Clinical trial NCT04707001: Urinary Retention After Arthroplasty
Official title: Urinary Retention After Arthroplasty - UREA Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Retention Postoperative
Arthroplasty Complications
Lead sponsor: Central Finland Hospital District
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2021-01-13
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open label
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: 3 months after surgery
Secondary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: 12 months after surgery
measure: Incidence of urinary complications
timeFrame: 3 months after surgery
measure: Health-related quality of life (15D) score
timeFrame: 3 months after surgery
measure: Incidence of urinary complications
timeFrame: 12 months after surgery
measure: Health-related quality of life (15D) score
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Hospital Nova
Study officials:
affiliation: Chief medical director
name: Juha Paloneva, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigator
name: Heikki Seikkula, PhD
role: STUDY_CHAIR
affiliation: Investigator
name: Juho Sippola, MD
role: STUDY_CHAIR
affiliation: Investigator
name: Konsta Pamilo, PhD
role: STUDY_CHAIR
affiliation: Investigator
name: Jonne Åkerla, MD
role: STUDY_CHAIR
affiliation: Investigator
name: Aleksi Reito, PhD
role: STUDY_CHAIR
affiliation: Investigator
name: Pirkko Kinnunen
role: STUDY_CHAIR
References: