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AUSCO Clinical Trial

The Artificial Urinary Clinical Outcomes Clinical Trial is studying the AMS 800™ Artificial Urinary Sphincter (AUS) and its impact on urinary incontinence in men.

The AUSCO trial is currently enrolling patients who plan to receive the AMS 800 in the United States and Australia.

Why AMS 800 AUS?

More than 250,000 devices sold have treated patients with the AMS 800 Artificial Urinary Sphincter.1 Artificial urinary sphincters are the gold standard treatment for male stress urinary incontinence (SUI) following prostate surgery.2-4
 
Male sitting on bed doing a web search on a laptop computer.

Find a Trial Site

For more information, or to find out if you're an appropriate candidate for a clinical trial, select the link below and fill out the find a study form.
Find an Eligible Study
 

Trial Design and Primary Endpoints

Single-arm, prospective, multi-center study with 12-month follow-up.

Primary Endpoint – Treatment success defined as ≥ 50% reduction in 24-hour pad weight test from baseline at 12 months post device activation.

Illustration of 2 middle aged men standing, and 3 silhouettes of men behind them.
 

Trial Timeline (patient timeline)

Screening – Baseline Testing – Procedure – Device Activation – 3 Months, 6 Months, and 12 Months
 

Who is an AUSCO Patient?

grandfather holding 3 year old grandson laughing and having a good time on a couch.
  • Primary SUI, De Novo cases, who have undergone either a radical prostatectomy, transurethral resection of the prostate or other invasive prostate surgery
  • Positive screening 24-hour pad weight test: Greater than or equal to 100-gram
  • Experiences at least 3 incontinence episodes per day during baseline diary
  • No current UI devices or comorbidities (known urogenital cancer, urethral stricture, etc.)
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