for males ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
at San Francisco, California and other locations
study started
completion around



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


Stress Urinary Incontinence, Urinary Incontinence, AMS 800 Artificial Urinary Sphincter, AMS 800 Artificial Urinary Sphincter Recipients


You can join if…

Open to males ages 18 years and up

  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

You CAN'T join if...

  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


    17. Urinary incontinence due to or complicated by an irreversibly obstructed lower urinary


    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)


  • UCSF
    San Francisco California 94110 United States
  • University of Utah
    Salt Lake City Utah 84132 United States


in progress, not accepting new patients
Start Date
Completion Date
Boston Scientific Corporation
Study Type
About 144 people participating
Last Updated