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RCT Foley Catheter Study for Elective TJA

NCT05428020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2023-08-03

Study results available
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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.

Conditions

  • Postoperative Urinary Retention
  • Total Hip Arthroplasty
  • Total Knee Arthroplasty

Interventions

DEVICE

Indwelling foley catheter

short-term indwelling catheter inserted in the operating room prior to surgery, removed upon arrival to the floor from post-anesthesia care unit (approx 2-3 hours after surgery).

OTHER

No foley catheter

No foley catheter is placed for surgery

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Craig Della Valle, MD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-16
Primary Completion
2022-05-25
Completion
2022-11-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05428020 on ClinicalTrials.gov