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NCT01568918 · ClinicalTrials.gov registry record · Phase 3
Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
A Phase 3 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Phase 3
- Development phase
- 90
- Enrollment target
NCT01568918: Clinical Trial Phase 3 study, sponsored by Mayo Clinic.
NCT01568918 is a Phase 3 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 90 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01568918, a Phase 3 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 90 participants
- Enrollment target
Study Summary
Postoperative urinary retention is a frequent complication of spinal surgeries and impacts a large portion of this population which results in increased morbidity as a result of increased number of catheterizations, urinary tract infections (UTIs) and prolonged hospital stays. With the addition of Tamsulosin, the investigators would anticipate a reduction in the incidence and duration of postoperative urinary retention and therefore a reduction in morbidity related to treatment of urinary retention as well as shortened hospital stays.
Primary Outcome
Post operative urinary retention (POUR) will be defined as any of the following: 1\) Estimated post-void residual (PVR) volume of urine greater than or equal to 300 mL; 2) Estimated retention urine volume of greater than or equal to 500 mL in patients unable to void; 3) Patients experiencing discomfort or distension and unable to void with lesser residual urine volume than 500 ml.
Interventions
- OTHER Placebo
- DRUG Tamsulosin hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2012-05 |
| Est. Completion | 2019-11-21 |
| Phase | Phase 3 |
Why NCT01568918 stopped before completion
NCT01568918 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01568918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01568918 about?
NCT01568918 is a clinical study titled "Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery". Postoperative urinary retention is a frequent complication of spinal surgeries and impacts a large portion of this population which results in increased morbidity as a result of increased number of catheterizations, urinary tract infections (UTIs) and prolonged hospital stays. With the addition of T...
What is the current status of trial NCT01568918?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2012-05. Estimated completion is 2019-11-21.
What interventions are being tested in trial NCT01568918?
The interventions under investigation include: Placebo (OTHER), Tamsulosin hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01568918?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01568918's enrollment target sits among peer trials
90 1724th of 2000 higher than 263 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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