Urinary Retention After Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Finland Hospital District
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
elective total knee arthroplasty
Disqualifiers
previous surgery for urologic cancer
fracture as indication for surgery
lack of co-operation
untreated urinary retention
Trial design
Design model
Parallel
Treatments tested in this trial
Catheterization based on ultrasound
Other interventionBladder volume ultrasound
Catheterization based on evaluation of symptoms
Other interventionAsk for symptoms: Need to urinate, lower abdominal pain
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Ultrasound monitoring groupActive comparator 1 intervention
Group B: Symptoms alone groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months after surgerySecondary outcomes
1
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.
Time frame
12 months after surgery2
Incidence of urinary complications
Incidence of urinary complications
Time frame
3 months after surgery3
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.
Time frame
3 months after surgery4
Incidence of urinary complications
Incidence of urinary complications
Time frame
12 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Central Finland Hospital District
Lead sponsor
University of Eastern Finland
Collaborator
Source ClinicalTrials.gov