RCT Foley Catheter Study for Elective TJA

NCT05428020 | Completed Results FDA Device

• 1 other identifier: 19123101
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

total knee arthroplasty; total hip arthroplasty; indwelling catheter; Foley catheter; arthroplasty

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Developed Postoperative Urinary Retention (POUR), Unable to Void a Volume Greater Than or Equal to 30ml/hr

  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 straight catheterization (per hospital protocol), meant they developed POUR following surgery.

  While inpatient following surgery

Secondary Outcomes (2)

• Urinary Tract Infections (UTI) as Complication up to 3 Weeks Following Total Joint Arthroplasty

  up to 3 weeks after surgery

• Straight Catheterization Required While Inpatient Following Total Joint Arthroplasty

  While inpatient at hospital, immediately following surgery

Study Arms (2)

Indwelling foley catheter

EXPERIMENTAL

Short-term indwelling foley catheter

Device: Indwelling foley catheter

No Foley catheter

PLACEBO COMPARATOR

No foley catheter

Other: No foley catheter

Interventions

Indwelling foley catheter DEVICE

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).

Also known as: foley

Indwelling foley catheter

No foley catheter OTHER

No foley catheter is placed for surgery

No Foley catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient \>18 years of age scheduled for an inpatient primary hip or knee replacement

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (7)

• Balderi T, Carli F. Urinary retention after total hip and knee arthroplasty. Minerva Anestesiol. 2010 Feb;76(2):120-30.

  PMID: 20150853 BACKGROUND

• Lo E, Nicolle L, Classen D, Arias KM, Podgorny K, Anderson DJ, Burstin H, Calfee DP, Coffin SE, Dubberke ER, Fraser V, Gerding DN, Griffin FA, Gross P, Kaye KS, Klompas M, Marschall J, Mermel LA, Pegues DA, Perl TM, Saint S, Salgado CD, Weinstein RA, Wise R, Yokoe DS. Strategies to prevent catheter-associated urinary tract infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008 Oct;29 Suppl 1:S41-50. doi: 10.1086/591066. No abstract available.

  PMID: 18840088 BACKGROUND

• Farag E, Dilger J, Brooks P, Tetzlaff JE. Epidural analgesia improves early rehabilitation after total knee replacement. J Clin Anesth. 2005 Jun;17(4):281-5. doi: 10.1016/j.jclinane.2004.08.008.

  PMID: 15950853 BACKGROUND

• Borghi B, Agnoletti V, Ricci A, van Oven H, Montone N, Casati A. A prospective, randomized evaluation of the effects of epidural needle rotation on the distribution of epidural block. Anesth Analg. 2004 May;98(5):1473-8, table of contents. doi: 10.1213/01.ane.0000111113.45743.b8.

  PMID: 15105234 BACKGROUND

• Miller AG, McKenzie J, Greenky M, Shaw E, Gandhi K, Hozack WJ, Parvizi J. Spinal anesthesia: should everyone receive a urinary catheter?: a randomized, prospective study of patients undergoing total hip arthroplasty. J Bone Joint Surg Am. 2013 Aug 21;95(16):1498-503. doi: 10.2106/JBJS.K.01671.

  PMID: 23965700 BACKGROUND

• Anger J, Lee U, Ackerman AL, Chou R, Chughtai B, Clemens JQ, Hickling D, Kapoor A, Kenton KS, Kaufman MR, Rondanina MA, Stapleton A, Stothers L, Chai TC. Recurrent Uncomplicated Urinary Tract Infections in Women: AUA/CUA/SUFU Guideline. J Urol. 2019 Aug;202(2):282-289. doi: 10.1097/JU.0000000000000296. Epub 2019 Jul 8.

  PMID: 31042112 BACKGROUND

• Darbyshire D, Rowbotham D, Grayson S, Taylor J, Shackley D. Surveying patients about their experience with a urinary catheter. Int J of Uro Nursing 2016;10(1):14-20.

  BACKGROUND

MeSH Terms

Interventions

Urinary Catheterization

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Urological; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Results Point of Contact

• Title: Anne DeBenedetti, Director of Research, Adult Reconstruction
• Organization: Rush University Medical Center

anne.debenedetti@rushortho.com

3124322468

Study Officials

• Craig Della Valle, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant (patient) will be blinded to whether they are receiving a short-term foley catheter or no foley.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopedic Surgery, Chief Division of Adult Reconstruction

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 22, 2022
• Study Start: November 16, 2020
• Primary Completion: May 25, 2022
• Study Completion: November 15, 2022
• Last Updated: August 3, 2023
• Results First Posted: August 3, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)