RCT Foley Catheter Study for Elective TJA

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

388 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2022-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Compare CAUTI Rates Following ERASE CAUTI Tray Non-Silver vs Silver Coated Foley Catheters

NCT02101762

Surgery Intensive Care Units

TERMINATED

Early or Late Foley Removal After Thoracotomy

NCT01611519

Urinary Tract Infections

COMPLETED

A Trial of Different Methods for Bladder Drainage in Hip Surgery Patients

NCT01333254

Urinary Tract Infections

COMPLETED NA

Ultrasound Guided Repositioning of a New Suture-Method Catheter for Adductor Canal Block

NCT03315481

Anesthesia Pain, Postoperative Pain +1 more

COMPLETED NA

Skin to Adductor Canal Distance in Various Positions

NCT03562559

Knee Arthritis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Urinary Retention Total Hip Arthroplasty Total Knee Arthroplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Indwelling foley catheter

Short-term indwelling foley catheter

Group Type EXPERIMENTAL

Indwelling foley catheter

Intervention Type 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).

No Foley catheter

No foley catheter

Group Type PLACEBO_COMPARATOR

No foley catheter

Intervention Type OTHER

No foley catheter is placed for surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DEVICE

No foley catheter

No foley catheter is placed for surgery

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

foley

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes