A Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement

Summary

We propose a randomized non-blinded comparison of standard vs. transcorporal approach for placement of an artificial urinary sphincter in male patients with stress urinary incontinence after radiation and radical prostatectomy for prostate cancer. In the United States, the artificial urinary sphincter (AUS), manufactured by American Medical Systems, is the gold standard surgical treatment for stress urinary incontinence (SUI) in men. The cuff, which is the portion of the device that encircles and occludes the urethra, is typically placed directly around the urethra (i.e., "standard" placement). The cuff can erode into the urethra. Transcorporal placement has been introduced as a method to reduce the risk of erosion. Transcorporal placement involves tunneling the cuff through the erectile bodies so as to protect the dorsal aspect of the urethra. This approach has never been compared to standard placement in a randomized fashion. In our randomized trial, no additional procedures beyond the normal care protocol will be required of the patients. We will conduct the study through our established, IRB-approved multi-institutional network of surgeons. Success will be assessed via objective and subjective methods; complications will be tallied in a standardized fashion. Outcomes will be measured at two years.

Conditions

• Stress Urinary Incontinence

Interventions

DEVICE

Artificial Urinary Sphincter

Sponsors & Collaborators

• Baylor College of Medicine

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• University of Kansas

  collaborator OTHER

• Loyola University Chicago

  collaborator OTHER

• Lahey Clinic

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of Washington

  collaborator OTHER

• New York University

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• University of Minnesota

  lead OTHER

Principal Investigators

• Sean Elliott, MD · University of Minnesota

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2017-11-30

Completion

2017-11-30

FDA Device

Yes

Countries

• United States

Study Locations