Urinary Retention After Arthroplasty (UREA)

Urinary Retention After Arthroplasty - UREA Trial

Arthroplasty increases the risk of postoperative urinary retention. Treatment of postoperative urinary retention is indwelling or intermittent catheterization. The need for catheterization is most commonly determined with an ultrasound scanner. Catheterization increases the risk of urinary tract infection, which may further lead to haematogenic infection of the artificial joint. There is no evidence of an optimal way to monitor the onset of spontaneous urination.

The aim of the study is to determine whether monitoring the onset of spontaneous urination after fast track knee arthroplasty is safe based on symptoms alone without ultrasound monitoring.

Study Overview

• Status: Recruiting
• Conditions: Arthroplasty Complications; Urinary Retention Postoperative
• Intervention / Treatment: Other: Catheterization based on ultrasound; Other: Catheterization based on evaluation of symptoms

Detailed Description

Adult patients undergoing knee arthroplasty will be recruited to this study. Participants will be randomized to the ultrasound monitoring group or the symptoms alone group. In the symptoms alone group, urination is monitored by asking at regular intervals about the onset of spontaneous urination and the patient is catheterized only on a symptomatic basis or if spontaneous voiding has not started 10 hours after the spinal anesthesia. Symptoms that indicate catheterization are lower abdominal pain or need to void. In the ultrasound group, urinary retention is monitored according to current practice with an ultrasound scanner and the patient is catheterized if residual urine exceeds 800 ml or if the patient is symptomatic.

The primary outcome variable is the change in IPSS score from the baseline to 3 months after the procedure. The baseline score is evaluated preoperatively.

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juha Paloneva, professor; Phone Number: 014 269 1680; Email: juha.paloneva@ksshp.fi
• Study Contact Backup: Name: Juho Sippola, MD; Phone Number: 014 269 1908; Email: juho.sippola@ksshp.fi

Study Locations

• Finland
  • Jyväskylä, Finland, 40620
    • Recruiting
    • Central Finland Hospital Nova
    • Contact: Juho Sippola, MD; Phone Number: +358 14 2691908
    • Contact: Juha Paloneva, MD, PhD; Phone Number: +358 14 2693119

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• elective total knee arthroplasty

Exclusion Criteria:

• previous surgery for urologic cancer
• fracture as indication for surgery
• lack of co-operation
• untreated urinary retention
• nephrostoma
• general anesthesia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound monitoring group; In the ultrasound group, urinary retention is monitored, according to current practice, with an ultrasound scanner and the patient is catheterized if necessary, if residual urine exceeds 800 ml, or if the patient is symptomatic.	Other: Catheterization based on ultrasound; Bladder volume ultrasound
Active Comparator: Symptoms alone group; Urination is monitored by asking at regular intervals about the onset of spontaneous urination and the patient is catheterized only on a symptomatic basis.	Other: Catheterization based on evaluation of symptoms; Ask for symptoms: Need to urinate, lower abdominal pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Prostate Symptom Score (IPSS)	IPSS questionnaire compared to IPSS before surgery. The minimum score is 0. The maximum score is 35. Higher scores mean a worse outcome.	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Prostate Symptom Score (IPSS)	IPSS questionnaire compared to IPSS before surgery. The minimum score is 0. The maximum score is 35. Higher scores mean a worse outcome.	12 months after surgery
Incidence of urinary complications	Incidence of urinary complications	3 months after surgery
Health-related quality of life (15D) score	Health-related quality of life(15D) score compared to 15D score before surgery. The minimum score is 0. The maximum score is 1. Higher scores mean a better outcome.	3 months after surgery
Incidence of urinary complications	Incidence of urinary complications	12 months after surgery
Health-related quality of life (15D) score	Health-related quality of life(15D) score compared to 15D score before surgery. The minimum score is 0. The maximum score is 1. Higher scores mean a better outcome.	12 months after surgery

Collaborators and Investigators

• Sponsor: Central Finland Hospital District
• Collaborators: University of Eastern Finland
• Investigators: Principal Investigator: Juha Paloneva, professor, Chief medical director; Study Chair: Heikki Seikkula, PhD, Investigator; Study Chair: Juho Sippola, MD, Investigator; Study Chair: Konsta Pamilo, PhD, Investigator; Study Chair: Jonne Åkerla, MD, Investigator; Study Chair: Aleksi Reito, PhD, Investigator; Study Chair: Pirkko Kinnunen, Investigator

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Retention
• Other Study ID Numbers: 1U/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No