimates reflect different settings and definitions, not a head-to-head ranking of centers or a device expiration date. An AUS is not intended to be a lifetime implant.[9][10][3]
Comparative Trials
MASTER randomized 380 men to a transobturator sling or AUS. Sling met the prespecified 15-percentage-point noninferiority margin for the strict patient-reported incontinence outcome at 12 months; most participants in both groups still reported some leakage. Symptoms and satisfaction improved, while statistically significant secondary differences favored AUS. Noninferiority on that endpoint does not establish identical dryness, patient experience or suitability for severe/radiated cases.[11]
Complications — Device-Level Overview
- Infection, erosion and tissue compromise: assess promptly; they may require explantation. Risk varies with tissue quality, prior urethral procedures, radiation and patient comorbidity.
- Mechanical dysfunction: fluid loss, tubing problems, pump malfunction or altered PRB performance can cause recurrent leakage or impaired emptying.
- Recurrent leakage with an apparently functioning device: reassess bladder function, device operation, coaptation and tissue/capsule findings. It is not automatically urethral atrophy or a reason for routine downsizing.
- Urethral instrumentation: completely deflate the cuff and deactivate the device before catheterization or other transurethral passage. Deactivation does not guarantee that every catheter or scope will fit safely.[3]
Prolonged urethral catheterization was associated with erosion in a retrospective cohort; involve the implant team when sustained drainage is needed. No duration threshold makes traumatic instrumentation safe.[12]
Interpreting Revision and Radiation Studies
Bentellis's 1,020-patient revision cohort excluded infection/erosion revisions. Its 56.5% nonmechanical category included recurrent/persistent SUI despite a functioning device, not just atrophy, and was a proportion of the 214 revisions in that selected analysis.[13]
Mann's “fragile urethra” study included 156 men who already had erosion. Its time-to-erosion estimates cannot be presented as population probabilities of remaining erosion-free. Similarly, the 2025 exploratory 1.74-year post-radiotherapy timing signal was not statistically significant and is not a validated minimum waiting interval.[14][15]
Capsulotomy with reassessment and possible same-size cuff replacement is a described revision strategy. The cited expert review does not establish it as the mandatory or superior solution for all nonmechanical failures; choose the revision according to the actual failure mechanism and tissue findings.[16]
Alternative and Emerging Devices
| Device | Distinguishing feature | Evidence boundary |
|---|---|---|
| Victo — Promedon | Preconnected cuff, control pump and separate PRB; pressure adjusted through a port in the pump | It does have a balloon reservoir. A 96-patient cohort provides mid-term outcomes; it does not prove superiority to AMS 800. |
| ZSI 375 — Zephyr | Cuff connected to a scrotal pump/pressure-regulating unit; no separate abdominal reservoir | Selected observational series; their results and exclusions should not be generalized to all high-risk candidates. |
| Electronic AUS, including UroActive | Electronic control and patient remote rather than ordinary manual hydraulic cycling | Clinical investigation has progressed beyond a purely conceptual device. A 2026 six-man first-in-human report provides early feasibility, not established comparative efficacy or long-term durability. |
Confirm country-specific availability, authorization and instructions for the exact device. Device adjustability alone does not establish greater safety or continence.[17][18][19][20][21]
Combined AUS and Penile Prosthesis
Simultaneous or staged implantation may be considered for concurrent SUI and ED. A recent review found encouraging outcomes but included predominantly small retrospective cohorts with inconsistent endpoints and no pooled analysis. Failure to detect more complications in those reports does not prove equal risk for every dual-implant candidate. See Inflatable Penile Prosthesis.[22]
Imaging and Lifelong Device Care
The AMS 800 is MR Conditional, not universally MRI-safe. The cited male IFU permits scanning at 1.5 or 3 T only with its additional scanner, gradient, RF, SAR and duration conditions. MRI staff must identify the implant and apply the corresponding instructions; the field strength alone is insufficient. Other AUS models require their own labeling.[3]
Give the patient the implant identification card, teach deactivation/instrumentation precautions and reassess device function at least annually. New retention, pain, redness, drainage, recurrent leakage or loss of ability to operate the pump warrants earlier review.[3]
Videos
References
1. AUA/GURS/SUFU. Incontinence After Prostate Treatment Guideline, amended 2024, statements 15 and 17–24. Guideline.
2. 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
3. Boston Scientific. AMS 800 Artificial Urinary Sphincter for Male Patients — Instructions for Use. 51266569-01A, English section. Manufacturer IFU. Accessed September 12, 2026; use the IFU supplied with the actual implant.
4. 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
5. 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
6. 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
7. Kaufman MR, Wood HM, Terlecki R, et al. The Artificial Urinary Sphincter Clinical Outcomes Trial: Primary Results. J Urol. 2026;215(2):194-202. Published online October 3, 2025. doi:10.1097/JU.0000000000004796
8. 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
9. 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
10. 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
11. 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
12. 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
13. 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
14. 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
15. 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
16. 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
17. Promedon. Victo adjustable artificial urinary sphincter. Manufacturer device description and safety information. Accessed September 12, 2026.
18. 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
19. 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
20. 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
21. Mozer P, Beaugerie A, Perrouin-Verbe MA, et al. First-in-Human Assessment of the UroActive Electronic Artificial Urinary Sphincter for Treating Male Patients with Stress Urinary Incontinence. J Urol. 2026;216(1):108–117. doi:10.1097/JU.0000000000004945.
22. 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