Effect of Catheter on Postoperative Urinary Retention

Rush

Status: Terminated

Conditions: Transforaminal Lumbar Interbody Fusion

Treatments: Device: Foley Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT04645264

18080302

Details and patient eligibility

About

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).

Full 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.

Enrollment: 7 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 3 patient groups

Indwelling Foley

Experimental group

Description:

Indwelling Foley placed during surgery

Treatment:

Device: Foley Catheter

Straight Catheter

Active Comparator group

Description:

straight catheterization (in-and-out straight catheterization) will take place at the end of the surgery

Treatment:

Device: Foley Catheter

No Catheter

No Intervention group

Description:

Patient is not catheterized