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Trials / Recruiting

RecruitingNCT04707001

Urinary Retention After Arthroplasty

Urinary Retention After Arthroplasty - UREA Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
170 (estimated)
Sponsor
Central Finland Hospital District · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERCatheterization based on ultrasoundBladder volume ultrasound
OTHERCatheterization based on evaluation of symptomsAsk for symptoms: Need to urinate, lower abdominal pain

Timeline

Start date
2021-05-01
Primary completion
2024-12-01
Completion
2026-07-01
First posted
2021-01-13
Last updated
2024-02-13

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT04707001. Inclusion in this directory is not an endorsement.