Urinary Retention After Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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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

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Urinary Retention Postoperative Arthroplasty Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

open label

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ultrasound monitoring group

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.

Group Type ACTIVE_COMPARATOR

Catheterization based on ultrasound

Intervention Type OTHER

Bladder volume ultrasound

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.

Group Type ACTIVE_COMPARATOR

Catheterization based on evaluation of symptoms

Intervention Type OTHER

Ask for symptoms: Need to urinate, lower abdominal pain

Interventions

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Catheterization based on ultrasound

Bladder volume ultrasound

Intervention Type OTHER

Catheterization based on evaluation of symptoms

Ask for symptoms: Need to urinate, lower abdominal pain

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes