AUSCO: Artificial Urinary Sphincter Clinical Outcomes Trial

Bottom line Descriptive

In 115 men receiving the AMS 800 artificial urinary sphincter at 17 centers, 94% (91/97 with pad weights) had at least a 50% reduction in 24-hour pad weight at 12 months, exceeding the 65% performance goal; 60% used no pads and 7.8% had a revision.

Performance goal exceeded; single-arm, manufacturer-funded, high-volume surgeons, 12 months of follow-up.

AUSCO was a prospective, multicenter, single-arm study of the AMS 800 artificial urinary sphincter in 115 men with moderate-to-severe primary stress urinary incontinence at 17 sites in the United States and Australia, with success defined as at least a 50% reduction in 24-hour pad weight 12 months after activation. Of 97 men with a 12-month pad weight, 94% (91) met that definition, exceeding the 65% performance goal, and 60% (61/101) reported no pad use.^[1]

Design and population

Prospective multicenter single-arm study with a prespecified performance goal. Men with moderate-to-severe primary stress incontinence from intrinsic sphincteric deficiency (24-hour pad weight at least 100 g) who received a first AMS 800 sphincter at 17 sites in the United States and Australia.

Arms

AMS 800 artificial urinary sphincter

Report and follow-up

2025 · 12 months after device activation; final 12-month visit completed May 2024; 101 of 115 completed the 12-month visit

Endpoint	Results	Effect	Finding
At least 50% reduction in 24-hour pad weight at 12 months (available case; goal above 65%)	94% (91/97)	95%, Clopper-Pearson 87–98; P <0.001	Met

Harms: Any adverse event: 33% (38/115), 61 events; Device- or procedure-related adverse event: 28% (32/115), 43 events; Serious adverse event: 15% (17/115), 26 events

NCT04088331 · Report DOI

Design

Eligible men were adults with intrinsic sphincteric deficiency who met the indications for surgery and had a baseline 24-hour pad weight of at least 100 g. Men with prior pelvic radiation were excluded until protocol version C (November 2021). Enrollment began in October 2019, and the last 12-month visit was completed in May 2024. Participants served as their own controls, with visits at 3, 6 and 12 months after activation.^[1]

Treatment success was a reduction of at least 50% in 24-hour pad weight from baseline. The study was powered to test whether the success proportion exceeded 65%, assuming a true rate of 80%, which required 96 participants (one-sided type I error 0.025, power 90%). The analysis was available-case with a one-sided exact binomial test and a tipping-point analysis for missing data. Secondary endpoints were pad weight at other time points, a 75% reduction threshold, pads per day, safety and revision rates, and patient-reported outcomes (I-QOL, IIQ-7, EQ-5D-5L, voiding diary and device satisfaction). Subgroup analyses by age, race, BMI, diabetes, coronary disease, prior radiotherapy, prior robotic prostatectomy, stricture history, baseline mobility and self-care, and hospital stay were exploratory.^[1]

Results

At 12 months, 112 of 115 men had completed device activation and 101 completed the 12-month visit, of whom 97 had a 24-hour pad weight. The primary endpoint was met: 91 of 97 (94%; 95% CI 87% to 98%) had at least a 50% reduction (one-sided P < 0.001), and 83 of 97 (86%) had at least a 75% reduction. Eighteen implanted men had no 12-month pad weight (14 left the study early and 4 missed the assessment); counting all of them as failures, the success rate was 79% (91/115; 95% CI 71% to 86%), still above 65%.^[1]

Mean 24-hour pad weight fell from 653.2 g to 73.7 g (change −579.4 g; 95% CI −682.0 to −476.8), and mean pads per day from 4.8 to 0.9 (change −3.9; 95% CI −4.4 to −3.4). Sixty-one of 101 men (60%) used no pads, and 88 of 96 (92%) were satisfied with the device. Diary-recorded incontinence events of any type fell from 5.2 to 2.1 per day. The I-QOL total score rose from 44.7 to 80.2 and the IIQ-7 score fell from 49.7 to 17.8.^[1]

In exploratory subgroups, at least a 50% pad-weight reduction was reached by 84% (16/19) of men with a BMI of 35 or more and 98% (47/48) of men with a BMI below 30. Success was 94% (72/77) in men under 75 and 95% (19/20) in men 75 or older.^[1]

Prior radiotherapy

In a secondary analysis of the 25 irradiated men (23 had radiotherapy as adjuvant therapy), 100% (19/19) reached a 50% pad-weight reduction at 12 months versus 92.3% (72/78) of the other men (P = 0.59). No pads were used by 42.9% (9/21) versus 65.0% (52/80) at 12 months (P = 0.08), and by 78.9% (15/19) versus 51.3% (41/80) at 6 months (P = 0.04). The 12-month change in I-QOL total score was 33.8 versus 35.9 points (P = 0.65). The analysis was not designed to show equivalence between subgroups.^[2]

Quality of life and sexual health

Among 100 men with 12-month questionnaires, the proportion reporting at least a little depression on I-QOL item 5 fell from 85% to 39%, the proportion greatly affected emotionally by incontinence on IIQ-7 item 6 from 16% to 3%, and the proportion at least slightly anxious or depressed on EQ-5D-5L from 50% to 30% (all P < 0.0001).^[3] Postvoid dribbling persisted in 68% at 12 months, and sitting versus standing to void and urinal versus stall use changed little after implantation.^[4] Pad-weight reduction and ease of use predicted satisfaction; limited self-care or mobility predicted more difficulty using the device.^[4] Among men without erectile dysfunction by history review, the proportion extremely worried about sex because of urinary problems fell from 43.3% (39/90) to 12.2% (11/90); in the 8 men with erectile dysfunction and complete follow-up it fell from 50% (4/8) to 25% (2/8).^[5]

Surgery and treatment delivery

The cuff was placed around the bulbar urethra in every case. Cuff sizes were mostly 4.0, 4.5 or 5.0 cm (30%, 47% and 15%), with no 3.5 cm cuffs. All but 2 devices were antibiotic impregnated, all pressure-regulating balloons were 61 to 70 cmH2O, and 66% of balloons were placed submuscularly. Median operative time was 1.3 hours (Q1 to Q3, 1.0 to 1.6), 77% of men were discharged the same day, and 9 stayed 2 or more days.^[1]

Incontinence followed radical prostatectomy in 110 of 115 men (77 robotic-assisted); 6 had endoscopic BPH surgery, and 12 (10%) had a history of urethral stricture or bladder neck contracture. Median age was 70 years, 52% had a BMI of 30 or more, and 30% had diabetes. Incontinence had lasted a mean of 4 years, and 96% of pad users needed 3 or more pads per day.^[1]

Adverse events

Thirty-eight men (33%) had an adverse event, 32 (28%) had an event related to the device or procedure, 17 (15%) had a serious event, and 10 (8.7%) had a serious device- or procedure-related event, as adjudicated by an independent medical reviewer. Nine men (7.8%) underwent revision: 3 for mechanical malfunction (2.6%), 2 for erosion (1.7%), 1 for lack of efficacy and 4 for other reasons (pump induration, reservoir herniation, balloon herniation, loose cuff); one revision had two reasons, mechanical malfunction and pump induration. No revision was attributed to infection. Device deficiencies were recorded in 15 men (13%): cuff 8, pump 5 and pressure-regulating balloon 4, with balloon migration in 2.^[1]

Three men had postoperative wound infections that resolved without erosion or explantation. Three deaths occurred during the study (sepsis, cerebrovascular accident, unknown cause); one other case of serious sepsis was judged unrelated to the device or procedure. In exploratory subgroup analyses, serious adverse events were more frequent with a BMI of 35 or more (29%, 7/24, versus 11%, 6/55, below 30), with any baseline mobility or self-care problem, and with a multiday index stay; no differences were observed by age or radiotherapy history.^[1] In the radiotherapy analysis, any adverse event occurred in 36.0% (9/25) of irradiated men versus 32.2% (29/90), serious events in 16.0% versus 14.4%, and revision in 8.0% (2/25) versus 7.8% (7/90).^[2]

Limitations

Success was measured against a performance goal of 65%, chosen below the 80% rate assumed for power, with no comparison group. Sites and surgeons were high-volume (20 or more implants per year). Boston Scientific supported the study, and two authors are affiliated with the company. Follow-up ended at 12 months after activation. Erosion and infection could not be separated in the case report forms, so some revisions for erosion may have followed infection. Urodynamics were not required, and only 2 men had a diagnosis of overactive bladder. Men with a urethral stricture in the previous 6 months were not eligible, and prior urethroplasty outside the setting of prostate treatment was not recorded. Men treated with radiation after implantation were not studied. Subgroup findings were exploratory, and the irradiated subgroup contained 25 men.^[1]

In conversation

• Parallel to MASTER (2021). MASTER randomized a male sling against the artificial urinary sphincter; AUSCO followed sphincter outcomes in a single arm.

AUSCO's rate depends on the success definition: 94% reached a 50% pad-weight reduction, 86% reached 75%, and 60% used no pads,^[1] so another series is comparable only when it uses the same definition. MASTER randomized a male sling against the artificial urinary sphincter and is the comparative trial for this decision.

Report history

AUSCO report history

Published	Report	Cutoff	Headline results	Citation
2025-10-01	Emotional health analysis · pro	—	Participants reporting at least 'a little' depressed, baseline versus 12 months: 85% (85/100) at baseline; 39% (39/100) at 12 months; P <0.0001 Participants 'greatly' affected by incontinence, baseline versus 12 months: 16% (16/100) at baseline; 3% (3/100) at 12 months; P <0.0001 Participants at least 'slightly' anxious or depressed, baseline versus 12 months: 50% (50/100) at baseline; 30% (30/100) at 12 months; P <0.0001	Peterson AC, Wood HM, Myers J, et al. The Artificial Urinary Sphincter Improves Emotional Health in Men With Stress Urinary Incontinence: Results From the Prospective, Multi-institutional AUSCO Study. *Urology.* 2026;207:227-232. DOI
2025-10-03	12-month primary results · primary	—	At least 50% reduction in 24-hour pad weight at 12 months (available case; goal above 65%): 94% (91/97); 95%, Clopper-Pearson 87–98; P <0.001 Met At least 75% reduction in 24-hour pad weight at 12 months: 86% (83/97); CI 77–92 Mean (SD) 24-hour pad weight, baseline to 12 months, in 97 participants with both measurements: 653.2 g (520.1) to 73.7 g (141.3); difference -579.4; 95% -682–-476.8 Mean (SD) pads per day, baseline to 12 months, in 101 participants: 4.8 (2.1) to 0.9 (1.5); difference -3.9; 95% -4.4–-3.4 Zero pad use at 12 months: 60% (61/101); — Participants satisfied with the device at 12 months: 92% (88/96); — Mean (SD) incontinence events of any type per day by diary, baseline to 12 months, in 95 participants: 5.2 (3.5) to 2.1 (2.5); difference -3.1; 95% -3.9–-2.3 Mean (SD) I-QOL total score, baseline to 12 months, in 100 participants (higher is better): 44.7 (21.7) to 80.2 (19.5); difference 35.5; 95% 30.3–40.7 Mean (SD) IIQ-7 score, baseline to 12 months, in 100 participants (lower is better): 49.7 (26.9) to 17.8 (21.5); difference -31.9; 95% -38–-25.8 At least 50% pad-weight reduction at 12 months, BMI of 35 or more versus below 30: 84% (16/19) versus 98% (47/48); — At least 50% pad-weight reduction at 12 months, prior radiotherapy versus none: 100% (19/19) versus 92% (72/78); —	Kaufman MR, Wood HM, Terlecki R, et al. The Artificial Urinary Sphincter Clinical Outcomes Trial: Primary Results. *J Urol.* 2026;215(2):194-202. DOI
2025-11-27	Toileting habits and satisfaction · secondary	—	Participants with persistent postvoid dribbling at 12 months: 68%; P 0.02 Change in sitting versus standing and urinal versus stall use after implantation: Minimal change; not associated with satisfaction; —	Wood HM, Peterson AC, Breyer BN, et al. How Artificial Urinary Sphincter Impacts Toileting Habits 1 Year After Implantation. *Eur Urol Focus.* 2026;12(2):248-255. DOI
2026-05-25	Sexual quality of life · pro	—	Participants 'extremely' worried about sex because of urinary problems, men without erectile dysfunction, baseline versus 12 months: 43.3% (39/90) at baseline; 12.2% (11/90) at 12 months; P <0.001 Participants 'extremely' worried about sex, men with erectile dysfunction, baseline versus 12 months: 50% (4/8) at baseline; 25% (2/8) at 12 months; P 0.031	Jones L, Peterson AC, Wood HM, et al. Changes in sexual quality of life in patients with stress urinary incontinence treated with an artificial urinary sphincter; analysis of the artificial urinary sphincter clinical outcomes trial (AUSCO). *J Sex Med.* 2026;23(6):qdag144. DOI
2026-06-02	Prior radiotherapy subgroup · secondary	—	At least 50% pad-weight reduction at 12 months, prior radiotherapy versus none: 100% (19/19) versus 92.3% (72/78); P 0.59 Zero pads per day at 12 months, prior radiotherapy versus none: 42.9% (9/21) versus 65.0% (52/80); P 0.08 Change in I-QOL total score from baseline to 12 months, prior radiotherapy versus none: 33.8 versus 35.9 points; P 0.65	Chandrasekhar V, Kaufman MR, Peterson AC, et al. One-Year Functional Satisfaction and Quality of Life Outcomes of Patients With a History of Radiotherapy With Artificial Urinary Sphincters. *Neurourol Urodyn.* 2026;45(7):1357-1365. DOI

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References

1. Kaufman MR, Wood HM, Terlecki R, et al. "The Artificial Urinary Sphincter Clinical Outcomes Trial: Primary Results." J Urol. 2026;215(2):194-202. doi:10.1097/JU.0000000000004796

2. Chandrasekhar V, Kaufman MR, Peterson AC, et al. "One-Year Functional Satisfaction and Quality of Life Outcomes of Patients With a History of Radiotherapy With Artificial Urinary Sphincters." Neurourol Urodyn. 2026;45(7):1357-1365. doi:10.1002/nau.70321

3. Peterson AC, Wood HM, Myers J, et al. "The Artificial Urinary Sphincter Improves Emotional Health in Men With Stress Urinary Incontinence: Results From the Prospective, Multi-institutional AUSCO Study." Urology. 2026;207:227-232. doi:10.1016/j.urology.2025.09.037

4. Wood HM, Peterson AC, Breyer BN, et al. "How Artificial Urinary Sphincter Impacts Toileting Habits 1 Year After Implantation." Eur Urol Focus. 2026;12(2):248-255. doi:10.1016/j.euf.2025.11.001

5. Jones L, Peterson AC, Wood HM, et al. "Changes in sexual quality of life in patients with stress urinary incontinence treated with an artificial urinary sphincter; analysis of the artificial urinary sphincter clinical outcomes trial (AUSCO)." J Sex Med. 2026;23(6):qdag144. doi:10.1093/jsxmed/qdag144