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Urinary Retention After Arthroplasty

Urinary Retention After Arthroplasty - UREA Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04707001
Acronym
UREA
Enrollment
170
Registered
2021-01-13
Start date
2021-05-01
Completion date
2026-07-31
Last updated
2024-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty Complications, Urinary Retention Postoperative

Brief 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.

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.

Interventions

OTHERCatheterization based on ultrasound

Bladder volume ultrasound

OTHERCatheterization based on evaluation of symptoms

Ask for symptoms: Need to urinate, lower abdominal pain

Sponsors

University of Eastern Finland
CollaboratorOTHER
Central Finland Hospital District
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

open label

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
International Prostate Symptom Score (IPSS)3 months after surgeryIPSS questionnaire compared to IPSS before surgery. The minimum score is 0. The maximum score is 35. Higher scores mean a worse outcome.

Secondary

MeasureTime frameDescription
International Prostate Symptom Score (IPSS)12 months after surgeryIPSS questionnaire compared to IPSS before surgery. The minimum score is 0. The maximum score is 35. Higher scores mean a worse outcome.
Incidence of urinary complications3 months after surgeryIncidence of urinary complications
Health-related quality of life (15D) score3 months after surgeryHealth-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.

Countries

Finland

Contacts

Primary ContactJuha Paloneva, professor
juha.paloneva@ksshp.fi014 269 1680
Backup ContactJuho Sippola, MD
juho.sippola@ksshp.fi014 269 1908

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026