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Effect of Catheter on Postoperative Urinary Retention

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ClinicalTrials.gov Identifier: NCT04645264
Recruitment Status : Terminated (PI initiated closure due to limited clinical resources and lack of participation.)
First Posted : November 27, 2020
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
Carla Edwards, 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).

Condition or disease Intervention/treatment Phase
Transforaminal Lumbar Interbody Fusion Device: Foley Catheter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Indwelling Foley Placement, Immediate Post-Operative Straight Catheterization, or No Catheterization on Post-operative Urinary Retention After Transforaminal Lumbar Interbody Fusions
Actual Study Start Date : September 26, 2018
Actual Primary Completion Date : July 10, 2019
Actual Study Completion Date : July 10, 2019

Arm Intervention/treatment
Experimental: Indwelling Foley
Indwelling Foley placed during surgery
Device: Foley Catheter
The patient is catheterized during surgery.

Active Comparator: Straight Catheter
straight catheterization (in-and-out straight catheterization) will take place at the end of the surgery
Device: Foley Catheter
The patient is catheterized during surgery.

No Intervention: No Catheter
Patient is not catheterized



Primary Outcome Measures :
  1. Spontaneous urination [ Time Frame: From date of surgery until the date of hospital discharge, up to 1 month postoperatively ]
    If patient has the ability to spontaneously urinate

  2. Post-void bladder scan [ Time Frame: From date of surgery until the date of hospital discharge, up to 1 month postoperatively ]
    Post-void bladder volume obtained from ultrasound bladder scan

  3. Need for straight catheterization or post-operative indwelling Foley catheter placement [ Time Frame: From date of surgery until the date of hospital discharge, up to 1 month postoperatively ]
    Did patient need straight catheterization due to urinary retention

  4. Initiation of an alpha-1 inhibitor post-operatively [ Time Frame: From date of surgery until the date of hospital discharge, up to 1 month postoperatively ]
    Did patient receive an alpha-1 inhibitor post-operatively?

  5. Urologic consultations for evaluation of post-operative urinary complications [ Time Frame: From date of surgery until the date of hospital discharge, up to 1 month postoperatively ]
    Did patient have a urology consultation?

  6. UTI acquired post-operatively [ Time Frame: 6 weeks ]
    Did the patient acquire a urinary tract infection?

  7. UTI acquired post-operatively [ Time Frame: 12 weeks ]
    Did the patient acquire a urinary tract infection?

  8. UTI acquired post-operatively [ Time Frame: 6 month ]
    Did the patient acquire a urinary tract infection?

  9. Length of hospital stay [ Time Frame: From date of surgery until the date of hospital discharge, up to 1 month postoperatively ]
    How long was the patients post-operative stay?



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645264


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
  Study Documents (Full-Text)

Documents provided by Carla Edwards, Rush University Medical Center:
Informed Consent Form  [PDF] May 12, 2021

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Responsible Party: Carla Edwards, Clinical Research Manger, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04645264    
Other Study ID Numbers: 18080302
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Urinary Retention
Urination Disorders
Urologic Diseases