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New sphincter implant shows promise for Post-Prostate surgery leakage

NCT ID NCT04088331

Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested an artificial urinary sphincter implant in 145 men with stress urinary incontinence after prostate surgery. The device is designed to mimic natural bladder control by opening and closing the urethra. Researchers measured how many men had at least a 50% reduction in urine leakage after 12 months. The study also tracked complications and the need for device revisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AMS 800 Artificial Urinary Sphincter (implantable device)
What this could lead to
If successful, this device could offer a reliable, long-term way to control urinary leakage in men after prostate surgery, improving quality of life.
What could go wrong
The device requires surgery to implant and may need revision or cause complications like infection or device malfunction. Results may not apply to all men with incontinence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

145 people

The number who actually took part.

Started

Oct 2019

Finished

May 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male 2. ≥ 18 years of age 3. Has undergone either a radical prostatectomy, transurethral resection of the prostate or other invasive prostate surgery 4. Demonstrates primary stress urinary incontinence 5. Positive screening 24-hour pad weight test (≥100 grams) 6. Experiences at least 3 incontinence episodes per day during baseline diary or presents with continuous incontinence 7. Negative urine culture 8. Willing and able to undergo surgical implantation of the AUS device 9. Willing and able to comply with the follow-up requirements 10. Willing and able to forego any other surgical urinary incontinence treatments while participating in the study 11. Willing and able to sign the informed consent Exclusion Criteria: 1. Previously had or currently has a device implanted (AUS/Sling, or otherwise) for treatment of SUI or urge incontinence 2. Primary urgency incontinence 3. Postvoid residual volume greater that 150 ml or a history of difficulty emptying the bladder 4. Recurrent vesicourethral anastomotic stricture or urethral stricture disease within the past 6 months 5. Known urogenital malignancy other than previously treated prostate cancer 6. Recurrent prostate cancer that is expected to require intervention during the study follow-up period 7. History of recurrent bladder stones within the past 12 months prior to signing the informed consent 8. Neurogenic bladder 9. Need for intermittent catheterization 10. Known history of bleeding diathesis or coagulopathy 11. Immunosuppressed or on medical therapy which would impact the immune system 12. Uncontrolled diabetes, defined as (HbA1c\>10) 13. Has a genitourinary mechanical prosthesis that was implanted within 3 months from the date of consent 14. Had a post-implantation infection associated with the device after genitourinary mechanical prosthesis was implanted 15. Undergone bulking procedure within 6 months of the baseline assessment 16. Poor candidate for surgical procedures and/or anesthesia due to physical or mental conditions 17. Urinary incontinence due to or complicated by an irreversibly obstructed lower urinary tract 18. Irresolvable detrusor hyperreflexia or bladder instability 19. Currently enrolled or plans to enroll in another device or drug clinical trial 20. 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 21. Known allergy or sensitivity to rifampin or to minocycline HCl or other tetracyclines (only applicable when implanting with InhibiZone version of this device) 22. Systemic lupus erythematosus because minocycline HCl has been reported to aggravate this condition (only applicable when implanting with InhibiZone version of this device)

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Conditions

The condition(s) this trial relates to.

female stress incontinence Urinary Incontinence, Stress

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stress urinary incontinence

Contacts and locations

Locations

  • Australian Urology Associates

    Melbourne, Victoria, 3144, Australia

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139, Australia

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Lahey Clinic Hospital

    Burlington, Massachusetts, 01805, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030, United States

  • University of California, San Francisco

    San Francisco, California, 94110, United States

  • University of Colorado Hospital

    Aurora, Colorado, 80045, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Kansas Hospital

    Kansas City, Kansas, 66160-7234, United States

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • Urology San Antonio Research, PA.

    San Antonio, Texas, 78229, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27103, United States

  • Willis-Knighton Bossier Medical Center

    Bossier City, Louisiana, 71111, United States

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