Stress Urinary IncontinenceAUSCONCT04088331

Artificial Urinary Sphincter Clinical Outcomes

An observational study of Stress Urinary Incontinence, run by Boston Scientific Corporation at 18 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests. Read more about this study

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Stress Urinary Incontinence
What is being tested?: AMS 800 Artificial Urinary Sphincter
Type of treatment: Medical device
How many people: 145 participants
Where: 18 sitesin 2 countries
Study dates: 14 Oct 2019to 13 May 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Study population: This study will enroll adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.

Who may be able to join

Male
≥ 18 years of age
Has undergone either a radical prostatectomy, transurethral resection of the prostate or other invasive prostate surgery
Demonstrates primary stress urinary incontinence
Positive screening 24-hour pad weight test (≥100 grams)
Experiences at least 3 incontinence episodes per day during baseline diary or presents with continuous incontinence

Show all 11Show fewer

Negative urine culture
Willing and able to undergo surgical implantation of the AUS device
Willing and able to comply with the follow-up requirements
Willing and able to forego any other surgical urinary incontinence treatments while participating in the study
Willing and able to sign the informed consent

Who cannot join

Previously had or currently has a device implanted (AUS/Sling, or otherwise) for treatment of SUI or urge incontinence
Primary urgency incontinence
Postvoid residual volume greater that 150 ml or a history of difficulty emptying the bladder
Recurrent vesicourethral anastomotic stricture or urethral stricture disease within the past 6 months
Known urogenital malignancy other than previously treated prostate cancer
Recurrent prostate cancer that is expected to require intervention during the study follow-up period

Show all 22Show fewer

History of recurrent bladder stones within the past 12 months prior to signing the informed consent
Neurogenic bladder
Need for intermittent catheterization
Known history of bleeding diathesis or coagulopathy
Immunosuppressed or on medical therapy which would impact the immune system
Uncontrolled diabetes, defined as (HbA1c>10)
Has a genitourinary mechanical prosthesis that was implanted within 3 months from the date of consent
Had a post-implantation infection associated with the device after genitourinary mechanical prosthesis was implanted
Undergone bulking procedure within 6 months of the baseline assessment
Poor candidate for surgical procedures and/or anesthesia due to physical or mental conditions
Urinary incontinence due to or complicated by an irreversibly obstructed lower urinary tract
Irresolvable detrusor hyperreflexia or bladder instability
Currently enrolled or plans to enroll in another device or drug clinical trial
Currently using an indwelling catheter or condom catheter for treatment of incontinence and is not willing to discontinue use at least 4 weeks prior to baseline assessment
Known allergy or sensitivity to rifampin or to minocycline HCl or other tetracyclines (only applicable when implanting with InhibiZone version of this device)
Systemic lupus erythematosus because minocycline HCl has been reported to aggravate this condition (only applicable when implanting with InhibiZone version of this device)

Trial locations and contacts

18 sites in 2 countries.

Country

City, postcode or hospital

18 sites in 2 countries

United States16 sites

University of Colorado Hospital
Aurora, Colorado, 80045
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Willis-Knighton Bossier Medical Center
Bossier City, Louisiana, 71111
Lahey Clinic Hospital
Burlington, Massachusetts, 01805
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
The Methodist Hospital Research Institute
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Kansas Hospital
Kansas City, Kansas, 66160-7234
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Utah
Salt Lake City, Utah, 84132
Urology San Antonio Research, PA.
San Antonio, Texas, 78229
University of California, San Francisco
San Francisco, California, 94110
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27103

Other trials in United States

Australia2 sites

Concord Repatriation General Hospital
Concord, New South Wales, 2139
Australian Urology Associates
Melbourne, Victoria, 3144

Other trials in Australia

About this study

To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.

Read the detailed description

Study is designed to evaluate the performance of the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.

Conditions: Stress Urinary Incontinence
Being tested: AMS 800 Artificial Urinary Sphincter
Medical subject headings: Urinary Incontinence, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AMS 800 Artificial Urinary SphincterDevice
The AMS 800 Artificial Urinary Sphincter (AUS) is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence due to reduced urethral/bladder outlet resistance (intrinsic sphincter deficiency). It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra under the control of the patient.

Study groups in NCT04088331
Study group	Role	What they receive
AMS 800 Artificial Urinary Sphincter Recipients		Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence. Receives: Device: AMS 800 Artificial Urinary Sphincter

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Reduction in 24 Hour Pad Weight Test at 12 Months
Number of subjects achieving 50% reduction or greater in baseline urinary incontinence as measured by 24-hour pad weight test at 12 months post device activation
Measured: 12 months

Secondary outcomes (9)

Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related
Percentage of Participants that Required Revision (Revision Rates), had Serious Adverse Events, and had Serious Adverse Events that are Device and/or Procedure Related at 3 months, 6 months, and 12 months. Adverse event and revision rates are summarized by the Kaplan-Meier estimate with revision/event timing relative to the index procedure.
Measured: 3 months, 6 months, and 12 months
Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at Device Activation
Number of subjects achieving ≥ 50% reduction in urinary incontinence as measured by 24-hour pad weight test at device activation compared to baseline
Measured: Device Activation
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at Device Activation
≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at device activation compared to baseline
Measured: Device Activation
Change in Number of Pads Per Day at 3 Months
Change in number of pads per day at 3 months compared to baseline. Change was calculated by subtracting the number of pads per day at baseline from the number of pads per day at 3 months.
Measured: 3 months
Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at 6 Months
Number of subjects achieving ≥ 50% reduction in urinary incontinence as measured by 24-hour pad weight test at 6 months post device activation compared to baseline
Measured: 6 months
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 6 Months
≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at 6 months post device activation compared to baseline
Measured: 6 months
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 12 Months
≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at 12 months post device activation compared to baseline
Measured: 12 months
Change in Number of Pads Per Day at 6 Months
Change in number of pads per day at 6 months post-device activation compared to baseline. Change was calculated by subtracting the number of pads per day at baseline from the number of pads per day at 6 months.
Measured: 6 months
Change in Number of Pads Per Day at 12 Months
Change in number of pads per day at 12 months post-device activation compared to baseline. Change was calculated by subtracting the number of pads per day at baseline from the number of pads per day at 12 months.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Oct 201913 May 2024

First posted12 Sep 2019
Study start14 Oct 2019
Primary completion13 May 2024
Study completion13 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04088331
Sponsor's protocol ID: U0669
Acronym: AUSCO
Status last verified: Dec 2025
First submitted: 10 Sep 2019
Last updated: 14 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chandrasekhar V, Kaufman MR, Peterson AC, Chaussee EL, Wood HM; AUSCO Collaboration Group. One-Year Functional Satisfaction and Quality of Life Outcomes of Patients With a History of Radiotherapy With Artificial Urinary Sphincters. Neurourol Urodyn. 2026 Sep;45(7):1357-1365. doi: 10.1002/nau.70321. Epub 2026 Jun 2.
PubMed 42226712
Kaufman MR, Wood HM, Terlecki R, Moon D, Myers J, Vanni AJ, Jones L, Broghammer JA, Henry G, Breyer BN, Erickson B, Burnett AL, Johnsen NV, Loong Chan LW, Flynn BJ, Khavari R, Smith TG 3rd, Elliott S, Chaussee EL, Rainbow K, Peterson AC. The Artificial Urinary Sphincter Clinical Outcomes Trial: Primary Results. J Urol. 2026 Feb;215(2):194-202. doi: 10.1097/JU.0000000000004796. Epub 2025 Oct 3.
PubMed 41042705

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stress Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Artificial Urinary Sphincter Clinical Outcomes
ClinicalTrials.gov ID: NCT04088331
Acronym / sponsor ID: AUSCO / U0669
Conditions: Stress Urinary Incontinence
Study type: Observational
Recruitment status: Completed
Enrolment: 145 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 14 Oct 2019 (actual)
Primary completion: 13 May 2024 (actual)
Study completion: 13 May 2024 (actual)
First posted: 12 Sep 2019 (actual)
Results: Posted 3 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.

Detailed description

Study is designed to evaluate the performance of the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
AMS 800 Artificial Urinary Sphincter Recipients	–	Device: AMS 800 Artificial Urinary SphincterAdult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: This study will enroll adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.

Key inclusion criteria (11 listed)

Male
≥ 18 years of age
Has undergone either a radical prostatectomy, transurethral resection of the prostate or other invasive prostate surgery
Demonstrates primary stress urinary incontinence
Positive screening 24-hour pad weight test (≥100 grams)

Key exclusion criteria (22 listed)

Previously had or currently has a device implanted (AUS/Sling, or otherwise) for treatment of SUI or urge incontinence
Primary urgency incontinence
Postvoid residual volume greater that 150 ml or a history of difficulty emptying the bladder
Recurrent vesicourethral anastomotic stricture or urethral stricture disease within the past 6 months
Known urogenital malignancy other than previously treated prostate cancer

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AMS 800 Artificial Urinary SphincterThe AMS 800 Artificial Urinary Sphincter (AUS) is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence due to reduced urethral/bladder outlet resistance (intrinsic sphincter deficiency). It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra under the control of the patient.	Device	AMS 800 Artificial Urinary Sphincter Recipients

Primary outcome

Number of Subjects With Reduction in 24 Hour Pad Weight Test at 12 Months
Time frame: 12 months
Number of subjects achieving 50% reduction or greater in baseline urinary incontinence as measured by 24-hour pad weight test at 12 months post device activation

9 secondary outcomes

Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related
Time frame: 3 months, 6 months, and 12 months
Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at Device Activation
Time frame: Device Activation
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at Device Activation
Time frame: Device Activation
Change in Number of Pads Per Day at 3 Months
Time frame: 3 months
Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at 6 Months
Time frame: 6 months
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 6 Months
Time frame: 6 months
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 12 Months
Time frame: 12 months
Change in Number of Pads Per Day at 6 Months
Time frame: 6 months
Change in Number of Pads Per Day at 12 Months
Time frame: 12 months

Results and safety

Results posted to the registry on 3 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AMS 800 Artificial Urinary Sphincter Recipients	115	101

Primary outcome: Number of Subjects With Reduction in 24 Hour Pad Weight Test at 12 Months

Time frame: 12 months. Count of participants. Unit: Participants

Measure	AMS 800 Artificial Urinary Sphincter Recipients n = 97
Value	91

AMS 800 Artificial Urinary Sphincter Recipients: p < 0.001, Exact binomial test

Population analysed: The analysis was performed on subjects in the Intent to Treat (ITT) population who had available 24-hr pad weight data available at their 12 month follow-up visit. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study, and have a surgery initiated (defined as the first incision).

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AMS 800 Artificial Urinary Sphincter Recipients	17 of 115 (14.8%)	27 of 115 (23.5%)	3 of 115

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42226712Chandrasekhar V, Kaufman MR, Peterson AC, Chaussee EL, Wood HM; AUSCO Collaboration Group. One-Year Functional Satisfaction and Quality of Life Outcomes of Patients With a History of Radiotherapy With Artificial Urinary Sphincters. Neurourol Urodyn. 2026 Sep;45(7):1357-1365. doi: 10.1002/nau.70321. Epub 2026 Jun 2.
Derived from this study: PubMed 41042705Kaufman MR, Wood HM, Terlecki R, Moon D, Myers J, Vanni AJ, Jones L, Broghammer JA, Henry G, Breyer BN, Erickson B, Burnett AL, Johnsen NV, Loong Chan LW, Flynn BJ, Khavari R, Smith TG 3rd, Elliott S, Chaussee EL, Rainbow K, Peterson AC. The Artificial Urinary Sphincter Clinical Outcomes Trial: Primary Results. J Urol. 2026 Feb;215(2):194-202. doi: 10.1097/JU.0000000000004796. Epub 2025 Oct 3.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Melissa Kaufman, MD principal investigator

Vanderbilt Urology

18 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Stress Urinary Incontinence, run by Boston Scientific Corporation at 18 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Reduction in 24 Hour Pad Weight Test at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04088331, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.