Early Versus Delayed Urinary Catheter Removal After Minimally Invasive Lumbar Spine Surgery (EDUCaRe)

September 3, 2025 updated by: Brandon Carlson, MD, MPH, University of Kansas Medical Center

Early Versus Delayed Urinary Catheter Removal After Minimally Invasive Lumbar Spine Surgery: A Randomized-Controlled Clinical Trial

The study aims to compare between early versus delayed urinary catheter removal the impact on time to ambulation (in minutes) after minimally invasive lumbar spine surgery

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Early ambulation enables rapid removal of drainage tubes and canisters and decreases length of hospitalization. Previous article showed that a 1-day shorter in hospitalization led to an approximately US$ 2000 reduction in total patient costs. Another study examining patients after total knee arthroplasty found that an early discharge group, a decrease in length of stay in 22h resulted in financial savings of approximately US$ 600 per case.

Another author found that early ambulation was associated with 19% lower 90-day readmission rate. Moreover, early ambulation contributed to 50.6% lower probability of developing at least one complication than regular ambulation.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18 years and older
  • Minimally invasive one- or two-level lumbar fusion procedures

Exclusion Criteria:

  • Patients that cannot give consent
  • Patients with lower extremity amputation(s);
  • Non-minimally invasive surgeries
  • Patients with pre-existing bladder/kidney or urinary tract dysfunction
  • Patients with spinal cord injuries
  • Patients with known lower extremity weakness and impaired mobility.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Urethral Catheter Removal
Removal of the urethral catheter in the operating room at the conclusion of surgery
Other: Experimental
Early urethral foley removal after the surgery
Active Comparator: Delayed Urethral Catheter Removal
Removal of the urethral catheter in next morning after surgery
Other: Active comparator
Delayed urethral foley removal after the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ambulation
Time Frame: After the surgery, postoperative day 1
Time in minutes to ambulation
After the surgery, postoperative day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facility discharge
Time Frame: Average postoperative day 1-3
Number of subjects discharge to facility
Average postoperative day 1-3
Home discharge
Time Frame: Average postoperative day 1-3
Number of subjects discharge to home
Average postoperative day 1-3
Hospital length of stay
Time Frame: 1 to 3 days
Total number of days in the hospital
1 to 3 days
Pain medication
Time Frame: Hospitalization period: postoperative day 1, 2, 3
Total dose of opioid medication in milligrams used by each subject
Hospitalization period: postoperative day 1, 2, 3
Urinary catheter reinsertion
Time Frame: From date of the surgery until the date of first documented event, whichever came first, assessed up to discharge (1 to 3 days) after the surgery
Total number of urinary catheter reinsertion
From date of the surgery until the date of first documented event, whichever came first, assessed up to discharge (1 to 3 days) after the surgery
Urinary tract infection
Time Frame: From date of the surgery until the date of first documented event, whichever came first, assessed up to 1 month after the surgery
Total number of urinary tract infection after urinary catheter removal
From date of the surgery until the date of first documented event, whichever came first, assessed up to 1 month after the surgery
Physical therapy progression
Time Frame: Hospitalization period: postoperative day 1, 2, 3
Maximum walking distance tolerated in meters by each subject
Hospitalization period: postoperative day 1, 2, 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Brandon Carlson, MD, MPH, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2022

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

April 25, 2022

First Submitted That Met QC Criteria

April 28, 2022

First Posted (Actual)

May 4, 2022

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00148694

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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