Transcorporal Versus Standard Artificial Urinary Sphincter Placement

Stopped early · Not applicable

Conditions studied: Urinary Stress Incontinence

In brief

The investigators 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 the randomized trial, no additional procedures beyond the normal care protocol will be required of the patients. The investigators will conduct the study through an 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: NCT02591381
Run by: University of California, San Francisco
People needed: 3
Starts: 2015-10-01
Expected to finish: 2017-10-01
Last updated by the study team: 2018-05-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

All patients undergoing an AUS procedure would potentially be candidates for the study
Exclusion Criteria: There are several situations in which either a TC or ST procedure would be specifically indicated, and it would be unethical to randomize these patients to the other procedure.
No men without erectile dysfunction
No use of injectable agents into the corporal body
No prior urethral surgery (Prior surgery defined as; urethroplasty, urethral sling, prior AUS placement or explantation, recto-urethral fistula closure)
No current penile prosthesis
No concomitant placement of penile prosthesis at the time of AUS placement
Males under the age of 18, as well as females, are also excluded

Where it is running

University of California San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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