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NCT02591381 · ClinicalTrials.gov registry record · NA
Transcorporal Versus Standard Artificial Urinary Sphincter Placement
A NA study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT02591381: Clinical Trial NA study, sponsored by University of California, San Francisco.
NCT02591381 is a NA study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 3 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02591381, a NA study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
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.
Interventions
- PROCEDURE Artificial Urinary Sphincter Placement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2015-10 |
| Est. Completion | 2017-10 |
| Phase | NA |
Why NCT02591381 stopped before completion
NCT02591381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Artificial Urinary Sphincter Placement is the first listed.
NCT02591381 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02591381 about?
NCT02591381 is a clinical study titled "Transcorporal Versus Standard Artificial Urinary Sphincter Placement". 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 ...
What is the current status of trial NCT02591381?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2015-10. Estimated completion is 2017-10.
What interventions are being tested in trial NCT02591381?
The interventions under investigation include: Artificial Urinary Sphincter Placement (PROCEDURE).
Who is sponsoring clinical trial NCT02591381?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02591381's enrollment target sits among peer trials
3 1996th of 2000 higher than 4 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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