search
Back to results

Comparative Study Between Retained and Non-retained Urinary Catheter in Total Knee Arthorplasty With Epidural Anesthesia

Primary Purpose

Postoperative Urinary Retention, Urinary Tract Infections, Epidural Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Total knee arthroplasty
Urinary Catheterization
Sponsored by
Navamindradhiraj University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Urinary Retention

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty

Exclusion Criteria:

  • History of renal disease
  • History of urinary tract infection
  • History of previous urinary tract surgery
  • Benign prostatic hypertrophy
  • Bilateral total knee arthroplasty
  • Revision total knee arthroplasty
  • Patients who need intraoperative monitoring of urine output

Sites / Locations

  • Navamindradhiraj University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Retained Urinary Catheter

Non-retained Urinary Catheter

Arm Description

Outcomes

Primary Outcome Measures

postoperative urinary retention
Patients who didn't void within 6 hours with suprapubic discomfort and had a urinary volume 400 mL or more confirmed by single intermittent catheterization

Secondary Outcome Measures

urinary tract infection
An infection of the kidney, ureter, bladder, or urethra. The symptoms are burning with urination and having to urinate frequently and fever > 38° C. Urine culture shows a bacterial colony count of greater than or equal to ten to the fifth colony-forming units per mL of a typical urinary tract organism.

Full Information

First Posted
November 9, 2017
Last Updated
November 22, 2019
Sponsor
Navamindradhiraj University
search

1. Study Identification

Unique Protocol Identification Number
NCT03341819
Brief Title
Comparative Study Between Retained and Non-retained Urinary Catheter in Total Knee Arthorplasty With Epidural Anesthesia
Official Title
Comparative Study Between Retained and Non-retained Urinary Catheter in Total Knee Arthorplasty With Epidural Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
October 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Navamindradhiraj University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the prevalence of postoperative urinary retention between retained and non-retained urinary catheter in total knee arthorplasty with epidural anesthesia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Urinary Retention, Urinary Tract Infections, Epidural Anesthesia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retained Urinary Catheter
Arm Type
Active Comparator
Arm Title
Non-retained Urinary Catheter
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Total knee arthroplasty
Intervention Description
A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)
Intervention Type
Procedure
Intervention Name(s)
Urinary Catheterization
Intervention Description
Urinary catheterization is a latex, polyurethane, or silicone tube known as a urinary catheter is inserted into a patient's bladder via the urethra. Catheterization allows the patient's urine to drain freely from the bladder for collection.
Primary Outcome Measure Information:
Title
postoperative urinary retention
Description
Patients who didn't void within 6 hours with suprapubic discomfort and had a urinary volume 400 mL or more confirmed by single intermittent catheterization
Time Frame
6 hours after surgery and 6 hours after remove urinary catherter
Secondary Outcome Measure Information:
Title
urinary tract infection
Description
An infection of the kidney, ureter, bladder, or urethra. The symptoms are burning with urination and having to urinate frequently and fever > 38° C. Urine culture shows a bacterial colony count of greater than or equal to ten to the fifth colony-forming units per mL of a typical urinary tract organism.
Time Frame
7 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty Exclusion Criteria: History of renal disease History of urinary tract infection History of previous urinary tract surgery Benign prostatic hypertrophy Bilateral total knee arthroplasty Revision total knee arthroplasty Patients who need intraoperative monitoring of urine output
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satit Thiengwittayaporn, M.D.
Organizational Affiliation
Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Navamindradhiraj University
City
Dusit
State/Province
Bangkok
ZIP/Postal Code
10300
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33180187
Citation
Thiengwittayaporn S, Uthaitas P, Hongku N, Tunyasuwanakul R, Limphunudom P, Leelachiewchankul F. Indwelling urinary catheterization was unnecessary in non-drainage total knee arthroplasty: a randomized controlled trial. Arch Orthop Trauma Surg. 2021 Mar;141(3):469-476. doi: 10.1007/s00402-020-03677-z. Epub 2020 Nov 12.
Results Reference
derived

Learn more about this trial

Comparative Study Between Retained and Non-retained Urinary Catheter in Total Knee Arthorplasty With Epidural Anesthesia

We'll reach out to this number within 24 hrs