Foley CatheterizationEDUCaReNCT05359926
Early Versus Delayed Urinary Catheter Removal After Minimally Invasive Lumbar Spine Surgery
A study testing Experimental and Active comparator in people with Foley Catheterization and Ambulation, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foley Catheterization, Ambulation
- What is being tested?
- Experimental and Active comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and older
- Minimally invasive one- or two-level lumbar fusion procedures
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: 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
Read the 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.
- Conditions
- Foley Catheterization, Ambulation
- Being tested
- Experimental, Active comparator
- Keywords
- lumbar spine, foley catheterization, ambulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Early urethral foley removal after the surgery
Active comparatorOther
Delayed urethral foley removal after the surgery
| Study group | Role | What they receive |
|---|---|---|
| Early Urethral Catheter Removal | Experimental | Removal of the urethral catheter in the operating room at the conclusion of surgery Receives: Other: Experimental |
| Delayed Urethral Catheter Removal | Active comparator | Removal of the urethral catheter in next morning after surgery Receives: Other: Active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulation
Time in minutes to ambulation
Measured: After the surgery, postoperative day 1
Secondary outcomes (7)
Facility discharge
Number of subjects discharge to facility
Measured: Average postoperative day 1-3
Home discharge
Number of subjects discharge to home
Measured: Average postoperative day 1-3
Hospital length of stay
Total number of days in the hospital
Measured: 1 to 3 days
Pain medication
Total dose of opioid medication in milligrams used by each subject
Measured: Hospitalization period: postoperative day 1, 2, 3
Urinary catheter reinsertion
Total number of urinary catheter reinsertion
Measured: 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
Total number of urinary tract infection after urinary catheter removal
Measured: 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
Maximum walking distance tolerated in meters by each subject
Measured: Hospitalization period: postoperative day 1, 2, 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start9 Jun 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Why it stopped: Benefits of no foley outweighed enrollment and use of foley.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Foley CatheterizationStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brandon Carlson, MD, MPH, University of Kansas Medical Center
- Investigators
- Brandon Carlson, MD, MPH, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359926
- Sponsor's protocol ID
- STUDY00148694
- Acronym
- EDUCaRe
- Status last verified
- Oct 2024
- First submitted
- 25 Apr 2022
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang J, Shi Z, Duan FF, Fan MX, Yan S, Wei Y, Han B, Lu XM, Tian W. Benefits of Early Ambulation in Elderly Patients Undergoing Lumbar Decompression and Fusion Surgery: A Prospective Cohort Study. Orthop Surg. 2021 Jun;13(4):1319-1326. doi: 10.1111/os.12953. Epub 2021 May 7.
PubMed 33960687Gornitzky AL, Flynn JM, Muhly WT, Sankar WN. A Rapid Recovery Pathway for Adolescent Idiopathic Scoliosis That Improves Pain Control and Reduces Time to Inpatient Recovery After Posterior Spinal Fusion. Spine Deform. 2016 Jul;4(4):288-295. doi: 10.1016/j.jspd.2016.01.001. Epub 2016 Jun 16.
PubMed 27927519Raudenbush BL, Gurd DP, Goodwin RC, Kuivila TE, Ballock RT. Cost analysis of adolescent idiopathic scoliosis surgery: early discharge decreases hospital costs much less than intraoperative variables under the control of the surgeon. J Spine Surg. 2017 Mar;3(1):50-57. doi: 10.21037/jss.2017.03.11.
PubMed 28435918Marsh J, Somerville L, Howard JL, Lanting BA. Significant cost savings and similar patient outcomes associated with early discharge following total knee arthroplasty. Can J Surg. 2019 Feb 1;62(1):20-24. doi: 10.1503/cjs.002118.
PubMed 30265646Park P, Nerenz DR, Aleem IS, Schultz LR, Bazydlo M, Xiao S, Zakaria HM, Schwalb JM, Abdulhak MM, Oppenlander ME, Chang VW. Risk Factors Associated With 90-Day Readmissions After Degenerative Lumbar Fusion: An Examination of the Michigan Spine Surgery Improvement Collaborative (MSSIC) Registry. Neurosurgery. 2019 Sep 1;85(3):402-408. doi: 10.1093/neuros/nyy358.
PubMed 30113686
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Delayed Urinary Catheter Removal After Minimally Invasive Lumbar Spine Surgery: A Randomized-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05359926
- Acronym / sponsor ID
- EDUCaRe / STUDY00148694
- Conditions
- Foley Catheterization, Ambulation
- Keywords
- lumbar spine, foley catheterization, ambulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Benefits of no foley outweighed enrollment and use of foley.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Urethral Catheter Removal | Experimental | Other: ExperimentalRemoval of the urethral catheter in the operating room at the conclusion of surgery |
| Delayed Urethral Catheter Removal | Active comparator | Other: Active comparatorRemoval of the urethral catheter in next morning after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 years and older
- Minimally invasive one- or two-level lumbar fusion procedures
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalEarly urethral foley removal after the surgery | Other | Early Urethral Catheter Removal |
| Active comparatorDelayed urethral foley removal after the surgery | Other | Delayed Urethral Catheter Removal |
Primary outcome
Ambulation
Time frame: After the surgery, postoperative day 1
Time in minutes to ambulation
7 secondary outcomes
Facility discharge
Time frame: Average postoperative day 1-3
Home discharge
Time frame: Average postoperative day 1-3
Hospital length of stay
Time frame: 1 to 3 days
Pain medication
Time frame: 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
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
Physical therapy progression
Time frame: Hospitalization period: postoperative day 1, 2, 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Background: PubMed 33960687Huang J, Shi Z, Duan FF, Fan MX, Yan S, Wei Y, Han B, Lu XM, Tian W. Benefits of Early Ambulation in Elderly Patients Undergoing Lumbar Decompression and Fusion Surgery: A Prospective Cohort Study. Orthop Surg. 2021 Jun;13(4):1319-1326. doi: 10.1111/os.12953. Epub 2021 May 7.
- Background: PubMed 27927519Gornitzky AL, Flynn JM, Muhly WT, Sankar WN. A Rapid Recovery Pathway for Adolescent Idiopathic Scoliosis That Improves Pain Control and Reduces Time to Inpatient Recovery After Posterior Spinal Fusion. Spine Deform. 2016 Jul;4(4):288-295. doi: 10.1016/j.jspd.2016.01.001. Epub 2016 Jun 16.
- Background: PubMed 28435918Raudenbush BL, Gurd DP, Goodwin RC, Kuivila TE, Ballock RT. Cost analysis of adolescent idiopathic scoliosis surgery: early discharge decreases hospital costs much less than intraoperative variables under the control of the surgeon. J Spine Surg. 2017 Mar;3(1):50-57. doi: 10.21037/jss.2017.03.11.
- Background: PubMed 30265646Marsh J, Somerville L, Howard JL, Lanting BA. Significant cost savings and similar patient outcomes associated with early discharge following total knee arthroplasty. Can J Surg. 2019 Feb 1;62(1):20-24. doi: 10.1503/cjs.002118.
- Background: PubMed 30113686Park P, Nerenz DR, Aleem IS, Schultz LR, Bazydlo M, Xiao S, Zakaria HM, Schwalb JM, Abdulhak MM, Oppenlander ME, Chang VW. Risk Factors Associated With 90-Day Readmissions After Degenerative Lumbar Fusion: An Examination of the Michigan Spine Surgery Improvement Collaborative (MSSIC) Registry. Neurosurgery. 2019 Sep 1;85(3):402-408. doi: 10.1093/neuros/nyy358.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandon Carlson, MD, MPH principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental and Active comparator in people with Foley Catheterization and Ambulation, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulation (time frame: After the surgery, postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05359926, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.