N/A
N=388
RCT Foley Catheter Study for Elective TJA
Postoperative Urinary Retention · Total Hip Arthroplasty · Total Knee Arthroplasty
Bottom Line
View on ClinicalTrials.gov: NCT05428020 ↗Enrolled (actual)
388
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Number of Patients Who Developed Postoperative Urinary Retention (POUR), Unable to Void a Volume Greater Than or Equal to 30ml/hr — 4; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Indwelling foley catheter (Device); No foley catheter (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Developed Postoperative Urinary Retention (POUR), Unable to Void a Volume Greater Than or Equal to 30ml/hr |
4; 5 | — |
| SECONDARY Urinary Tract Infections (UTI) as Complication up to 3 Weeks Following Total Joint Arthroplasty |
3; 1 | — |
| SECONDARY Straight Catheterization Required While Inpatient Following Total Joint Arthroplasty |
10; 14 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Any patient >18 years of age scheduled for an inpatient primary hip or knee replacement
Exclusion Criteria
- Patients with a known history of prostate, urological or kidney surgery
- Patients where close monitoring of urine output are necessary during the perioperative period (renal disease, renal failure, chronic indwelling urinary catheter)
- Patients with a history of urinary incontinence
- Patients undergoing a revision total knee or total hip arthroplasty
- Patients requiring indwelling continuous epidural anesthesia
- Patients with a preexisting urinary tract infection, as diagnosed on preoperative screening.
Data sourced from ClinicalTrials.gov (NCT05428020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.