Urinary Retention After Arthroplasty

Not Applicable

Recruiting

• Conditions: Arthroplasty Complications; Urinary Retention Postoperative
• Interventions: Other: Catheterization based on evaluation of symptoms; Other: Catheterization based on ultrasound

• Registration Number: NCT04707001
• Lead Sponsor: Central Finland Hospital District

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.

Study Timeline

• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-13
• Study Start: 2021-05-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13
• Primary Completion: 2024-12
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Symptoms alone group	Catheterization based on evaluation of symptoms	Urination is monitored by asking at regular intervals about the onset of spontaneous urination and the patient is catheterized only on a symptomatic basis.
Ultrasound monitoring group	Catheterization based on ultrasound	In the ultrasound group, urinary retention is monitored, according to current practice, with an ultrasound scanner and the patient is catheterized if necessary, if residual urine exceeds 800 ml, or if the patient is symptomatic.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life (15D) score	12 months after surgery	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.
International Prostate Symptom Score (IPSS)	12 months after surgery	IPSS 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 complications	12 months after surgery	Incidence of urinary complications

Trial Locations

Locations (1)

Central Finland Hospital Nova; 🇫🇮 Jyväskylä, Finland