Urinary Retention After Arthroplasty

Arthroplasty Complications Clinical Trial

— UREA  

Official title:

Urinary Retention After Arthroplasty - UREA Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04707001
• Other study ID #: 1U/2020
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: July 2026

Study information

• Verified date: February 2024
• Source: Central Finland Hospital District
• Contact: Juha Paloneva, professor
• Phone: 014 269 1680
• Email: juha.paloneva[@]ksshp.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: July 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty Complications
• Urinary Retention
• Urinary Retention Postoperative

Intervention

Other:
• Catheterization based on ultrasound
Bladder volume ultrasound
• Catheterization based on evaluation of symptoms
Ask for symptoms: Need to urinate, lower abdominal pain

Locations

Country	Name	City	State
Finland	Central Finland Hospital Nova	Jyväskylä

Sponsors (2)

Lead Sponsor	Collaborator
Central Finland Hospital District	University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Incidence of urinary complications	Incidence of urinary complications	3 months after surgery
Secondary	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
Secondary	Incidence of urinary complications	Incidence of urinary complications	12 months after surgery
Secondary	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