Skip to content

RCT Foley Catheter Study for Elective TJA

The Use of a Routine Indwelling Urinary Catheter in Patients Receiving Neuraxial Anesthesia for Elective Total Joint Arthroplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05428020
Enrollment
388
Registered
2022-06-22
Start date
2020-11-16
Completion date
2022-11-15
Last updated
2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Urinary Retention, Total Hip Arthroplasty, Total Knee Arthroplasty

Keywords

total knee arthroplasty, total hip arthroplasty, indwelling catheter, Foley catheter, arthroplasty

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.

Detailed description

Study Design Treatment Groups: Group 1 (Control): Short term urinary catheter- Patient will receive a urinary catheter at the time of the surgery. The urinary catheter will be removed upon arrival to the orthopedic floor post operatively. Patients will subsequently be monitored for urinary retention according to the Rush University Medical Center urinary retention protocol. Group 2 (Experimental): No urinary catheter- Patients will not receive a urinary catheter at time of surgery. They will be monitored for urinary retention according to the Rush University Medical Center urinary retention protocol Sample Size Calculation Based on a randomized controlled trial published by Miller et al in 2013, to detect a clinically significant difference of 7%, we would need 194 patients per group, or 388 patients. Assuming a drop-out rate of 10%, a total of 432 patients will be required. An interim analysis will be performed once half of this total is enrolled. Urinary retention protocol: Patients will be monitored closely for urinary retention according to current Rush University Medical Center Urinary Retention Protocol. After removal of catheter (control group) or from arrival in post-anesthesia care unit (experimental group), patients will be given 4 hours to void a volume corresponding to 30ml/hour. If the patient fails to do so, they will be bladder scanned. Bladder scan results of 450ml or greater will result in one time straight catheterization. If bladder scan shows 150 ml to 349 ml of urine, patients will be given an additional 4 hours to void and a repeat bladder scan will be performed. If unable to void at this point and/or bladder volume is \>450, patient will receive a one time straight catheterization. If bladder scan shows 350 ml to 449 ml of urine, patients will be given an additional 2 hours to void and a repeat bladder scan performed. If unable to void at this point and/or bladder volume is \>450, patient will receive a one time straight catheterization. If patients require a straight catheterization, they will be monitored with bladder scan according to protocol and a second straight catheterization will be performed if necessary. At time of second straight catheterization, a urinalysis will be sent. If patient requires a third straight catheterization, a urology consult will be placed according to protocol and patient will either receive an indwelling urinary catheter or intermittent straight catheterization with urology follow up. Demographics, Patient Specifics Age, sex, short form 12 scores, american society of anesthesia (ASA) score, medical co-morbidities, weight, height, length of hospitalization, BMI, history of benign prostatic hypertrophy, presence of preoperative urinary tract infection (diagnosed during preadmission testing), intravenous fluids given during surgery, operating room time, estimated blood loss, length of hospital stay, discharge destination (home versus rehabilitation facility), time to mobilization postoperatively, and length of urinary catheter usage. At the time of enrollment in the study, patients will be given a urinary history questionnaire known as the International Prostate Symptom Score (I-PSS) and be asked about history of urinary retention, history of incontinence, and history of polyuria to screen for preexisting urinary issues. Patients will receive a urinalysis as part of preoperative testing to screen for presence of urinary tract infection. Patients will receive standardized multimodal analgesic regimen that is utilized at Rush University Medical Center for patients undergoing a total joint replacement for perioperative and postoperative pain management. Modifications will be made on a case by case basis as is currently the standard practice (for example, allergy, intolerance, or medical contraindication such as acute kidney injury to NSAID use)

Interventions

DEVICEIndwelling 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).

No foley catheter is placed for surgery

Sponsors

Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

The participant (patient) will be blinded to whether they are receiving a short-term foley catheter or no foley.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients Who Developed Postoperative Urinary Retention (POUR), Unable to Void a Volume Greater Than or Equal to 30ml/hrWhile inpatient following surgeryAll 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.

Secondary

MeasureTime frameDescription
Urinary Tract Infections (UTI) as Complication up to 3 Weeks Following Total Joint Arthroplastyup to 3 weeks after surgeryPatients who are treated following Total Joint Arthroplasty for UTI
Straight Catheterization Required While Inpatient Following Total Joint ArthroplastyWhile inpatient at hospital, immediately following surgeryPatient requires 1 or more straight catheterization while inpatient, due to inability to void 30ml/hr during the patient's hospital stay. Straight catheterizations are performed by placing an indwelling catheter when indicated by retention of ≥450 mL on bladder scans. Bladder scans are performed per hospital protocol for patients unable to void a volume of 30ml/hr in the first 4 hours following surgery. If bladder shows 150 ml to 349 ml of urine, patients are given another 4 hours to void, followed by a repeat bladder scan. If unable to void at that time, or bladder volume is \>450ml, patient will receive one-time catheterization. If bladder scan shows 350 ml to 449 ml of urine, they will be given 2 hours to void and repeat bladder scan. If unable to void or bladder volume is \>450 ml, patient receives one time catheterization. If patient receives straight catheterization, they're monitored according to protocol and a second straight catheterization is done if necessary.

Countries

United States

Participant flow

Participants by arm

ArmCount
Indwelling Foley Catheter
Short-term indwelling foley catheter 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).
194
No Foley Catheter
No foley catheter No foley catheter: No foley catheter is placed for surgery
194
Total388

Baseline characteristics

CharacteristicNo Foley CatheterIndwelling Foley CatheterTotal
Age, Continuous67.12 years67.36 years67.24 years
Race/Ethnicity, Customized
Race
Asian
4 Participants4 Participants8 Participants
Race/Ethnicity, Customized
Race
Black/African American
32 Participants46 Participants78 Participants
Race/Ethnicity, Customized
Race
White/caucasion
158 Participants144 Participants302 Participants
Region of Enrollment
United States
194 participants194 participants388 participants
Sex: Female, Male
Female
120 Participants125 Participants245 Participants
Sex: Female, Male
Male
74 Participants69 Participants143 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1940 / 194
other
Total, other adverse events
0 / 1940 / 194
serious
Total, serious adverse events
0 / 1940 / 194

Outcome results

Primary

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.

Time frame: While inpatient following surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Indwelling Foley CatheterNumber of Patients Who Developed Postoperative Urinary Retention (POUR), Unable to Void a Volume Greater Than or Equal to 30ml/hr4 Participants
No Foley CatheterNumber of Patients Who Developed Postoperative Urinary Retention (POUR), Unable to Void a Volume Greater Than or Equal to 30ml/hr5 Participants
Secondary

Straight Catheterization Required While Inpatient Following Total Joint Arthroplasty

Patient requires 1 or more straight catheterization while inpatient, due to inability to void 30ml/hr during the patient's hospital stay. Straight catheterizations are performed by placing an indwelling catheter when indicated by retention of ≥450 mL on bladder scans. Bladder scans are performed per hospital protocol for patients unable to void a volume of 30ml/hr in the first 4 hours following surgery. If bladder shows 150 ml to 349 ml of urine, patients are given another 4 hours to void, followed by a repeat bladder scan. If unable to void at that time, or bladder volume is \>450ml, patient will receive one-time catheterization. If bladder scan shows 350 ml to 449 ml of urine, they will be given 2 hours to void and repeat bladder scan. If unable to void or bladder volume is \>450 ml, patient receives one time catheterization. If patient receives straight catheterization, they're monitored according to protocol and a second straight catheterization is done if necessary.

Time frame: While inpatient at hospital, immediately following surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Indwelling Foley CatheterStraight Catheterization Required While Inpatient Following Total Joint Arthroplasty10 Participants
No Foley CatheterStraight Catheterization Required While Inpatient Following Total Joint Arthroplasty14 Participants
Secondary

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

Patients who are treated following Total Joint Arthroplasty for UTI

Time frame: up to 3 weeks after surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Indwelling Foley CatheterUrinary Tract Infections (UTI) as Complication up to 3 Weeks Following Total Joint Arthroplasty3 Participants
No Foley CatheterUrinary Tract Infections (UTI) as Complication up to 3 Weeks Following Total Joint Arthroplasty1 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026