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

Sponsor

Navamindradhiraj University (Other)

Overall Status

Completed

CT.gov ID

NCT03341819

Collaborator

(none)

242

Enrollment

Location

Arms

23.6

Actual Duration (Months)

10.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Urinary Retention Urinary Tract Infections Epidural Anesthesia	Procedure: Total knee arthroplasty Procedure: Urinary Catheterization	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

242 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 6, 2017

Actual Primary Completion Date :

Apr 5, 2019

Actual Study Completion Date :

Oct 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Retained Urinary Catheter	Procedure: Total knee arthroplasty A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses) Procedure: Urinary Catheterization 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.
Experimental: Non-retained Urinary Catheter	Procedure: Total knee arthroplasty A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)

Arm

Intervention/Treatment

Active Comparator: Retained Urinary Catheter

Procedure: Total knee arthroplasty

A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)

Procedure: Urinary Catheterization

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.

Experimental: Non-retained Urinary Catheter

Procedure: Total knee arthroplasty

A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)

Outcome Measures

Primary Outcome Measures

postoperative urinary retention [6 hours after surgery and 6 hours after remove urinary catherter]
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 [7 days after surgery]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Navamindradhiraj University	Dusit	Bangkok	Thailand	10300

Sponsors and Collaborators

Navamindradhiraj University

Investigators

Principal Investigator: Satit Thiengwittayaporn, M.D., Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Satit Thiengwittayaporn, Associate Professor, Navamindradhiraj University

ClinicalTrials.gov Identifier:

NCT03341819

Other Study ID Numbers:

COA 126/2560

First Posted:

Nov 14, 2017

Last Update Posted:

Nov 25, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urinary Tract Infections

Urinary Retention

Study Results

No Results Posted as of Nov 25, 2019