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NCT02486653 · ClinicalTrials.gov registry record · Phase 3
Prevention of Post-operative Urinary Retention
A Phase 3 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 3
- Development phase
- 158
- Enrollment target
NCT02486653: Completed Phase 3 study, sponsored by University of Wisconsin, Madison.
NCT02486653 is a Phase 3 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 158 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02486653, a Phase 3 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 158 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if tamsulosin ("FLOMAX") is effective in preventing post-operative urinary retention following abdominal surgery. Post-operative urinary retention is a common post-operative complication, occurring in up to 30% of patients undergoing abdominal surgery. It can be described as the inability to initiate urination or properly empty one's bladder following surgery. It is usually self-limited, but it requires the use of catheterization to empty the bladder in order to prevent further injury to the bladder or kidneys and to relief the discomfort of a full bladder. Tamsulosin is a medication that is commonly used in men with urinary symptoms related to an enlarged prostate. There is some evidence to suggest that it may also potentially be beneficial for preventing post-operative urinary retention. Therefore, in this research study, subjects scheduled for abdominal surgery will be randomly assigned to take either tamsulosin once-daily or placebo once-daily for one week leading up to surgery, and up to several days after surgery. Urinary function will be assessed and compared between these two treatments. The hypothesis is that tamsulosin will reduce the rate of postoperative urinary retention compared to placebo.
Primary Outcome
need for any intermittent catheterization after leaving the operating room or after initial indwelling urinary catheter (IUC) removal; subjects will be straight catheterized if the subject either 1) reports bladder discomfort, or 2) has a bladder scan for \>500milliliters; or 3) has a post-void residual volume \>500milliliters
Interventions
- DRUG Placebo
- DRUG Tamsulosin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2015-08 |
| Est. Completion | 2018-05-02 |
| Phase | Phase 3 |
What the finished NCT02486653 record still lists
NCT02486653 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02486653 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02486653 about?
NCT02486653 is a clinical study titled "Prevention of Post-operative Urinary Retention". The purpose of this study is to determine if tamsulosin ("FLOMAX") is effective in preventing post-operative urinary retention following abdominal surgery. Post-operative urinary retention is a common post-operative complication, occurring in up to 30% of patients undergoing abdominal surgery. It ca...
What is the current status of trial NCT02486653?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 158 participants. The study started on 2015-08. Estimated completion is 2018-05-02.
What interventions are being tested in trial NCT02486653?
The interventions under investigation include: Placebo (DRUG), Tamsulosin (DRUG).
Who is sponsoring clinical trial NCT02486653?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02486653's enrollment target sits among peer trials
158 1502nd of 2000 higher than 496 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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