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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 is a Phase 4 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 164 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03287089
The ClinicalTrials.gov registry entry for NCT03287089 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nitrofurantoin 100 MG is the first listed.
NCT03287089 reports 0 study locations.
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.
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