Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 3 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02591381
The ClinicalTrials.gov registry entry for NCT02591381 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Artificial Urinary Sphincter Placement is the first listed.
NCT02591381 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.