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NCT05428020 · ClinicalTrials.gov registry record · NA
RCT Foley Catheter Study for Elective TJA
A NA study of Total Knee Arthroplasty and Total Hip Arthroplasty, sponsored by Rush University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 388
- Enrollment target
- 1
- Study location
NCT05428020: Completed NA study of Total Knee Arthroplasty and Total Hip Arthroplasty, sponsored by Rush University Medical Center.
NCT05428020 is a NA study of Total Knee Arthroplasty and Total Hip Arthroplasty that has completed, run by Rush University Medical Center. The registered enrollment target is 388 participants, above the 282-participant average among 29 other Total Knee Arthroplasty trials with a reported enrollment target (38% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05428020, a NA study of Total Knee Arthroplasty and Total Hip Arthroplasty, has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 388 participants
- Enrollment target
- 1
- Study location
Study Summary
Urinary retention is a known complication following surgical procedures, with a theoretical increased risk in patients receiving neuraxial anesthesia due to a decreased ability to sense bladder distension. Urinary retention is associated with adverse events including bladder atony, increased post void residuals, and postoperative urinary tract infection. Treatment of urinary retention involves intermittent or indwelling urinary catheter placement, both of which are associated with an increased prevalence of postoperative urinary tract infection. There currently is no consensus whether the use of a urinary catheter in elective joint arthroplasty with neuraxial anesthesia decreases the risk of urinary retention. The prevalence of retention reported in the literature varies widely with reports anywhere from 0% to 75% in patients with early removal of a catheter or after procedures performed without a catheter. The goal of this study is to determine whether the routine use of an indwelling urinary catheter decreases the rate of postoperative urinary retention in patients undergoing elective joint arthroplasty.
Primary Outcome
All patients were monitored per hospital protocol for urinary retention. After removal of catheter (control group) and those without (experimental group) upon arrival in the PACU (post anesthesia care unit), patients were given 4 hours to void a volume corresponding to 30ml/hour. If the patient failed to do so, they would have their bladder scanned. Bladder scanned results were all reported by 4 hours after surgery. Patients inability to void a volume corresponding to 30ml/hour AND after straigh
Conditions Studied
Interventions
- DEVICE Indwelling foley catheter
- OTHER No foley catheter
Study Locations (1)
Illinois
- Rush University medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 388 participants |
| Start Date | 2020-11-16 |
| Est. Completion | 2022-11-15 |
| Phase | NA |
What the finished NCT05428020 record still lists
NCT05428020 is an interventional study that assigns participants to a tested intervention. The registered 388 participants enrollment target is mid-sized for trials with a published cap, above the 282-participant average among 29 other Total Knee Arthroplasty trials with a reported enrollment target (38% higher).
The record links to 3 conditions, with Total Knee Arthroplasty appearing as the primary indexed condition, and to 2 interventions - of which Indwelling foley catheter is the first listed.
NCT05428020 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05428020 about?
NCT05428020 is a clinical study titled "RCT Foley Catheter Study for Elective TJA". Urinary retention is a known complication following surgical procedures, with a theoretical increased risk in patients receiving neuraxial anesthesia due to a decreased ability to sense bladder distension. Urinary retention is associated with adverse events including bladder atony, increased post vo...
What is the current status of trial NCT05428020?
This trial is currently completed. It is a NA study. The enrollment target is 388 participants. The study started on 2020-11-16. Estimated completion is 2022-11-15.
What conditions does trial NCT05428020 study?
This clinical trial studies the following conditions: Total Knee Arthroplasty, Total Hip Arthroplasty, Post-Operative Urinary Retention.
What interventions are being tested in trial NCT05428020?
The interventions under investigation include: Indwelling foley catheter (DEVICE), No foley catheter (OTHER).
Who is sponsoring clinical trial NCT05428020?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05428020 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05428020's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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