Artificial Urinary Sphincter Clinical Outcomes

Purpose

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

Criteria

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

Willing and able to undergo surgical implantation of the AUS device

Cannot:

      • Previously had or currently has a device implanted (AUS/Sling, or otherwise) for treatment of SUI or urge incontinence
      • Primary urgency incontinence
      • History of adjuvant or neo-adjuvant radiation therapy, cryotherapy, or high-intensity focused ultrasound therapy
      • 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  
      • History of recurrent bladder stones within the past 12 months  
      • 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
      • Undergone bulking procedure within 6 months of the baseline assessment
      • Poor candidate for surgical procedures and/or anesthesia  
      • 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  
      • Systemic lupus erythematosus

Details

Device is implanted as part of standard of care.  Patient / Insurance is responsible for the procedure and all routine follow-up.  No research specific visits will be done. Patient will be reimbursed for participation

Interested in more information? Contact Us:

Gerard Henry, M.D., Principal Investigator

IRB: WIRB
IRB Number:
Trial Type: Device
Sponsor: Boston Scientific