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NCT03287089 · ClinicalTrials.gov registry record · Phase 4
Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery
A Phase 4 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 4
- Development phase
- 164
- Enrollment target
NCT03287089: Completed Phase 4 study, sponsored by Wake Forest University Health Sciences.
NCT03287089 is a Phase 4 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 164 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03287089, a Phase 4 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 164 participants
- Enrollment target
Study Summary
The specific aim of this randomized double-blind placebo-controlled trial is to evaluate the efficacy of administration of nitrofurantoin prophylaxis after catheter discontinuation for the prevention of catheter-associated urinary tract infections in patients with postoperative short-term catheterization following pelvic reconstructive surgery and/or urinary incontinence surgery. Patients that undergo pelvic organ prolapse and/or urinary incontinence surgery and fail their post-operative voiding trial will be included in the study. Upon successfully passing and in-office voiding trial at the time of catheter removal, they will be randomized to either nitrofurantoin 100mg twice daily or an identical appearing placebo capsule twice daily for 5 days following catheter removal. The primary outcome will be the treatment of clinically suspected and/or culture-proven UTI within 30 days of surgery. Secondary outcomes include adverse events associated with nitrofurantoin use and medication compliance. Primary and secondary outcomes will be evaluated with Student t test and chi squared or Fisher exact test as appropriate. Assuming a decrease in symptomatic UTIs attributable to nitrofurantoin prophylaxis from 32% to 14%, with 80% power, and a two-sided alpha of 0.05, we should recruit a total of 164 patients.
Primary Outcome
Number of participants with a urinary tract infection in the first 30 days following pelvic reconstructive surgery
Interventions
- DRUG Nitrofurantoin 100 MG
- DRUG Placebo Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2017-09-29 |
| Est. Completion | 2019-06-01 |
| Phase | Phase 4 |
What the finished NCT03287089 record still lists
NCT03287089 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Nitrofurantoin 100 MG is the first listed.
NCT03287089 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03287089 about?
NCT03287089 is a clinical study titled "Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery". The specific aim of this randomized double-blind placebo-controlled trial is to evaluate the efficacy of administration of nitrofurantoin prophylaxis after catheter discontinuation for the prevention of catheter-associated urinary tract infections in patients with postoperative short-term catheteriz...
What is the current status of trial NCT03287089?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 164 participants. The study started on 2017-09-29. Estimated completion is 2019-06-01.
What interventions are being tested in trial NCT03287089?
The interventions under investigation include: Nitrofurantoin 100 MG (DRUG), Placebo Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT03287089?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03287089's enrollment target sits among peer trials
164 496th of 2000 higher than 1,500 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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