Effect of Catheter on Postoperative Urinary Retention

Not Applicable

Terminated

• Conditions: Transforaminal Lumbar Interbody Fusion
• Interventions: Device: Foley Catheter

• Registration Number: NCT04645264
• Lead Sponsor: Rush University Medical Center

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.

Study Timeline

• Study Start: 2018-09-26
• Primary Completion: 2019-07-10
• Study Completion: 2019-07-10
• Study First Submitted: 2019-09-06
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-27
• Results First Submitted: 2022-07-14
• Results First Submitted QC: 2022-08-09
• Results First Posted: 2022-08-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-14
• Last Update Posted: 2022-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indwelling Foley	Foley Catheter	Indwelling Foley placed during surgery
Straight Catheter	Foley Catheter	straight catheterization (in-and-out straight catheterization) will take place at the end of the surgery

Primary Outcome Measures

Name	Time	Method
Length of Hospital Stay	Date of surgery until the date of hospital discharge, up to 1 month	How long was the patients post-operative stay?

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States