Effect of Catheter on Postoperative Urinary Retention

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-26

Study Completion Date

2019-07-10

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Transforaminal Lumbar Interbody Fusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Indwelling Foley

Indwelling Foley placed during surgery

Group Type EXPERIMENTAL

Foley Catheter

Intervention Type DEVICE

The patient is catheterized during surgery.

Straight Catheter

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

Group Type ACTIVE_COMPARATOR

Foley Catheter

Intervention Type DEVICE

The patient is catheterized during surgery.

No Catheter

Patient is not catheterized

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Foley Catheter

The patient is catheterized during surgery.

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes