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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341819
• Other study ID #: COA 126/2560
• Status: Completed
• Phase: N/A
• Start date: November 6, 2017
• Est. completion date: October 25, 2019

Study information

• Verified date: November 2019
• Source: Navamindradhiraj University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: October 25, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Epidural Anesthesia
• Postoperative Urinary Retention
• Urinary Retention
• Urinary Tract Infections

Intervention

Procedure:
• Total knee arthroplasty
A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)
• 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.

Locations

Country	Name	City	State
Thailand	Navamindradhiraj University	Dusit	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Navamindradhiraj University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 hours after surgery and 6 hours after remove urinary catherter
Secondary	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.	7 days after surgery