An interventional study of Foley Catheter in Transforaminal Lumbar Interbody Fusion, sponsored by Rush University Medical Center. Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-09-16.
Sponsored by Rush University Medical Center · Not applicable, Interventional, and Prevention
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).
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.
Rush University Medical Center is the lead sponsor of 397 studies on the registry; 61 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 26 (84%) have results posted.
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Exclusion Criteria:
Indwelling Foley placed during surgery
Device: Foley Catheter
straight catheterization (in-and-out straight catheterization) will take place at the end of the surgery
Device: Foley Catheter
Patient is not catheterized
The patient is catheterized during surgery.
Length of Hospital Stay
How long was the patients post-operative stay?
Time frame: Date of surgery until the date of hospital discharge, up to 1 month
| Milestone | Indwelling Foley | Straight Catheter | No Catheter |
|---|---|---|---|
| Started | 3 | 2 | 2 |
| Completed | 3 | 2 | 2 |
| Not completed | 0 | 0 | 0 |
How long was the patients post-operative stay?
| days | Indwelling Foley | Straight Catheter | No Catheter |
|---|---|---|---|
| Length of Hospital Stay | 3 (1 to 3) | 2 (1 to 3) | 2 (1 to 3) |
Collected over From the date of surgery to 6 months post-surgical. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Indwelling Foley | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Straight Catheter | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| No Catheter | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Indwelling Foley | Straight Catheter | No Catheter | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 2 | 1 | 5 |
| >=65 years | 1 | 0 | 1 | 2 |
| Age, Continuous(years) | Indwelling Foley | Straight Catheter | No Catheter | Total |
|---|---|---|---|---|
| Mean | 55 (46 to 60) | 57 (55 to 58) | 58 (55 to 66) | 57 (46 to 66) |
| Sex: Female, Male(Participants) | Indwelling Foley | Straight Catheter | No Catheter | Total |
|---|---|---|---|---|
| Female | 2 | 1 | 1 | 4 |
| Male | 1 | 1 | 1 | 3 |
| Race and Ethnicity Not Collected(Participants) | Indwelling Foley | Straight Catheter | No Catheter | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(participants) | Indwelling Foley | Straight Catheter | No Catheter | Total |
|---|---|---|---|---|
| United States | 3 | 2 | 2 | 7 |
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This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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