NCT04645264

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2019

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

August 31, 2022

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

September 6, 2019

Results QC Date

July 14, 2022

Last Update Submit

September 14, 2022

Conditions

Transforaminal Lumbar Interbody Fusion

Outcome Measures

Primary Outcomes (1)

  • Length of Hospital Stay

    How long was the patients post-operative stay?

    Date of surgery until the date of hospital discharge, up to 1 month

Study Arms (3)

Indwelling Foley

EXPERIMENTAL

Indwelling Foley placed during surgery

Device: Foley Catheter

Straight Catheter

ACTIVE COMPARATOR

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

Device: Foley Catheter

No Catheter

NO INTERVENTION

Patient is not catheterized

Interventions

Foley CatheterDEVICE

The patient is catheterized during surgery.

Indwelling FoleyStraight Catheter

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Results Point of Contact

Title
Kern Singh, MD
Organization
Rush University Medical Center
kern.singh@rushortho.com
(312) 432-2435

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Manger

Study Record Dates

First Submitted

September 6, 2019

First Posted

November 27, 2020

Study Start

September 26, 2018

Primary Completion

July 10, 2019

Study Completion

July 10, 2019

Last Updated

September 16, 2022

Results First Posted

August 31, 2022

Record last verified: 2022-09

Locations

US(1)