Skip to main content

Artificial Urinary Sphincter (Procedure)

The artificial urinary sphincter (AUS) is the gold standard surgical treatment for moderate-to-severe male stress urinary incontinence (SUI), particularly following prostate surgery.[1][2][3] The AMS 800™ is the predominant device, descended from Scott's 1972 design.[1][5][9] Boston Scientific reports more than 250,000 AUS devices sold across all generations since 1972.[107] It provides durable continence restoration through a completely implantable, fluid-filled hydraulic system that mimics voluntary sphincter function.

Device Components​

The AMS 800 consists of three silicone components connected by kink-resistant tubing forming a closed hydraulic circuit:

AMS 800 components and fluid cycleOriginal schematic · v2026-09-11 · Clinical review pending

A urethral cuff, scrotal pump and pressure-regulating balloon form a closed fluid circuit. Pumping opens the cuff; gradual fluid return closes it. Implant location, pressure selection and handling are device- and patient-specific. (Original WARWIKI schematic; see the figure source record and review limits.)

ComponentLocationFunction
Occlusive CuffBulbous urethra (men) or bladder neckApplies circumferential compression to maintain continence; 13 sizes (3.5–11.0 cm)[6][74]
Pressure-Regulating Balloon (PRB)Prevesical (space of Retzius)Maintains constant system pressure; most common range 61–70 cmH₂O
Control PumpScrotum (men) / labia majora (women)Patient-operated valve mechanism; contains a deactivation button to keep cuff open

The cuff and pump are available with InhibiZone™, a rifampin/minocycline hydrochloride surface treatment intended to reduce colonization; the PRB is not treated. It does not replace perioperative antibiotic prophylaxis. The manufacturer's voluntary implant registry incompletely reports infection-related surgical revisions and excludes infections treated without component surgery; it provides no randomized estimate of infection reduction. For label contraindications and device details, see the AUS device page.[74]

System Operation​

The AUS cycles between continence and voiding by fluid transfer between the cuff and balloon. Patients are trained to operate it at the activation visit and must demonstrate competent cycling before leaving on an active device.[57]

Voiding cycle​

  1. At rest (continent): the cuff is fluid-filled, applying circumferential urethral compression sufficient to prevent leakage.
  2. To void: the patient locates the scrotal pump and squeezes and releases the bulb several times, transferring fluid from the cuff to the PRB. The cuff deflates and the urethra opens.
  3. Auto-refill: the PRB passively returns fluid to the cuff over the next few minutes (1 to 11 minutes in the male operating room manual, depending on cuff and balloon size), restoring continence with no further patient action. A patient with a slow or weak stream may need to deflate the cuff a second time to finish voiding.[74][80]

Deactivation and reactivation​

The control pump has two palpable parts: a soft lower bulb the patient squeezes to pump, and a firmer upper block housing the refill resistor and the deactivation button.[1][57] After the cuff has been emptied, pressing the button as described below prevents refilling. If the valve is closed while the cuff is inflated, the AMS 800 male IFU warns of sustained outlet obstruction and loss of automatic pressure relief; cycling can relieve the obstruction, and the manufacturer's troubleshooting sequence applies if cycling is difficult.[74]

  • To deactivate (AMS 800 male IFU): squeeze and release the pump bulb until the cuff empties and the bulb remains flat. Allow the bulb to partially refill, approximately 30–60 seconds, then press the deactivation button while a slight indentation remains in the pump bulb. The partly filled bulb retains this indentation; the button itself remains palpable in either state. Confirm deactivation before instrumentation.[74]
  • To reactivate: the IFU instructs pressing the deactivation button a few times to loosen the valve poppet, then giving the pump bulb a quick, forceful squeeze. The pump fills first, followed by the cuff over a few minutes. If activation is difficult, use the manufacturer's troubleshooting sequence rather than repeated blind force. Initial activation and training should be supervised.[74]

Deflated is not the same as deactivated. A cuff that has only been pumped down will auto-refill within a few minutes; it stays open only while the deactivation button is engaged. This is the crux of safe catheterization (below); emptying the cuff without deactivating lets it re-pressurize around an indwelling catheter.[57][72]

At the close of surgery the system is filled, cycled to purge air, and left locked open with the cuff empty, not merely deflated, for the healing period.[57][71] Deactivation is then used deliberately in several settings: the postoperative period until activation (see Postoperative Management); before any urethral catheterization or instrumentation; electively overnight in selected patients to decompress the urethra and potentially limit atrophy; and in the obtunded or hospitalized patient who cannot self-cycle.[57][71] In a retrospective two-center comparison of men with incontinence after radical prostatectomy, atrophy-related recurrent incontinence occurred in 10% of 61 men instructed to deactivate the AUS nightly (mean follow-up 40 months) and 21% of 46 men who kept it active (mean follow-up 28 months); the difference was not statistically significant.[93]

At activation, the clinician first confirms the pump sits in the dependent scrotum (teaching the patient to gently "milk" it down if it has ridden up), then activates the device using its instructions and watches the patient cycle it competently. Counsel patients not to forcibly squeeze the pump while it is deactivated, as a hard squeeze can inadvertently reactivate it.[57]

Catheterization and urethral instrumentation in an AUS patient​

A cuff left inflated around a catheter causes pressure necrosis and erosion. Before brief training, 46/135 (34.1%) surveyed urologists and urology residents reported confidence in independently instrumenting an AUS patient in an emergency, underscoring this safety point.[72] Whenever urethral access is needed:[57][72]

  • Deactivate the device first (cuff open) before passing any catheter, cystoscope, or sound; never instrument an active AUS.
  • Use the smallest catheter that will do the job (≤14 Fr) for the shortest possible time.
  • If urethral drainage is likely to exceed 48 hours, obtain urology consultation and consider an image-guided suprapubic tube. For acute postoperative urinary retention persisting seven days, suprapubic drainage is required under the 2015 ICS consensus (Grade D).
  • In the obtunded patient who only needs output monitoring, deactivate and use a condom catheter or pad weights rather than an indwelling urethral catheter.
  • Urology must be consulted whenever an AUS patient needs catheterization, and patients should wear a MedicAlert bracelet / carry a device card so emergency staff deactivate before instrumenting.

Indications​

Primary indications for AUS implantation:[1][2][8]

  • Bothersome SUI of any severity after prostate treatment. The AUA/GURS/SUFU 2024 guideline recommends discussing AUS for mild to severe SUI .[77] In the randomized MASTER trial, a transobturator sling met the trial's noninferiority margin at 24 months for a two-item self-reported ICIQ-UI SF continence composite, not pad-free dryness; symptom scores favored AUS, and further surgery occurred in 20/190 (11%) after sling versus 4/190 (2%) after AUS.[103]
  • Failed conservative management (pelvic floor physiotherapy, behavioral modification). For bothersome SUI despite conservative therapy, the AUA/GURS/SUFU 2024 guideline recommends offering surgery at one year after prostate treatment and permits surgery from six months if leakage is not improving ; most patients with severe SUI show no significant improvement after six months.[77]
  • Intrinsic sphincter deficiency from radical prostatectomy, cryotherapy, HIFU, TURP, or radiation
  • Neurogenic bladder with SUI in select patients with adequate dexterity and acceptable storage parameters (AUA/SUFU NLUTD 2021 Statement 46: may offer; Conditional Recommendation, Grade C)[7][21]
  • Women with severe SUI refractory to other treatments (limited data)[21]

Label contraindications (AMS 800 male IFU): a patient judged a poor candidate for surgery or anesthesia, incontinence due to or complicated by an irreversibly obstructed lower urinary tract, and irresolvable detrusor hyperreflexia or bladder instability. For InhibiZone devices, known allergy or sensitivity to rifampin, minocycline or other tetracyclines, and systemic lupus erythematosus. The IFU lists urinary tract infection, diabetes, spinal cord injury and skin infection near the surgical site as warnings that raise infection risk, and requires adequate manual dexterity, strength, motivation and mental acuity to operate the device. Active infection, urethral erosion and untreated urge incontinence or detrusor overactivity are treated or resolved before implantation.[74]

Preoperative Assessment​

EvaluationPurpose
CystoscopyExclude urethral stricture, bladder neck contracture, bladder pathology, cancer recurrence
UrodynamicsSelective for typical post-prostate-treatment SUI when diagnosis or counseling is uncertain; particularly useful after pelvic radiation or with neurogenic dysfunction to assess detrusor activity, capacity and compliance. Detrusor overactivity and small capacity have not been shown to worsen AUS continence outcomes, but the 2015 consensus advises treating elevated storage pressures and documenting safe pressures before implantation, followed by upper-tract monitoring.[57][74][77]
24-hour pad weightQuantify severity; severe leakage favors AUS over sling (sling studies generally defined severe as >500 g/day or >5 pads/day)[77]
Manual dexterity assessmentPatient must reliably operate scrotal pump
Prostate cancer status, when applicableReview the PSA trend and any planned adjuvant or salvage radiotherapy before choosing AUS timing.[57]
Infection screeningClear any UTI before proceeding

Surgical Technique​

Approaches​

The AUA/GURS/SUFU guideline preferentially recommends a single-cuff perineal approach . In non-randomized comparisons, transverse scrotal placement gave lower dry rates and more short-term explantation (19% versus 9%), and tandem cuffs gave equivalent continence with more explants (17% versus 4% at 48 months); both are reserved for specific situations.[77]

Perineal approach (traditional, most common)

  • Midline perineal incision for cuff dissection around the bulbous urethra
  • Separate small lower abdominal / inguinal incision for PRB placement
  • Optimal visualization; favored for primary implants
  • One described technique exposes about 8 cm of bulbous urethra for a 2-cm cuff, rotates the urethra to each side, and releases its posterior attachments sharply under direct vision; limited exposure followed by blind spreading of a right-angle clamp behind the urethra has been described as risking a posterior-wall tear and early cuff erosion.[86]
  • A single-perineal-incision variant has been described in 6 men (3 with a simultaneous inflatable penile prosthesis): the PRB was placed in a high submuscular ectopic position and the pump in a subdartos pouch through the perineal incision, a pump location also checked in a cadaveric model. At mean 13.9-month follow-up, 4 of 6 used ≤1 pad daily, one required downsizing to a 3.5 cm cuff, one was lost to follow-up, and no perioperative complications were identified.[96]

Transverse scrotal / penoscrotal approach[10]

  • Single-incision access to the proximal bulbar urethra. Wilson and colleagues (2003) described placing all components through one upper transverse scrotal incision in 37 men (25 primary implants, 12 reimplantations after infection or erosion); 66% were completely dry and the rest used 1 pad, and complication rates at 1 year did not differ from the two-incision technique[97]
  • In a retrospective 156-man penoscrotal series, mean operative time was 28.3 ± 8.7 minutes; the study had no perineal comparator.[10] The AMS patient-information-form database (n = 27,096) associated the penoscrotal route with higher explantation and revision rates.[45] Two smaller retrospective comparisons summarized in the narrative review found no significant infection difference between routes; one found similar continence with more revision or replacement after the perineal route, and the other a higher overall complication rate with the perineal route (44% versus 26.3%). Confounding limits both.[16]
  • A 2025 meta-analysis of six observational studies (595 men) found similar dry rates, social continence and complications; the penoscrotal route saved about 33 minutes, and the perineal route was associated with larger cuffs[76]

Bladder neck placement[21]

  • Used primarily in women and children, or men with bulbar urethral compromise
  • Open bladder-neck placement uses a suprapubic incision; robot-assisted laparoscopic placement has been described in six neurogenic men.[79][89]

Transalbugineal approach (emerging)[11]

  • Cuff passed through the tunica albuginea of the corpora cavernosa
  • Sacco and colleagues described preserving an outer corporal tunica layer behind the urethra without entering the corpora cavernosa. In their uncontrolled 47-man series at median 60-month follow-up, three cuff erosions occurred, one noniatrogenic; IIEF-5 scores remained unchanged among preoperatively potent men. Comparative erosion protection remains unknown.[11]

Positioning and Room Setup​

For a perineal cuff, the operating room manual specifies the lithotomy position; for a transverse scrotal approach or bladder-neck placement through an abdominal incision, it specifies supine with the legs gently abducted on arm boards, which still places tension on the urethra similar to lithotomy. Equipment includes Hegar dilators, an Asepto syringe, antibiotic irrigation solution, a urethral catheter, and an optional Penrose drain and rectal tube.[80]

Key Principles​

  • Cuff placed around bulbous urethra in the majority of men; size typically 3.5–6.0 cm (the current IFU states that a 4.0–4.5 cm cuff is typically required at the bulbous urethra; the earlier male operating room manual gives 3.5–4.5 cm). Orient the inflatable surface toward the urethra and mesh backing outward; select the lowest PRB pressure range that maintains closure.[74] The cuff sizer gives only an approximate urethral circumference, and urethral tissue thickness affects sizing[74][79][80]. An older description favored choosing the larger of two candidate sizes whenever the measured circumference fell between them, reasoning that an overly tight cuff could constrict the urethra and contribute to atrophy; this categorical preference is in tension with the retrospective association above between larger initial cuff size and overall revision, and neither source establishes a borderline-sizing rule.[17][86]
  • A urethral catheter or sound identifies the urethra during dissection and is removed before cuff sizing. After cycling and deactivating the device, the male IFU directs insertion of a urethral catheter before closure, with removal timing at the surgeon's discretion.[74][79][80] A Penrose drain may substitute for the cuff sizer during measurement.[74][79][80]
  • PRB placed in the space of Retzius (prevesical space); one described check after perforating the transversalis fascia is to confirm true retropubic placement by palpating behind the pubic symphysis and over the empty bladder, since a balloon trapped between fascial layers may not expand freely when filled, producing more pressure than intended and potentially contributing to cuff erosion.[86] For the transverse scrotal approach when radiation or radical surgery has scarred the retroperitoneum, the AMS 800 male IFU describes a pouch beneath rectus abdominis and anterior to transversalis fascia to avoid piercing the fascia.[74]
  • Use meticulous hemostasis and atraumatic handling. Before closure, assess for urethral injury with a leak test or cystourethroscopy as appropriate; after connecting the components, cycle the device under direct vision to confirm coaptation and function, then deactivate it.[57][74]
  • Give perioperative antibiotic prophylaxis according to the local implant protocol; InhibiZone does not replace it. Do not soak treated components or expose them to alcohol, acetone or other nonpolar solvents, which can remove the surface antibiotics; the IFU permits a brief sterile rinse or dip immediately before implantation.[74]
  • Seat the pump in a dependent subdartos pouch with its deactivation button facing outward so it remains palpable. Cycle and deactivate the device at closure; activate it about 4–6 weeks later after healing.[74]
  • Apply the general incontinence-procedure VTE risk framework (age, obesity, prior VTE, malignancy, prolonged operation or immobility) on the VTE Prophylaxis page.

Outcomes​

Continence​

EndpointRateSource
Study-specific continence and patient-reported outcomesDeruyver: 60% social continence at 5 years; Tutolo: 58% dry at mean 32 months; Plata: 80.7% little or no discomfort and 99% would recommend among men retaining a device; Kaiho: improved quality-of-life scores after implantation[13][14][15][19]
Total dryness (0 pads/day)AUSCO: 61/101 (60%) at 12 months; Tutolo: 58% at mean 32 months[12][15]
≥50% pad weight reduction91/97 evaluable participants (94%) at 12 months (AUSCO trial)[12]
Patient satisfaction and recommendationDeruyver: 92% of 158 men with a functional AUS in situ satisfied with current continence; Plata: 99% of device-retaining respondents would recommend; Kaiho: quality-of-life scores improved after implantation[13][14][19]

The prospective, single-arm AUSCO trial implanted 115 men at 17 sites. At 12 months, 91/97 evaluable participants (94%) achieved ≥50% pad-weight reduction, while 61/101 (60%) reported zero pad use. Seventeen of 115 participants (15%) had a serious adverse event, including 10 (8.7%) with a serious device-related event; nine (7.8%) underwent revision, with none attributed to device infection. The Results report three wound infections, all resolving without erosion or explantation. Follow-up was one year after activation.[12]

Institutional volume effect: In the French national cohort, men treated at lower-volume centers had lower reintervention-free survival.[18] The 2026 EAU male LUTS guideline recommends AUS implantation in expert centers .[108]

Complications​

Early​

  • Urinary retention: reported in roughly 8–32% of implants, higher with transcorporal cuff placement.[16] In a single-surgeon series of 117 men, transcorporal cuff placement carried a significantly higher rate of postoperative retention than conventional cuff placement (32% [7/22] versus 8% [4/53] with a ≥4-cm cuff, p = 0.02) and more often required suprapubic tube placement (27% versus 2%, p = 0.007).[87] Short-term drainage uses a small (10–14 Fr) urethral catheter, and prolonged urethral catheterization is avoided because it raises erosion risk. Persistent retention is drained suprapubically for at least a month; if it has not resolved by then, an inappropriately sized cuff may be responsible and revision may be needed.[16]
  • Hematoma / seroma: scrotal hematomas typically appear 1–3 days after surgery. In an 84-man series summarized in the review, perioperative anticoagulation was associated with explantation within 12 months (9 of 31 anticoagulated versus 3 of 53 not anticoagulated). Large or expanding hematomas are evacuated to protect the device.[16]
  • Pump migration or malposition: in the Mayo revision series summarized in the review, pump malposition, tube kinking or similar problems accounted for 11% (44 of 404) of revisions. Relocation is usually straightforward; plain film or fluoroscopy can confirm component position.[16]
  • Wound infection
  • Visceral or major vascular injury can occur during blind prevesical PRB dissection, especially after prior pelvic surgery or radiation. Unrecognized abdominal visceral injury may present with fever, malaise and abdominal pain.[16]

Late (requiring reoperation)​

ComplicationRateSource
Infection (can occur early or late)1–33% across series; first-implant series are summarized below the table[16]
Urethral erosion3–28% across series (about 8% overall)[16]
Mechanical failure (fluid leak, pump failure)Common late cause of reoperation; fluid loss accounted for 83% of mechanical-failure revisions in one retrospective series summarized in the review[16][17]
Recurrent incontinence with a functioning device ("urethral atrophy")Not reliably quantified; whether atrophy is a distinct cause is debated (see below)[16][51]

Infection and erosion often coexist. The AUA/GURS/SUFU guideline calls for explantation with delayed reimplantation ; full-system removal is the conservative course for infection. For cuff erosion without infection, the AMS 800 male IFU describes cuff-only explantation while preserving the pump and PRB during healing.[16][74][77] Cuff erosion requires cystourethroscopy to diagnose, and new hematuria after implantation is investigated for urethral injury or erosion. Erosion risk is higher after radiation, multiple urethral reconstructions, prior device infection, a relatively small cuff and hypogonadism; events peak in the first two years but continue to at least ten years.[16] Cross-sectional imaging can help characterize component position and complications when the presentation is unclear.[4] Risk is substantially higher in radiated patients and those with neurogenic bladder.[20][21] After infection or erosion, delay reimplantation for 3–6 months; the AUA/GURS/SUFU guideline notes that wash-out with immediate replacement has not been consistently reliable, even without purulence.[77] The narrative review notes that salvage (removal of all components, irrigation and same-sitting reimplantation) has been used in selected stable patients, drawing largely on penile prosthesis practice, and is not recommended with sepsis, virulent organisms, extensive cellulitis or tissue necrosis, ketoacidosis at presentation, or early infection after the primary implant; in most infected devices it favors removal, intravenous antibiotics and delayed reimplantation.[16] Long-term series cited in the guideline report device infection from <1% to 5% and cuff erosion from 1% to 10%.[77] In large first-implant series, 29 of 1,283 Mayo primary implants placed with the historical technique (2.3%) were removed for infection, against 1 of 271 (0.4%) with a "minimal-touch" technique; mean follow-up was 7.8 versus 0.7 years, respectively, and the difference in 12-month cumulative incidence was not statistically significant.[111] In the historical-technique primary cohort, 90% of infections occurred within 6 months.[111] A 16-centre retrospective analysis included 892 of 931 collected primary perineal AUS cases in men with non-neurogenic stress incontinence after prostate surgery and at least 1 year of follow-up; infection occurred in 38 (4.2%) and erosion in 60 (6.7%) over a mean follow-up of 32 months.[15] With prior radiation, infection was 10 of 61 (16.3%) versus 2 of 61 (3.2%) without in one bulbar-cuff series (p = 0.018),[112] and 9.5% versus 5.8% (p = 0.148) in a 13-centre French cohort of 1,277 men.[113] The guideline also cites device (mechanical-component, fluid-loss) failure of about 24% at 5 years and 50% at 10 years; these two figures come from different cohorts and measure mechanical failure only, a narrower endpoint than the all-cause revision-free survival below.[77]

Revision and Long-Term Durability​

Revision burden is a necessary counseling point. In the French national cohort of 8,475 men, 40% were free of AUS replacement or removal at 10 years (median follow-up 6 years).[18] This endpoint differs from all-cause reoperation in the Mayo cohorts discussed below.[16] Single-center Mayo cohorts summarized in Frazier et al.'s narrative review reported surgery-free survival of 90%, 74%, 57% and 41% at 1, 5, 10 and 15 years (median follow-up about 4 years); the larger updated cohort reported 72%, 56%, 41% and 33% at 5, 10, 15 and 20 years (median follow-up almost 5.5 years).[16]

The table separates population-level reoperation-free survival from single high-volume-center results.

TimepointPopulation-level cohort (Lenfant, France, n = 8,475, all-cause reintervention)[18]High-volume Mayo referral center (all-cause reoperation)[16]
1 yearnot reported~90%
2 years71%not reported
5 years57%72–74%
10 years40%56–57%

Median time to first reintervention (replacement or removal): 6.6 years (Lenfant et al.[18], J Urol 2025).

Causes of revision​

Bentellis et al. retrospectively studied 1,020 nonneurological men and excluded revisions/explantations for infection or erosion. Among 214 included revisions, 121 (56.5%) were nonmechanical, 59 (27.6%) mechanical and 34 (15.9%) other causes.[17] Nonmechanical failure included persistent/recurrent SUI with an apparently functioning device.[17]

In a separate mechanical-failure cohort, Linder et al. identified 125 malfunctions among 1,082 primary placements. The failed component was the cuff in 46.1%, reservoir in 22.6%, tubing in 21.7% and pump in 9.6%.[23]

Risk factors for earlier revision[17][20][22]​

Risk factorImpact
Pelvic radiationEarlier complications, higher erosion rates. In a multi-institutional cohort of men undergoing a second (redo) AUS after a prior device complication, 5-yr revision-free survival was 83% with no additional risk factors, 73% with prior radiation alone, 64% with prior urethroplasty alone, and 46% with both radiation and urethroplasty[20]. In a single-surgeon series of 100 men with a 3.5 cm cuff, erosion occurred in 11 of 52 irradiated men (21%) and 2 of 48 nonirradiated men (4%, p = 0.01); radiation was the only significant risk factor for 3.5 cm cuff erosion (OR 6.2, 95% CI 1.3–29.5)[95]
Larger initial cuff sizeOnly independent predictor of overall revision (HR 1.04, p = 0.01) and NOMECA revision (HR 1.05, p = 0.004) in the retrospective Bentellis cohort, which excluded infection/erosion revisions.[17]
Prior AUS explantation for erosion or infectionIn a single-surgeon comparison, secondary reimplantation had future cuff erosion in 14.3% versus 3.6% after a first implant (RR 4.02, p = 0.02)[36]
Childhood posterior urethral distraction injuryIn a small series of 5 patients with combined traumatic posterior urethral disruption and bladder neck incompetence in childhood, delayed bladder neck AUS placement after urethroplasty achieved initial continence in all 5, but the device later eroded (into the bladder neck in 4, into the bladder neck and rectum in 1) at a mean of 3 years (range 6 months to 8 years); the authors favored a catheterizable stoma over AUS in this population[85]
High comorbidity burdenAssociated with increased risk of removal or revision in a 1,632-man population cohort[109]
Diabetes / higher ASA classThe AMS 800 IFU warns of increased prosthetic infection risk with diabetes; in a retrospective cohort of 506 AUS recipients, higher ASA class was associated with explantation on univariate analysis (p = 0.039).[74][110]
Low institutional volumeFewer center implants were associated with lower reintervention-free survival in the French national cohort[18]; surgeon volume was not an independent predictor of device explantation or component revision in the AMS patient-information-form database[45]

Revision and Salvage Techniques​

Preoperative Evaluation​

Before any revision, a systematic workup is needed:[25]

  • Physical examination and interview for signs of infection (scrotal erythema, purulence, pain)
  • Cystoscopy to assess for urethral erosion
  • Device function assessment (pump cycling, fluid status)
  • If infection or erosion is present, perform explantation and delay reimplantation ; full-system removal is the conservative course for infection.[77] For cuff erosion without infection, the AMS 800 male IFU permits cuff-only removal with pump and PRB retained during healing.[74]
  • If no infection or erosion, simultaneous device removal and reimplantation can be performed

Capsular Constriction, Balloon Aging and the Atrophy Question​

A constricted or "hourglass" appearance beneath an explanted cuff can reflect periurethral capsule formation. In Bugeja et al.'s uncontrolled exploration series, 19 of 50 patients had no identified cause beyond low leak-point/closure pressures. In six patients whose restrictive sheath was excised, urethral circumference increased immediately; tested explanted PRBs showed pressure loss. Replacement with a same-size cuff and same-pressure PRB succeeded in 12 of 14 patients from that 19-patient subgroup. The six capsule-release observations and 14 replacement outcomes are different denominators.[51]

Terlecki and Wilson's narrative expert review discusses capsule release, remeasurement and device replacement as an alternative to reflexive downsizing. These observations support evaluating capsular constriction and PRB aging without excluding tissue atrophy as a cause of recurrent incontinence.[52][53]

Operative application: consider careful capsulotomy/capsulectomy in selected revisions when a constrictive capsule is present and tissue can be protected. Reassess urethral circumference after release when performed. Choose cuff size, cuff location and component replacement from the actual tissue and device findings; neither routine capsule excision nor automatic same-size replacement has proven superiority for every nonmechanical failure.[51][52]

1. Cuff Downsizing​

Replacing the existing cuff with a smaller one to improve urethral coaptation in the setting of presumed urethral atrophy, which is the most common NOMECA revision (approximately 69% of NOMECA revisions in the largest multicenter series).[22]

  • Continence outcomes (Krughoff 2023): 97% subjective improvement, 93% decreased pad use, mean −2.2 ± 1.45 pads/day (p < 0.01).[40]
  • Durability: at median 1.8-yr follow-up, 70.6% of downsized cuffs remained in place; 11.8% removed for erosion, 5.9% replaced for mechanical failure, 5.9% for herniated PRB.[40]
  • Pad reduction (Saffarian 2003): in the original downsizing series for sub-cuff atrophy, pad use fell from 3.9 to 0.5 per day with 80% satisfaction.[41]
  • Erosion tradeoff: a smaller cuff can improve continence but is associated with a higher risk of erosion.[16]
  • Tradeoff: downsizing carries a higher rate of subsequent mechanical failure versus other revision techniques (p = 0.01), hypothesized to reflect increased cuff-to-urethra pressure with a tighter cuff.[27]
  • 3.5 cm cuff era: in an institutional before-and-after cohort, 10/45 (22.2%) men initially receiving 4.0 cm cuffs in 2007–2009 required downsizing for persistent incontinence versus 2/43 (4.7%) initially receiving 4.0 cm cuffs in 2010–2013 who required revision (p < 0.001).[26]

Capsule release and same-size replacement are alternatives to downsizing in selected patients; comparative evidence is limited.[51][52]

2. Cuff Repositioning (Relocation)​

Moving the cuff to a more proximal or distal site on the bulbar urethra. Appropriate when the original site shows unhealthy tissue.

  • Better 3-month complete continence than cuff downsizing in the multicenter NOMECA study (p = 0.04).[22]
  • Proximal repositioning (Couillard / Stone, 1995): 5/6 (83%) significantly improved at > 1 yr; the single failure had poor detrusor compliance on preoperative UDS in addition to sphincter weakness.[42]
  • Tradeoff: repositioning with the same cuff size alone is associated with a higher rate of persistent incontinence (p = 0.02); the benefit appears to depend on appropriate re-measurement / sizing at the new site.[27]

3. Tandem Cuff Placement​

Adding a second cuff to increase the coaptive length of the urethra. The IFU states that two cuffs may be placed around the bulbous urethra in men, joined to the system by the Y connector (long branch to the pump), and that only listed cuff-size combinations are usable. For double-cuff placement, the cuffs are separated by 1–2 cm to prevent rubbing and preserve vascularity. Boston Scientific's AMS 800 operating room manual directs an initial 24 mL PRB fill for a new double-cuff system, followed by aspiration and a 20 mL refill after the cuffs pressurize; when adding a cuff while preserving the original cuff, it directs adding 1–2 mL to the new cuff according to cuff size.[79] It also describes a cuff-pressurization option for larger cuffs.[80] The manual notes that both cuffs take about twice as long to refill as one, and that a distal second cuff lies where the spongiosum is thinner, which raises the chance of erosion.[74][80]

  • Brito / Mulcahy 1993: an early double-cuff AMS 800 series added a second cuff around the bulbous urethra in 15 men with severe stress incontinence who had remained significantly wet with the device; 80% became satisfactorily dry.[94]
  • Lowest rate of recurrent incontinence among revision techniques (Eswara multicenter; p = 0.02).[27]
  • DiMarco / Elliott series of 18 patients: pad use 4.3 ± 0.35 to 1.6 ± 0.42 per day (p < 0.001); reoperations for cuff leakage (1) and cuff erosion (2, one with 3 prior revisions including a high-pressure balloon).[28]
  • Single versus double cuff at primary placement (O'Connor 2008): no significant difference in continence, dry rate, or QoL (IIQ-7 14.8 to 4.1 single-cuff versus 16.3 to 6.4 double-cuff, p = 0.34), but double-cuff patients underwent 12 additional surgeries for complications versus 7 for single-cuff.[43]
  • Cadaver model (Manka / Wright): tandem cuff did not significantly improve retrograde leak point pressure versus a single cuff (73.5 versus 77.75 versus 79.25 cm H₂O for distal, proximal, and tandem, p = 0.44); the perceived benefit of tandem cuffs may reflect the more proximal placement of one cuff rather than the dual-cuff mechanism itself.[44]
  • AMS PIF database (n = 27,096): tandem cuff (8.2% of cases) was associated with higher explantation on multivariate analysis, likely reflecting selection bias toward higher-risk patients.[45]
  • Ahyai 2016 prospectively compared 57 low-risk single-cuff versus 123 high-risk double-cuff: no significant difference in pad usage or objective continence, but double-cuff patients reported superior subjective / social continence and less persistent UI (p ≤ 0.02), at a cost of 5.7× higher late explantation risk (p = 0.02) and shorter explantation-free survival (p = 0.003), again confounded by underlying risk.[46]

Tandem cuffs can be placed in standard or transcorporal fashion.[29]

4. Transcorporal (TC) Cuff Placement​

The cuff is placed through incisions in the corporal tunica albuginea, incorporating corporal tissue into the cuff circumference.[30]

  • Adds bulk to the urethra; allows better cuff sizing at distal sites where the urethra is small.
  • Avoids direct dorsal urethral dissection and adds corporal tissue as a buttress; a 2026 meta-analysis of nonrandomized comparisons found lower erosion odds, but causal protection for an individual patient remains unestablished.[30][47][77]
  • Particularly useful after prior erosion, urethral atrophy, or when strong periurethral adhesions preclude safe standard dissection.[25]
  • Counsel potent men about possible erectile-function deterioration after transcorporal cuff placement.[30] In one transcorporal series summarized by Frazier et al., 6 of 12 men with normal preoperative erections (50%) retained erections after surgery.[16][115]

Systematic review and meta-analysis (Domínguez Gutiérrez 2026, 20 studies; comparative studies pooled): TC versus standard showed:[47]

OutcomeTC vs standard
Revision rateHigher (OR 2.99, 95% CI 1.16–7.75)
Explantation rateNo significant difference (OR 1.41, 0.27–7.24)
InfectionLower (OR 0.33, 0.12–0.95)
ErosionLower (OR 0.35, 0.15–0.81)
Continence / QoLComparable

Series:

  • Guralnick / Webster (n = 31, mean follow-up 17 mo): 84% achieved 0–1 pads/day; no erosion or infection in transcorporally placed cuffs.[30]
  • Wiedemann 2013 (n = 23, median 20 mo): 8/17 (47%) perfectly dry, 5/17 (29%) social continence at < 1 pad, improvement in QoL.[48]
  • Ortiz "erosion heat map" 2020: erosion in 18.3% of TC versus 6.1% of standard cases (p < 0.05) in the heat-mapped cohort — anatomic distribution of erosion is similar between approaches.[49]
  • Mock 2015 (n = 37 TC): overall explantation 18.9%; ≥ 2 urethral risk factors were associated with 1.65× higher erosion probability (95% CI 1.3–2.2); 35-mo erosion-free survival 100% with 0–1 risk factors versus 64% with ≥ 2 (p < 0.001); all 4 erosion cases had prior radiation.[50]
  • Moser 2018 (reimplantation after prior erosion, n = 34; 24 transcorporal): recurrent complication 32.4%, recurrent erosion 26.4%.[31] No significant difference versus non-TC group (p = 0.438), but irradiated TC patients had significantly higher repeat-complication rate (p = 0.006).[31]

5. Tandem Transcorporal Cuff​

A tandem transcorporal salvage adds a distal second cuff, with one or both cuffs placed through corporal tunica albuginea to provide dorsal tissue bulk.[29][30] Magera / Elliott series (n = 18, median follow-up 26 mo): median pad use fell from 5.0 to 2.0 (p < 0.001); after two devices were explanted (one erosion, one infection) and excluded from pad-use analysis, 11/16 (69%) used ≤2 pads/day.[29] Four of five patients with little or no improvement were receiving androgen-deprivation therapy; the authors described this as a salvage technique for patients with prior AUS failure.[29]

6. Distal Double Cuff vs Transcorporal — Comparative Outcomes​

Maurer 2019 prospectively compared 58 distal-double-cuff (DC) versus 13 TC patients (all high-risk salvage cases, median 24 mo follow-up):[39]

DCTCp
Objective continence88%72%0.37
Social continence94%100%1.0
Explantation-free survival——0.399

No significant differences in infection, erosion, mechanical failure, or explantation. The authors proposed a sequential salvage strategy: DC first, then TC if DC fails, maximizing total duration of AUS-based therapy across the patient's lifetime.

7. Pressure-Regulating Balloon (PRB) Modification​

Exchanging the PRB for a higher-pressure balloon (e.g., 71–80 cm H₂O instead of 61–70 cm H₂O) or adding fluid to the system. Listed by the 6th International Consultation on Incontinence as an option for recurrent SUI due to atrophy.[32]

  • PRB herniation through the external inguinal ring is a correctable cause of AUS malfunction: in one surgical database, 23/725 patients (3.2%) had symptomatic herniation requiring isolated PRB replacement.[54]
  • Loh-Doyle 2020 identified predictors of device-related complications after exchange to a 71–80 cmH₂O balloon (n = 55): over a median 26.4 months of follow-up, 21/55 (38.1%) required operative repair or removal (erosion 4/55 [7.3%]). Higher BMI predicted mechanical failure, while hypertension and lower BMI predicted erosion; radiotherapy was not a predictor in this cohort.[55]

Higher-pressure balloons require careful assessment of tissue quality and erosion risk. An expert revision review describes capsule release, component exchange and complete replacement as individualized options.[52][55]

Connectors and filling solution in revision. Quick Connect window connectors are not used on previously implanted tubing, because tubing changes over time may make them less effective. Suture-tie connectors (3-0 polypropylene) join old to new tubing, and quick connectors are used only when every prior component is replaced. If radiopaque solution filled the primary device and any primary component is kept, the same solution at the same density is used, since mixing solutions may lose isotonicity or form particles. When a cuff is explanted for erosion and the balloon and pump are not infected, the manual describes plugging the clear tubing with a deactivation-package plug while the urethra heals.[74]

"Drain and retain" the old PRB. When a revision needs a new balloon but the old PRB is densely adherent in the space of Retzius, the existing balloon can be emptied and intentionally left in situ rather than dissected out, sparing a hazardous retropubic dissection near the bladder, iliac vessels, and bowel; a fresh PRB is placed (typically high submuscular or contralateral). Aspirate all fluid, place the tubing on traction, and transect it proximally to defunctionalize the balloon. Cefalu et al. reported infection in 1/55 (1.8%) AUS/IPP drain-and-retain reoperations versus 6/390 (1.5%) initial AUS/IPP implants (p = 0.88), with no statistically significant difference in this observational comparison;[69] a 7-center IPP series (Pereira et al., 2026) found no complications attributable to retained reservoirs at a mean 12.6-month follow-up.[70] The drain-and-retain evidence applies to uninfected devices; infected-device explantation is outside its scope.[69] Retained reservoirs, including an AUS PRB, have caused small-bowel obstruction in case reports, particularly when intraperitoneal; confirm an extraperitoneal position.[100] The full evidence is collated on the penile prosthesis revision-scenarios page.

8. Urethral Wrapping / Tissue Interposition​

Using small intestinal submucosa (SIS) or other biomaterials as a wrap around the urethra before cuff placement to add bulk and serve as a buffer. Trost / Elliott series (n = 8 with multiple prior AUS failures / erosions): 38% completely dry at median 12.4 mo; 37.5% required explantation (2 erosion, 1 infection); prior radiation accounted for 80% of failures; temporary postoperative retention in all. Reserved for the most complex salvage cases; it carries a substantial complication burden in this small series.[33]

9. Complete vs. Partial Device Replacement​

A decision at revision is whether to replace the malfunctioning component or the entire device. Available comparisons are observational and affected by selection and device age:

  • In the multicenter NOMECA cohort, complete change was associated with higher 3-month complete continence (83.3% versus 63.3%, adjusted OR 2.7, 95% CI 1.1–7.1) and longer reported reoperation/explantation-free survival.[22]
  • In Linder's mechanical-failure cohort, three-year device survival was 76% after entire-device replacement versus 60% after single-component replacement, but the difference was not statistically significant (p = 0.11); no validated time cutoff favoring one strategy was identified.[23]
  • When a long interval has passed since initial implantation, complete replacement is recommended due to device aging and deterioration[25]

Salvage After Erosion or Infection​

Management of AUS erosion requires a staged approach:[24][25]

Step 1. Explant the eroded cuff/device and assess the urethral defect. The AUA/GURS/SUFU guideline permits catheter drainage alone, in situ urethroplasty, or anastomotic urethroplasty, selected by defect size and tissue quality .[77] In a retrospective comparison of 13 men per group, stricture developed in 5/13 (38%) after in situ repair versus 11/13 (85%) with catheter alone (p = 0.047); later AUS reimplantation occurred in 7/13 (54%) versus 2/13 (15%) (p = 0.04).[34] Urethral reapproximation without formal urethroplasty was associated with increased stricture risk (OR 4.2, p < 0.05).[24][34][77]

Step 2. Delayed reimplantation. In Linder et al.’s cohort reimplanted after erosion or infection, the median interval after explantation was 9 months (IQR 6–13).[35] In a 2026 French national cohort, 454/2,141 men (21%) underwent reimplantation after first-device removal; among those reimplanted, 50% were free of another AUS replacement or removal at 5 years.[104]

July 2026 evidence: patency and wound healing are separate outcomes

Park et al. retrospectively studied 16 men undergoing immediate repair during explantation for erosion. At median 14 months, one developed stricture (15/16 stricture-free), but 7/16 had superficial wound dehiscence requiring secondary closure. Seven underwent another AUS implant; two subsequently required explantation for recurrent infection. This small, uncontrolled series supports considering immediate repair in selected tissue while counseling about substantial wound morbidity. The uncontrolled series provides no comparison of repair strategies.[73]

Outcomes of Salvage Reimplantation​

OutcomeResult
5-year device survival after salvage68% (vs. 76% for primary, p = 0.38)[35]
Future erosion risk vs. virgin cases4× higher (14.3% vs. 3.6%, p = 0.02)[36]
Repeat erosion / re-explantation in salvage cohort38/96 (40%) men who received a salvage AUS after initial erosion[24]
Functioning salvage AUS at last follow-up36% of erosion patients[24]
Restoration of baseline continence at 2nd/3rd revision89%[37]

Salvage Options for Patients Not Candidates for Reimplantation​

For patients with severely compromised urethral tissue who cannot undergo further AUS placement:

  • Permanent urethral ligation (PUL) with suprapubic tube drainage achieved continence in 18/20 (90%) after initial or repeat ligation (15 after initial surgery, 3 after repeat; mean age 75), with 11/20 (55%) experiencing 90-day complications (mostly Clavien-Dindo Grade II–III). At a mean 30.3-month follow-up, 13 of the 15 men still managed by PUL had satisfactory M-ISI scores and reported overall improvement on PGI-I.[38]
  • Bladder neck closure with catheterizable stoma or supravesical diversion remains an option for the most refractory cases.

Sequential Salvage Paradigm​

A proposed sequential approach to maximize the duration of AUS-based incontinence therapy:[30][39]

  1. Primary standard bulbar cuff. If failure occurs:
  2. Distal double cuff or cuff downsizing/relocation. If failure occurs:
  3. Transcorporal cuff placement. If failure occurs:
  4. Permanent urethral ligation or urinary diversion

A prospective, nonrandomized comparison of distal double cuff (DC) versus transcorporal cuff (TC) in salvage settings reported 88% objective and 94% social continence for DC versus 72% objective and 100% social continence for TC (p = 0.37 and p = 1.0, respectively), with similar explantation-free survival (log-rank p = 0.399).[39]

Key Principles of Revision and Salvage​

  • In Raj et al.’s retrospective bulbar-urethral AUS cohort, 5-year device durability was 80% after primary implantation and 88% after secondary implantation; baseline continence was restored in 106 secondary or tertiary revisions (89%), including men with multiple prior revisions.[37]
  • Evaluate capsular constriction, tissue quality and device function in recurrent SUI; capsule release and same-size replacement are selected options supported by small series and expert discussion.[51][52]
  • When capsule release is performed, remeasure afterward and select the cuff from operative findings.[52]
  • Complete versus partial replacement remains individualized.[22][23]
  • Tandem cuff placement yields favorable continence outcomes among revision techniques, but cadaver-model and database data suggest some of the benefit reflects more-proximal placement and selection bias rather than the dual-cuff mechanism itself[27][44][45]
  • Transcorporal cuff placement was associated with lower infection (OR 0.33) and erosion (OR 0.35), but higher revision (OR 2.99), in pooled nonrandomized comparisons; selection and conflicting high-risk cohorts limit causal inference, and erosion remains possible after radiation.[30][31][47]
  • Sequential salvage: one center proposed a distal double cuff followed by transcorporal placement in selected patients; its observational comparison did not test whether this sequence prolongs total AUS therapy.[39]
  • Erosion-site management may use catheter drainage alone, in situ repair, or anastomotic repair according to defect size and tissue quality ; a small retrospective comparison associated in situ repair with fewer strictures and more subsequent reimplants.[34][77]
  • In this retrospective redo cohort, median survival of a second AUS was similar to that of the initial device in radiated and nonradiated men; estimates for third devices were limited by short follow-up. Radiation and prior urethroplasty were associated with lower redo durability. Relative to 4.0-cm cuffs, both 3.5-cm and ≥5.0-cm cuffs had higher explantation hazards in second- and third-device analyses.[20]

Special Populations​

Post-radiation: For men seeking surgery after primary, adjuvant, or salvage radiotherapy, the AUA/GURS/SUFU 2024 guideline recommends offering AUS over male slings or adjustable balloons .[77] AUS remains the guideline-preferred surgical option, but counsel on earlier device failure, reduced durability, and higher erosion risk after radiation.[20][77]

Neurogenic bladder: AUS can be offered to selected patients with adequate upper extremity function; address unsafe bladder storage pressures before implantation (often with antimuscarinic therapy or onabotulinumtoxinA).[7][21] In NLUTD patients whose impaired storage or voiding places the upper tracts at risk, the AUA/SUFU 2021 guideline recommends repeat urodynamics at an appropriate interval after treatment .[7] Bladder-neck placement is the usual approach in this population. For neurogenic men with an intact prostate, periprostatic cuff placement (around the prostate rather than the bladder neck) has been described as a selected alternative at specialized centers, with the rationale that a more proximal cuff may reduce repeated bulbar-cuff trauma from clean intermittent catheterization, perineal pressure injury and infection risk in wheelchair users, and injury during future large-caliber cystoscopic procedures. In a French multicenter retrospective series of 51 men with periprostatic AUS for neurogenic sphincteric incontinence (31% spina bifida, 69% spinal cord injury), mean follow-up was 83 months; 74% had perfect or moderate continence with a working device at 10 years, with 15/51 lost to follow-up.[88] A small feasibility series describes robot-assisted laparoscopic AMS 800 placement around the bladder neck in six men with spinal cord injury: all six devices were functioning with complete continence at a median 13-month follow-up, with a median operating time of 195 minutes and a median hospital stay of 4 days; this is early feasibility evidence without a comparator or long-term outcomes.[89]

Bladder exstrophy-epispadias complex (BEEC): Prior bladder-neck dissection can make cuff placement technically difficult. In a cohort of 23 children without spina bifida who received an AUS after bladder-neck or proximal urethral surgery (12 with bladder exstrophy, 7 with anorectal malformation, 4 with isolated epispadias), 3 of the 12 exstrophy patients (25%) had the device removed for erosion or infection, a higher rate than in the epispadias or anorectal-malformation subgroups; 19 of 22 children with follow-up (86%) retained a device at a mean of 80 months. The small, older cohort provides BEEC subgroup outcomes, without a general success estimate for BEEC or other pediatric or neurogenic AUS recipients.[90]

Concurrent penile prosthesis: In men with incontinence after prostate treatment and erectile dysfunction, concomitant or staged implantation may be offered .[114] Combined surgery lengthens the operation. The comparative literature on added risk is mixed rather than one-directional: a single-center comparison of 248 AUS-only cases and 118 AUS cases with a penile prosthesis (mean 41-month follow-up) found higher first-time cuff erosion among 304 evaluable patients (11/95 [11.6%] versus 9/209 [4.3%]) and higher all-cause AUS explantation (20/118 [17%] versus 23/248 [9.2%]) in the penile-prosthesis group[83], but a larger SEER-Medicare comparison of 793 AUS-only, 644 penile-prosthesis-only and 62 combined-implantation patients (median 61-month follow-up) found no difference in 30- or 90-day complications or long-term device survival with same-date combined implantation.[84] Careful attention to scrotal pump positioning avoids device-on-device interference.[21][77][83][84]

After failed male sling: AUS is recommended for persistent or recurrent SUI after a sling; outcomes of AUS after sling are similar to primary AUS.[77]

Prior urethral reconstruction, stricture surgery or stenting: AUS may be offered with counseling that complication rates are higher (prior urethroplasty raised erosion risk in cohorts cited by the guideline); treat symptomatic bladder neck contracture or anastomotic stenosis before implanting.[77] In a retrospective multicenter cohort of 178 men after urethroplasty, explantation for infection, erosion, or mechanical failure occurred in 56.2% after transecting versus 23.5% after nontransecting repair over median 33.5-month follow-up.[105]

Women: See the dedicated Female AUS (Bladder Neck Placement) section below.

Postoperative Management​

  • Deactivation period: Device remains deactivated for 4–6 weeks (manufacturer IFU) to allow tissue healing around the cuff before first activation. The earlier male operating room manual specified 6–8 weeks after bladder-neck placement. Until activation the patient uses pads or a condom catheter and avoids compression of the cuff area[8][74][80]
  • Activation visit: The clinician confirms wound healing and trains the patient on pump cycling technique. Thereafter, the male IFU calls for at least annual contact to assess device function and any change in performance.[74]
  • Patient ID card: Patients carry a permanent card identifying the implant; emergency staff must be informed; no urethral catheter or instrument should be passed without first deactivating the device
  • MRI compatibility: The current AMS 800 IFU lists the system (InhibiZone-treated and untreated) as MR Conditional at 1.5 T or 3.0 T in a horizontal-bore cylindrical scanner, with a maximum spatial field gradient of 40 T/m, normal operating mode, circularly polarized RF excitation, and whole-body SAR of 2 W/kg for up to 60 minutes of continuous RF; expect an image artifact extending about 36 mm from the device. The MRI table does not list cuff deactivation as a condition. Earlier labeling editions state different limits (1.5 T with a gradient of 450 G/cm or less and SAR 1.5 W/kg; 3 T with 720 G/cm or less and SAR 2.9 W/kg, each for 15 minutes of scanning; another edition states 3 T or less with 720 G/cm or less and SAR 2.9 W/kg). Identify the implanted components and apply the edition supplied with the implant, or the newest labeling, before scanning[74][81][82]

Female AUS (Bladder Neck Placement)​

The AMS 800 in women is placed around the bladder neck, not the bulbar urethra. It is a high-acuity salvage operation for severely compromised outlet function.

Indications​

The 2023 AUA/SUFU guideline (Statement 22) allows an obstructing autologous pubovaginal sling (PVS) or bladder neck closure with urinary drainage for women with severe outlet dysfunction or persistent SUI after failed surgery.[56] Its discussion adds that in more severe cases an AUS, catheterizable bladder neck closure or diversion may be needed, and that the AUS is a viable consideration in the non-index patient after thorough counseling. NICE NG123 restricts AUS to women whose previous surgery has failed.[56][78]

  • Failed prior anti-incontinence surgery. The 2015 ICS Consensus, the 2023 AUA/SUFU guideline discussion and NICE NG123 position AUS as a salvage option in women with persistent SUI after failed surgery; the ICS consensus favors it particularly when residual urethral mobility is absent. Expert consensus recommends referral after a maximum of two prior surgical procedures; erosion and revision risk rises with each additional intervention.[56][57][58]
  • Severe intrinsic sphincter deficiency (ISD). Low urethral closure pressure (or low VLPP), loss of urethral mobility, and a negative Marshall / Bonney test. This is the core pathophysiologic indication.[59]
  • Neurogenic SUI. Neurogenic sphincter deficiency is one of the two settings in which female ISD usually presents; the 26-woman Phé series comprised 23 women with spinal cord injury and 3 with spina bifida.[59][60]

Prior pelvic radiotherapy in women: the 2015 ICS consensus treats it as a contraindication because of infection and erosion risk (Grade D).[57] The 2026 EAU female LUTS guideline classifies prior irradiation as complicated SUI and reports more frequent AUS explantation after radiotherapy; it recommends considering AUS among treatment options and counseling about complication, mechanical-failure and explantation risks .[106]

Surgical Approaches​

Three approaches have been described. The vaginal route is abandoned due to unacceptable infection and erosion rates; consensus favors a retropubic approach without opening the vagina (Grade B).[57]

1. Open Retropubic (Traditional)​

  • Low midline or Pfannenstiel incision; entry into the retropubic (Retzius) space.
  • Circumferential bladder-neck dissection, separating the posterior bladder neck from the anterior vaginal wall, the most technically demanding step, as there is no natural plane between urethra and vagina.[59]
  • Cuff placed around the bladder neck between periurethral fascia and vagina.
  • PRB placed in the retropubic space or between abdominal musculature and transversalis fascia.[57]
  • Control pump positioned in the labia majora.[60]

2. Laparoscopic​

  • Transperitoneal access to the Retzius space; cuff placed around the bladder neck between periurethral fascia and vagina as in the open approach.[61][62]
  • Largest single-center series (n = 74, mean follow-up approximately 45 months): 78% complete continence, 19% improvement, mean operative time approximately 120 min.[61]

3. Robot-Assisted​

Two variants:

  • Anterior approach. Transperitoneal access to the Retzius space; an assistant's vaginal finger guides dissection of the vesicovaginal space.[63][64] One described sequence passes the measuring tape behind the bladder neck and around it to measure circumference, then sutures the free end of the prepared cuff to the posterior end of the tape and uses the tape as a traction aid to guide cuff passage before snapping it into place.[63]
  • Posterior approach. Dissection begins posterior to the bladder neck, potentially avoiding blind anterior dissection and reducing vaginal/bladder injury risk. Some centers add intraoperative cystoscopic monitoring to confirm the correct plane.[65][66]

The largest open-versus-robotic comparison (Dubois 2025; retrospective, n = 135) reported the following associations.[67] Median follow-up was 12.2 months after robotic versus 25.5 months after open implantation, and prior radiation differed (0% versus 6.2%):[67]

OutcomeRoboticOpen
Intraoperative complications12.7%27.4%
Postoperative complications15.5%46.8%
Full continence83.3%62.3%
Explantation (reported events; open-group rate unresolved)1/7122/64 (paper also reports 27.4%)[67]

Device Specifications in Women​

ParameterFemale bladder-neck valueNotes
Cuff sizeMedian 7.0 cm (typical range 6.5–8 cm); 5.5–9 cm in neurogenic seriesSubstantially larger than the male bulbar cuff (3.5–6 cm). The same 13-size cuff family (3.5–11 cm) is used for bladder-neck placement in men, women and children, and the surgeon sizes the cuff with the cuff sizer[60][68][79]
PRB61–70 cmH₂O in most patients; 71–80 cmH₂O at surgeon discretionBladder neck tolerates higher pressure than bulbar urethra[57][68]
PRB fill volumeThe cited bladder-neck manual initially fills the PRB with 22 mL, pressurizes the cuff, then aspirates the PRB and refills it with 20 mL; follow the current device-specific IFU for the chosen components.[79][74]
Pump locationLabia majora (right or left)[60]
Activation4–6 weeks postoperatively[79][65][68]

One described center-specific practice removes the urethral catheter on postoperative day 5, confirming adequate bladder emptying with ultrasound; a patient already performing intermittent self-catheterization before surgery has the catheter removed sooner and resumes her baseline catheterization.[91]

Outcomes​

A meta-analysis of 964 women (15 studies) reported a mean complete continence rate of 80% (95% CI 72–87) at mean 22-month follow-up.[75] A systematic review of 17 case series reported complete continence rates of 61–100% across vaginal, open, laparoscopic, and robotic approaches.[56][59]

Complications:

ComplicationRate (range)MeanSource
Mechanical complications0–47%~13%[75]
Vaginal / urethral erosion0–27%~9%[75]
Infection0–46%~7%[75]
Revision required0–44%~15%[75]
Explantation required0–44%~13%[75]

Long-term durability in neurological women: explantation-free survival 74% at 20 years, though only about half remained free of revision at 10 years (75% at 5 years) in this 26-woman cohort.[60]

Surgical volume and experience may influence outcomes: among open series with mean follow-up over 5 years, the two largest (215 and 344 women) reported the lowest explantation (7% and 12.8%) and mechanical-failure (15.5% and 13.6%) rates.[59] The robotic approach may offer visualization and deep-pelvic-access advantages, potentially reducing morbidity even during the learning curve.[63][67]

Pregnancy after implantation. Childbearing potential alone is not an exclusion to female AUS implantation. The only dedicated report is old and small: of 9 pregnancies among 71 women with a female AUS, 7 occurred with a functioning device in place (2 had the device removed for erosion before conceiving), and all 11 resulting children were delivered normally, with continence otherwise unchanged aside from increased urinary frequency and slight leakage during pregnancy; 4 of the 9 women had a cesarean delivery by obstetric advice, and the rest delivered vaginally without difficulty attributed to the device. Device deactivation is reasonable during the third trimester and through labor and delivery, and cesarean delivery is not mandated by the device's retropubic location.[92]

See Also​

Counseling Summary​

PointDetail
Social continence probabilityPooled 81% (0–1 pad/day) in men after prostate surgery; follow-up varied[101]
Complete dryness probabilityPooled 52% (0 pads/day) in men after prostate surgery; follow-up varied[101]
Reintervention-free survival at 5 years57% after first implantation in a French population cohort (replacement or removal)[18]; overlapping Mayo Clinic cohorts reported 74% and 72% secondary-surgery-free survival[16][98][99]
Secondary-surgery-free survival at 10 years56–57% in overlapping Mayo cohorts after primary male AUS implantation (any secondary surgery)[98][99]
Would choose AUS again92% of 50 surveyed men at median 23.4 months (50 of 65 implanted patients responded)[102]
Device lifespanLong-term implant that may require replacement or removal; the pump must be operated for voiding
Medical precautionMust deactivate before any urethral instrumentation

See Also​

Videos​

Step-by-Step Placement of the Artificial Urinary Sphincter
AUA University (2023)
Artificial Urinary Sphincter: Transcorporal Approach
AUA University (2023)
Robotic AMS 800 Implantation in Women (Transperitoneal Posterior)
Lambert E, et al. Urology Video Journal 2023 (CC BY 4.0)
Open source videoRead the article
Single-Incision Artificial Urinary Sphincter
Liaw A, et al. Urology Video Journal 2023 (CC BY 4.0)
Open source videoRead the article

References​

1. James MH, McCammon KA. Artificial urinary sphincter for post-prostatectomy incontinence: a review. Int J Urol. 2014;21(6):536–43. doi:10.1111/iju.12392. PMID 24528387

2. Suarez OA, McCammon KA. The artificial urinary sphincter in the management of incontinence. Urology. 2016;92:14–9. doi:10.1016/j.urology.2016.01.016. PMID 26845050

3. Silva LA, Andriolo RB, Atallah ÁN, da Silva EM. Surgery for stress urinary incontinence due to presumed sphincter deficiency after prostate surgery. Cochrane Database Syst Rev. 2014;(9):CD008306. PMID 25261861 doi:10.1002/14651858.CD008306.pub3

4. Oda S, Kuno H, Hiyama T, et al. Radiologic feature of complications after artificial urinary sphincter implantation following total prostatectomy. Abdom Radiol. 2024;49(7):2416–27. doi:10.1007/s00261-024-04360-2. PMID 38849538

5. Mohammed A, Khan A, Shaikh T, Shergill IS, Junaid I. The artificial urinary sphincter. Expert Rev Med Devices. 2007;4(4):567–75. doi:10.1586/17434440.4.4.567. PMID 17605692

6. Natali AN, Fontanella CG, Carniel EL. Biomechanical analysis of the interaction phenomena between artificial urinary sphincter and urethral duct. Int J Numer Method Biomed Eng. 2020;36(3):e3308. doi:10.1002/cnm.3308. PMID 31945261

7. Ginsberg DA, Boone TB, Cameron AP, et al. The AUA/SUFU guideline on adult neurogenic lower urinary tract dysfunction: treatment and follow-up. J Urol. 2021;206(5):1106–13. doi:10.1097/ju.0000000000002239. PMID 34495688

8. Chung E, Liao L, Kim JH, et al. The Asia-Pacific AMS800 artificial urinary sphincter consensus statement. Int J Urol. 2023;30(2):128–38. doi:10.1111/iju.15083. PMID 36375037

9. Lee R, Te AE, Kaplan SA, Sandhu JS. Temporal trends in adoption of and indications for the artificial urinary sphincter. J Urol. 2009;181(6):2622–7. doi:10.1016/j.juro.2009.01.113. PMID 19375102

10. 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: a retrospective cohort study. Int J Impot Res. 2025 (online Sept 18). doi:10.1038/s41443-025-01178-4

11. Sacco E, Marino F, Gandi C, et al. Transalbugineal artificial urinary sphincter: a refined implantation technique to improve surgical outcomes. J Clin Med. 2023;12(8):3021. doi:10.3390/jcm12083021. PMID 37109357

12. 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

13. Deruyver Y, Schillebeeckx C, Beels E, De Ridder D, Van der Aa F. Long-term outcomes and patient satisfaction after artificial urinary sphincter implantation. World J Urol. 2022;40(2):497–503. doi:10.1007/s00345-021-03877-1. PMID 34821960

14. Plata M, Zuluaga L, Santander J, et al. Performance of the artificial urinary sphincter implantation in men with urinary incontinence: results from a contemporary long-term real-world nationwide analysis. Neurourol Urodyn. 2022;41(7):1573–81. doi:10.1002/nau.25002. PMID 35866192

15. Tutolo M, Cornu JN, Bauer RM, et al. Efficacy and safety of artificial urinary sphincter (AUS): results of a large multi-institutional cohort of patients with mid-term follow-up. Neurourol Urodyn. 2019;38(2):710–18. doi:10.1002/nau.23901. PMID 30575997

16. Frazier RL, Jones ME, Hofer MD. Artificial urinary sphincter complications: a narrative review. J Clin Med. 2024;13(7):1913. doi:10.3390/jcm13071913. PMID 38610677

17. Bentellis I, El-Akri M, Cornu JN, et al. Prevalence and risk factors of artificial urinary sphincter revision in nonneurological male patients. J Urol. 2021;206(5):1248–57. doi:10.1097/ju.0000000000001954. PMID 34184925

18. 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. J Urol. 2025;213(2):217–27. doi:10.1097/ju.0000000000004285. PMID 39401342

19. Kaiho Y, Masuda H, Takei M, et al. Surgical and patient reported outcomes of artificial urinary sphincter implantation: a multicenter, prospective, observational study. J Urol. 2018;199(1):245–50. doi:10.1016/j.juro.2017.08.077. PMID 28823767

20. Fuller TW, Ballon-Landa E, Gallo K, et al. Outcomes and risk factors of revision and replacement artificial urinary sphincter implantation in radiated and nonradiated cases. J Urol. 2020;204(1):110–14. doi:10.1097/ju.0000000000000749. PMID 31951498

21. Chung E. Artificial urinary sphincter surgery in the special populations: neurological, revision, concurrent penile prosthesis and female stress urinary incontinence groups. Asian J Androl. 2020;22(1):45–50. doi:10.4103/aja.aja_128_19. PMID 31793444

22. Cousin T, Peyronnet B, Bentellis I, et al. Which revision strategy is the best for non-mechanical failure of male artificial urinary sphincter? World J Urol. 2023;41(12):3663–3669. doi:10.1007/s00345-023-04670-y

23. Linder BJ, Viers BR, Ziegelmann MJ, et al. Artificial urinary sphincter mechanical failures — is it better to replace the entire device or just the malfunctioning component? J Urol. 2016;195(5):1523–1528. doi:10.1016/j.juro.2015.10.084

24. Findlay BL, Fadel A, Pence ST, et al. Natural history of artificial urinary sphincter erosion: long-term lower urinary tract outcomes and incontinence management. Urology. 2024;193:204–210. doi:10.1016/j.urology.2024.06.054

25. Kaiho Y, Oikawa M, Kusumoto H, et al. Treatment strategies for revision surgery of artificial urinary sphincter: a review. Int J Urol. 2024;31(12):1312–1320. doi:10.1111/iju.15569

26. Simhan J, Morey AF, Zhao LC, et al. Decreasing need for artificial urinary sphincter revision surgery by precise cuff sizing in men with spongiosal atrophy. J Urol. 2014;192(3):798–803. doi:10.1016/j.juro.2014.03.115

27. Eswara JR, Chan R, Vetter JM, et al. Revision techniques after artificial urinary sphincter failure in men: results from a multicenter study. Urology. 2015;86(1):176–80. doi:10.1016/j.urology.2015.04.023

28. DiMarco DS, Elliott DS. Tandem cuff artificial urinary sphincter as a salvage procedure following failed primary sphincter placement for the treatment of post-prostatectomy incontinence. J Urol. 2003;170(4 Pt 1):1252–4. doi:10.1097/01.ju.0000085787.21140.db

29. Magera JS, Elliott DS. Tandem transcorporal artificial urinary sphincter cuff salvage technique: surgical description and results. J Urol. 2007;177(3):1015–9. doi:10.1016/j.juro.2006.10.052

30. Guralnick ML, Miller E, Toh KL, Webster GD. Transcorporal artificial urinary sphincter cuff placement in cases requiring revision for erosion and urethral atrophy. J Urol. 2002;167(5):2075–8. doi:10.1016/s0022-5347(05)65088-4. PMID 11956443

31. Moser DC, Kaufman MR, Milam DF, et al. Impact of radiation and transcorporeal artificial sphincter placement in patients with prior urethral cuff erosion: results from a retrospective multicenter analysis. J Urol. 2018;200(6):1338–1343. doi:10.1016/j.juro.2018.06.069

32. Averbeck MA, Woodhouse C, Comiter C, et al. Surgical treatment of post-prostatectomy stress urinary incontinence in adult men: report from the 6th International Consultation on Incontinence. Neurourol Urodyn. 2019;38(1):398–406. doi:10.1002/nau.23845

33. Trost L, Elliott D. Small intestinal submucosa urethral wrap at the time of artificial urinary sphincter placement as a salvage treatment option for patients with persistent/recurrent incontinence following multiple prior sphincter failures and erosions. Urology. 2012;79(4):933–8. doi:10.1016/j.urology.2011.09.003

34. Rozanski AT, Tausch TJ, Ramirez D, et al. Immediate urethral repair during explantation prevents stricture formation after artificial urinary sphincter cuff erosion. J Urol. 2014;192(2):442–6. doi:10.1016/j.juro.2014.02.007

35. Linder BJ, de Cogain M, Elliott DS. Long-term device outcomes of artificial urinary sphincter reimplantation following prior explantation for erosion or infection. J Urol. 2014;191(3):734–8. doi:10.1016/j.juro.2013.08.089

36. Lai HH, Boone TB. Complex artificial urinary sphincter revision and reimplantation cases — how do they fare compared to virgin cases? J Urol. 2012;187(3):951–5. doi:10.1016/j.juro.2011.10.153

37. Raj GV, Peterson AC, Toh KL, Webster GD. Outcomes following revisions and secondary implantation of the artificial urinary sphincter. J Urol. 2005;173(4):1242–5. doi:10.1097/01.ju.0000152315.91444.d0

38. Van Dyke M, Ortiz N, Baumgarten A, et al. Permanent urethral ligation after AUS cuff erosion: is it ready for prime time? Neurourol Urodyn. 2021;40(1):211–218. doi:10.1002/nau.24535

39. Maurer V, Dahlem R, Rosenbaum CM, et al. Distal double cuff vs transcorporal cuff as salvage options — a prospective analysis of different artificial urinary sphincter (AMS 800) implantation sites. Urology. 2019;133:234–239. doi:10.1016/j.urology.2019.07.018

40. Krughoff K, Nosé BD, Peterson AC. Artificial urinary sphincter cuff downsizing improves continence and patient satisfaction in cases of sub-cuff atrophy. J Urol. 2023;209(4):742–751. doi:10.1097/JU.0000000000003138

41. Saffarian A, Walsh K, Walsh IK, Stone AR. Urethral atrophy after artificial urinary sphincter placement: is cuff downsizing effective? J Urol. 2003;169(2):567–9. doi:10.1097/00005392-200302000-00026

42. Couillard DR, Vapnek JM, Stone AR. Proximal artificial sphincter cuff repositioning for urethral atrophy incontinence. Urology. 1995;45(4):653–6. doi:10.1016/s0090-4295(99)80058-2

43. O'Connor RC, Lyon MB, Guralnick ML, Bales GT. Long-term follow-up of single versus double cuff artificial urinary sphincter insertion for the treatment of severe postprostatectomy stress urinary incontinence. Urology. 2008;71(1):90–3. doi:10.1016/j.urology.2007.08.017

44. Manka MG, Wright EJ. Does use of a second cuff improve artificial urinary sphincter effectiveness? Evaluation using a comparative cadaver model. J Urol. 2015;194(6):1688–91. doi:10.1016/j.juro.2015.06.102

45. Yafi FA, DeLay KJ, Stewart C, et al. Device survival after primary implantation of an artificial urinary sphincter for male stress urinary incontinence. J Urol. 2017;197(3 Pt 1):759–765. doi:10.1016/j.juro.2016.08.107

46. Ahyai SA, Ludwig TA, Dahlem R, et al. Outcomes of single- vs double-cuff artificial urinary sphincter insertion in low- and high-risk profile male patients with severe stress urinary incontinence. BJU Int. 2016;118(4):625–32. doi:10.1111/bju.13449

47. Domínguez Gutiérrez A, Hevia Palacios M, López Curtis DA, et al. Transcorporal cuff-placement in artificial urinary sphincter surgery: a systematic review. Urology. 2026;208:173-178. doi:10.1016/j.urology.2025.11.222

48. Wiedemann L, Cornu JN, Haab E, et al. Transcorporal artificial urinary sphincter implantation as a salvage surgical procedure for challenging cases of male stress urinary incontinence: surgical technique and functional outcomes in a contemporary series. BJU Int. 2013;112(8):1163–8. doi:10.1111/bju.12386

49. Ortiz NM, Wolfe AR, Baumgarten AS, et al. Artificial urinary sphincter cuff erosion heat map shows similar anatomical characteristics for transcorporal and standard approach. J Urol. 2020;204(5):1027–1032. doi:10.1097/JU.0000000000001148

50. Mock S, Dmochowski RR, Brown ET, et al. The impact of urethral risk factors on transcorporeal artificial urinary sphincter erosion rates and device survival. J Urol. 2015;194(6):1692–6. doi:10.1016/j.juro.2015.06.088

51. Bugeja S, Ivaz SL, Frost A, Andrich DE, Mundy AR. Urethral atrophy after implantation of an artificial urinary sphincter: fact or fiction? BJU Int. 2016;117(4):669–76. doi:10.1111/bju.13324

52. Terlecki RP, Wilson SK. A new paradigm for surgical revision of the artificial urinary sphincter for recurrent stress urinary incontinence: Wilson's Workshop 11. Int J Impot Res. 2022;34(1):37–43. doi:10.1038/s41443-020-0307-8

53. Heah NH, Tan RBW. Management of urethral atrophy after implantation of artificial urinary sphincter: what are the weaknesses? Asian J Androl. 2020;22(1):60–63. doi:10.4103/aja.aja_110_19

54. Khouri RK, Baumgarten AS, Ortiz NM, et al. Pressure regulating balloon herniation: a correctable cause of artificial urinary sphincter malfunction. Urology. 2020;139:188–192. doi:10.1016/j.urology.2020.01.036

55. Loh-Doyle JC, Nazemi A, Ashrafi A, et al. Predictors of device-related complications after exchange of the pressure-regulating balloon in men with an artificial urinary sphincter. Urology. 2020;135:154–158. doi:10.1016/j.urology.2019.09.026

56. Kobashi KC, Vasavada S, Bloschichak A, et al. Updates to surgical treatment of female stress urinary incontinence (SUI): AUA/SUFU guideline (2023). J Urol. 2023;209(6):1091–1098. doi:10.1097/JU.0000000000003435

57. Biardeau X, Aharony S, AUS Consensus Group, Campeau L, Corcos J. Artificial urinary sphincter: report of the 2015 consensus conference. Neurourol Urodyn. 2016;35 Suppl 2:S8–24. doi:10.1002/nau.22989

58. Chartier-Kastler E, Van Kerrebroeck P, Olianas R, et al. Artificial urinary sphincter (AMS 800) implantation for women with intrinsic sphincter deficiency: a technique for insiders? BJU Int. 2011;107(10):1618–26. doi:10.1111/j.1464-410X.2010.09610.x

59. Peyronnet B, O'Connor E, Khavari R, et al. AMS-800 artificial urinary sphincter in female patients with stress urinary incontinence: a systematic review. Neurourol Urodyn. 2019;38 Suppl 4:S28–S41. doi:10.1002/nau.23833

60. Phé V, Léon P, Granger B, et al. Stress urinary incontinence in female neurological patients: long-term functional outcomes after artificial urinary sphincter (AMS 800) implantation. Neurourol Urodyn. 2017;36(3):764–769. doi:10.1002/nau.23019

61. Bracchitta D, Costa P, Borojeni S, et al. Laparoscopic artificial urinary sphincter implantation in women with stress urinary incontinence: update on 13 years' experience in a single centre. BJU Int. 2019;123(5A):E14–E19. doi:10.1111/bju.14653

62. Ferreira C, Brychaert PE, Menard J, Mandron E. Laparoscopic implantation of artificial urinary sphincter in women with intrinsic sphincter deficiency: mid-term outcomes. Int J Urol. 2017;24(4):308–313. doi:10.1111/iju.13296

63. 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. Eur Urol. 2019;75(1):169–175. doi:10.1016/j.eururo.2018.07.036

64. Biardeau X, Rizk J, Marcelli F, Flamand V. Robot-assisted laparoscopic approach for artificial urinary sphincter implantation in 11 women with urinary stress incontinence: surgical technique and initial experience. Eur Urol. 2015;67(5):937–42. doi:10.1016/j.eururo.2014.12.041

65. Gondran-Tellier B, Boissier R, Baboudjian M, et al. Robot-assisted implantation of an artificial urinary sphincter, the AMS-800, via a posterior approach to the bladder neck in women with intrinsic sphincter deficiency. BJU Int. 2019;124(6):1077–1080. doi:10.1111/bju.14884

66. Broudeur L, Loubersac T, Le Normand L, et al. New technique of robot-assisted laparoscopic artificial urinary sphincter implantation in female by a posterior approach with intraoperative cystoscopic monitoring. World J Urol. 2021;39(11):4221–4226. doi:10.1007/s00345-021-03739-w

67. Dubois A, Capon G, Belas O, et al. Open vs. robot-assisted artificial urinary sphincter implantation in women with stress urinary incontinence: a multicenter comparative study. J Clin Med. 2025;14(1):284. doi:10.3390/jcm14010284

68. 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. Neurourol Urodyn. 2023;42(1):80–89. doi:10.1002/nau.25047

69. Cefalu CA, Deng X, Zhao LC, et al. Safety of the "drain and retain" option for defunctionalized urologic prosthetic balloons and reservoirs during artificial urinary sphincter and inflatable penile prosthesis revision surgery: 5-year experience. Urology. 2013;82(6):1436–9. doi:10.1016/j.urology.2013.07.038

70. Pereira TA, Good J, Rust JO, et al. Early clinical outcomes of the "drain and retain" maneuver in inflatable penile prosthesis revision surgery: a multi-institutional review. J Sex Med. 2026;23(3):qdag024. doi:10.1093/jsxmed/qdag024

71. Fishman IJ, Shabsigh R, Scott FB. Experience with the artificial urinary sphincter model AS800 in 148 patients. J Urol. 1989;141(2):307–10. doi:10.1016/s0022-5347(17)40748-8

72. 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. Neurourol Urodyn. 2026;45(1):162–68. doi:10.1002/nau.70162

73. Park CR, Kim JH, Oh KT. In situ urethroplasty at the time of artificial urinary sphincter explantation for urethral erosion: an 18-year single-center experience. World J Urol. 2026;44(1):525. Published July 27, 2026. doi:10.1007/s00345-026-06629-1.

74. Boston Scientific. AMS 800 Artificial Urinary Sphincter: Male Instructions for Use. 51266569-01A. Sections: InhibiZone; warnings/precautions; prospective PIF post-market registry; deactivation/reactivation. Manufacturer IFU.

75. Barakat B, Franke K, Hijazi S, et al. A systematic review and meta-analysis of clinical and functional outcomes of artificial urinary sphincter implantation in women with stress urinary incontinence. Arab J Urol. 2020;18(2):78-87. doi:10.1080/2090598x.2020.1716293. PMID 33029411

76. Ramez M, Abdelshafi A, Adel Mohammed Y, et al. Perineal versus penoscrotal approach for implantation of artificial urinary sphincter: a systematic review and meta-analysis. Int Urol Nephrol. 2025;57(12):3925-3932. doi:10.1007/s11255-025-04603-1

77. Breyer BN, Kim SK, Kirkby E, et al. Updates to Incontinence After Prostate Treatment: AUA/GURS/SUFU Guideline (2024). J Urol. 2024;212(4):531-538. doi:10.1097/JU.0000000000004088

78. National Institute for Health and Care Excellence. Urinary incontinence and pelvic organ prolapse in women: management. NG123. Published April 2019; last updated June 2019. Recommendations 1.5.12-1.5.13. Recommendations

79. Boston Scientific. AMS 800 Urinary Control System: Operating Room Manual (male, female and pediatric patients). 92116967-01A. Sections: Device Description; Bladder-Neck Cuff Placement; Bulbous Urethra Cuff Placement. Manufacturer manual.

80. Boston Scientific (American Medical Systems). AMS 800 Urinary Control System for Male Patients: Operating Room Manual. 92116964-01A, English. Sections: System Operation; Device Description; surgical procedures; Deactivate and Activate Cuff; Double Cuff; Post Operative Care. Earlier edition than the current IFU (ref 74); use the labeling supplied with the implant.

81. Boston Scientific (American Medical Systems). AMS 800 Urinary Control System for Male Patients: Instructions for Use (US). 1004681-A. MRI section (earlier edition); prospective study and PIF registry.

82. Boston Scientific. AMS 800 Artificial Urinary Sphincter for Male Patients: Directions for Use. 50654580-01A, English section. MRI section (3 T conditions).

83. Sundaram V, Cordon BH, Hofer MD, Morey AF. Is Risk of Artificial Urethral Sphincter Cuff Erosion Higher in Patients with Penile Prosthesis? J Sex Med. 2016;13(9):1432-1437. doi:10.1016/j.jsxm.2016.06.013

84. Boysen WR, Cohen AJ, Kuchta K, Park S, Milose J. Combined Placement of Artificial Urinary Sphincter and Inflatable Penile Prosthesis Does Not Increase Risk of Perioperative Complications or Impact Long-term Device Survival. Urology. 2019;124:264-270. doi:10.1016/j.urology.2018.10.033

85. Ashley RA, Husmann DA. Artificial urinary sphincters placed after posterior urethral distraction injuries in children are at risk for erosion. J Urol. 2007;178(4 Pt 2):1813-1815. doi:10.1016/j.juro.2007.05.095

86. Montague DK. Artificial Urinary Sphincter Implantation in the Adult Male. In: Montague DK, Gill IS, Angermeier KW, Ross JH, eds. Textbook of Reconstructive Urologic Surgery. Informa Healthcare; 2008:392-398.

87. Smith PJ, Hudak SJ, Scott JF, Zhao LC, Morey AF. Transcorporal artificial urinary sphincter cuff placement is associated with a higher risk of postoperative urinary retention. Can J Urol. 2013;20(3):6773-6777. PMID 23783046

88. Chartier Kastler E, Genevois S, Gamé X, et al. Treatment of neurogenic male urinary incontinence related to intrinsic sphincter insufficiency with an artificial urinary sphincter: a French retrospective multicentre study. BJU Int. 2011;107(3):426-432. doi:10.1111/j.1464-410X.2010.09501.x

89. Yates DR, Phé V, Rouprêt M, Vaessen C, Parra J, Mozer P, Chartier-Kastler E. Robot-assisted laparoscopic artificial urinary sphincter insertion in men with neurogenic stress urinary incontinence. BJU Int. 2013;111(7):1175-1179. doi:10.1111/bju.12072

90. Ruiz E, Puigdevall J, Moldes J, et al. 14 years of experience with the artificial urinary sphincter in children and adolescents without spina bifida. J Urol. 2006;176(4 Pt 2):1821-1825. doi:10.1016/j.juro.2006.05.024

91. Bazinet A, Chartier-Kastler E, Gazdovich S. Artificial Urinary Sphincter for Female Stress Urinary Incontinence. In: Martins FE, Holm HV, Sandhu JS, McCammon KA, eds. Female Genitourinary and Pelvic Floor Reconstruction. Springer; 2023:407-436. doi:10.1007/978-3-031-19598-3_24

92. Fishman IJ, Scott FB. Pregnancy in patients with the artificial urinary sphincter. J Urol. 1993;150(2 Pt 1):340-341. doi:10.1016/s0022-5347(17)35479-4

93. Elliott DS, Barrett DM, Gohma M, Boone TB. "Does nocturnal deactivation of the artificial urinary sphincter lessen the risk of urethral atrophy?" Urology. 2001;57(6):1051-1054. doi:10.1016/s0090-4295(01)00963-3

94. Brito CG, Mulcahy JJ, Mitchell ME, Adams MC. "Use of a double cuff AMS800 urinary sphincter for severe stress incontinence." J Urol. 1993;149(2):283-285. doi:10.1016/s0022-5347(17)36057-3

95. Simhan J, Morey AF, Singla N, Tausch TJ, Scott JF, Lemack GE, et al. "3.5 cm artificial urinary sphincter cuff erosion occurs predominantly in irradiated patients." J Urol. 2015;193(2):593-597. doi:10.1016/j.juro.2014.07.115

96. Benson CR, Ayoub HI, Westney OL. "Single perineal incision placement of artificial urinary sphincter with cadaveric correlation of sub-dartos pump placement." Int Braz J Urol. 2018;44(2):355-361. doi:10.1590/S1677-5538.IBJU.2017.0097

97. Wilson SK, Delk JR 2nd, Henry GD, Siegel AL. "New surgical technique for sphincter urinary control system using upper transverse scrotal incision." J Urol. 2003;169(1):261-264. doi:10.1016/S0022-5347(05)64082-7

98. 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;86(3):602–607. doi:10.1016/j.urology.2015.05.029

99. 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. doi:10.21037/tau.2019.08.02

100. Loloi J, et al. "Case series - Small bowel obstruction secondary to retained male urinary and sexual prostheses reservoirs." Can Urol Assoc J. 2022;16(7):E403-E405. doi:10.5489/cuaj.7773

101. 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

102. Litwiller SE, Kim KB, Fone PD, et al. "Post-prostatectomy incontinence and the artificial urinary sphincter: a long-term study of patient satisfaction and criteria for success." J Urol. 1996;156(6):1975-1980. doi:10.1016/s0022-5347(01)65408-9

103. Constable L, Drake MJ, Cooper D, et al. "The 24-mo outcomes from the noninferiority randomised controlled trial of surgery for men with urodynamic stress incontinence after prostate surgery (MASTER)." Eur Urol Focus. 2026;12(4):636-643. doi:10.1016/j.euf.2026.07.012

104. Tokarski E, Taillé Y, Chartier-Kastler E, et al. "Survival without reintervention of second artificial urinary sphincter implants in men: a national healthcare data system-based study in France." Int Braz J Urol. 2026;52(1):e20250374. doi:10.1590/S1677-5538.IBJU.2025.0374

105. Davis MF, Nikolavsky D, Cavalcanti AG, et al. "Multicenter analysis of long-term outcomes of artificial urinary sphincter surgery after urethroplasty." J Urol. 2026;215(2):203-212. doi:10.1097/JU.0000000000004794

106. European Association of Urology. EAU Guidelines on Non-neurogenic Female LUTS: Disease Management. 2026. Guideline.

107. Boston Scientific. "Male Continence Products." Manufacturer page. Accessed 2026-10-08.

108. European Association of Urology. EAU Guidelines on the Management of Non-neurogenic Male LUTS: Disease Management. 2026. Guideline.

109. Radomski SB, Ruzhynsky V, Wallis CJD, Herschorn S. "Complications and Interventions in Patients with an Artificial Urinary Sphincter: Long-Term Results." J Urol. 2018;200(5):1093–1098. doi:10.1016/j.juro.2018.05.143.

110. Hüsch T, Kretschmer A, Thomsen F, et al. "Risk Factors for Failure of Male Slings and Artificial Urinary Sphincters: Results from a Large Middle European Cohort Study." Urol Int. 2017;99(1):14–21. doi:10.1159/000449232.

111. Ziegelmann MJ, Hebert KJ, Linder BJ, Rangel LJ, Elliott DS. "The 'Minimal-Touch' Technique for Artificial Urinary Sphincter Placement: Description and Outcomes." Urol Res Pract. 2023;49(1):40-47. doi:10.5152/tud.2023.22136

112. Ravier E, Fassi-Fehri H, Crouzet S, Gelet A, Abid N, Martin X. "Complications after artificial urinary sphincter implantation in patients with or without prior radiotherapy." BJU Int. 2015;115(2):300-307. doi:10.1111/bju.12777

113. Mamane J, Sanchez S, Lellouch AG, et al. "Impact of radiation therapy on artificial urinary sphincter implantation in male patients: A multicenter study." Neurourol Urodyn. 2022;41(1):332-339. doi:10.1002/nau.24825

114. Sandhu JS, Breyer B, Comiter C, et al. "Incontinence after prostate treatment: AUA/SUFU guideline." J Urol. 2019;202(2):369-378. doi:10.1097/JU.0000000000000314

115. Le Long E, Rebibo JD, Nouhaud FX, Grise P. "Transcorporal artificial urinary sphincter in radiated and non - radiated compromised urethra. Assessment with a minimum 2 year follow-up." Int Braz J Urol. 2016;42(3):494–500. doi:10.1590/S1677-5538.IBJU.2015.0329