Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT04645264 |
Other study ID # |
18080302 |
Secondary ID |
|
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 26, 2018 |
Est. completion date |
July 10, 2019 |
Study information
Verified date |
September 2022 |
Source |
Rush University Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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).
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.