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NCT Number: NCT04707001

Urinary Retention After Arthroplasty

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Finland Hospital Nova

Jyväskylä, 40620, Finland

Location status: Recruiting

Location contact

Juha Paloneva, MD, PhD

CONTACT

+358 14 2693119

Juho Sippola, MD

CONTACT

+358 14 2691908

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catheterization based on ultrasound

Other

Bladder volume ultrasound

Catheterization based on evaluation of symptoms

Other

Ask for symptoms: Need to urinate, lower abdominal pain

Primary outcomes

  1. International Prostate Symptom Score (IPSS)

    Time frame: 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 outcomes

  1. International Prostate Symptom Score (IPSS)

    Time frame: 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.

  2. Incidence of urinary complications

    Time frame: 3 months after surgery

    Incidence of urinary complications

  3. Health-related quality of life (15D) score

    Time frame: 3 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.

  4. Incidence of urinary complications

    Time frame: 12 months after surgery

    Incidence of urinary complications

  5. Health-related quality of life (15D) score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Juha Paloneva, professor

CONTACT

[email protected]

014 269 1680

Juho Sippola, MD

CONTACT

[email protected]

014 269 1908

Sponsors and collaborators

Lead sponsor

Central Finland Hospital District

Other

Collaborators

  • University of Eastern Finland

Registry information

Official study title

Urinary Retention After Arthroplasty - UREA Trial

Acronym: UREA

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Jan 13, 2021
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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