Back to resultsEffect of Catheter on Postoperative Urinary Retention
Primary Purpose
Transforaminal Lumbar Interbody Fusion
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Foley Catheter
Sponsored by
About this trial
This is an interventional prevention trial for Transforaminal Lumbar Interbody Fusion
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing a primary single-level MIS TLIF (Diagnosis: radiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, spondylolysis, spondylolisthesis)
- Patients able to provide informed consent
Exclusion Criteria:
- Patients with baseline urinary dysfunction requiring manual bladder emptying via intermittent straight catheterization, suprapubic catheters, or other indwelling catheters. -Allergies or other contraindications to medicines in the post- operative urinary retention protocol
- Lack of consent
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Indwelling Foley
Straight Catheter
No Catheter
Arm Description
Indwelling Foley placed during surgery
straight catheterization (in-and-out straight catheterization) will take place at the end of the surgery
Patient is not catheterized
Outcomes
Primary Outcome Measures
Length of Hospital Stay
How long was the patients post-operative stay?
Secondary Outcome Measures
Full Information
NCT ID
NCT04645264
First Posted
September 6, 2019
Last Updated
September 14, 2022
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04645264
Brief Title
Effect of Catheter on Postoperative Urinary Retention
Official Title
Effect of Indwelling Foley Placement, Immediate Post-Operative Straight Catheterization, or No Catheterization on Post-operative Urinary Retention After Transforaminal Lumbar Interbody Fusions
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
PI initiated closure due to limited clinical resources and lack of participation.
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
July 10, 2019 (Actual)
Study Completion Date
July 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
To determine if indwelling Foley placement at the onset of the procedure, straight catherization at the conclusion of the procedure, or no catheterization produces the lowest rates of postoperative urinary retention after transforaminal lumbar interbody fusions (TLIFs).
Detailed Description
Post-operative urinary retention (POUR) is one the most common post-operative complications after elective spine surgeries. Common causes of postoperative urinary retention (POUR) include bladder stenosis, distension, trauma due to catheterizations, age, and prostate hyperplasia. The incidence of POUR increases with age, gender, types of surgery conducted, any comorbidities such as cerebral palsy or multiple sclerosis, use of drugs such as anticholinergic agents, beta blockers, or sympathomimetics, and use of IV fluids.
This condition has been associated with the development of UTIs and sepsis, increased post-operative length of stay (LOS), and 90-day readmission after surgery. In the field of spine surgery, the reported incidence of POUR is highly variable, and there is no consensus on effective methods of prevention. We set out to assess POUR from patients catheterized compared to non-catheterized following a transforaminal lumbar interbody fusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transforaminal Lumbar Interbody Fusion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Indwelling Foley
Arm Type
Experimental
Arm Description
Indwelling Foley placed during surgery
Arm Title
Straight Catheter
Arm Type
Active Comparator
Arm Description
straight catheterization (in-and-out straight catheterization) will take place at the end of the surgery
Arm Title
No Catheter
Arm Type
No Intervention
Arm Description
Patient is not catheterized
Intervention Type
Device
Intervention Name(s)
Foley Catheter
Intervention Description
The patient is catheterized during surgery.
Primary Outcome Measure Information:
Title
Length of Hospital Stay
Description
How long was the patients post-operative stay?
Time Frame
Date of surgery until the date of hospital discharge, up to 1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients undergoing a primary single-level MIS TLIF (Diagnosis: radiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, spondylolysis, spondylolisthesis)
Patients able to provide informed consent
Exclusion Criteria:
Patients with baseline urinary dysfunction requiring manual bladder emptying via intermittent straight catheterization, suprapubic catheters, or other indwelling catheters. -Allergies or other contraindications to medicines in the post- operative urinary retention protocol
Lack of consent
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
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Effect of Catheter on Postoperative Urinary Retention
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