A Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement

Withdrawn before enrolling · Not applicable

Conditions studied: Stress Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT02524366

Run by

University of Minnesota

People needed

0

Starts

2015-09-01

Expected to finish

2017-11-01

Last updated by the study team

2019-07-22

Who can join

Age: 18 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Men undergoing an AUS procedure
• History of pelvic radiation for prostate or other cancer
• No spontaneous erections and no erections with oral erectogenic agents
• Subjects able to consent for themselves

You may not qualify if…

• prior urethroplasty
• prior urethral erosion of AUS
• history of penile prosthesis placement or explantation
• concomitant placement of penile prosthesis at the time of AUS placement

Where it is running

• University of Minnesota Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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