NCT04707001

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
May 2021Jul 2026

First Submitted

Initial submission to the registry

January 11, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

3.6 years

First QC Date

January 11, 2021

Last Update Submit

February 12, 2024

Conditions

Urinary Retention PostoperativeArthroplasty Complications

Outcome Measures

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.

    3 months after surgery

Secondary Outcomes (5)

  • International Prostate Symptom Score (IPSS)

    12 months after surgery

  • Incidence of urinary complications

    3 months after surgery

  • Health-related quality of life (15D) score

    3 months after surgery

  • Incidence of urinary complications

    12 months after surgery

  • Health-related quality of life (15D) score

    12 months after surgery

Study Arms (2)

Ultrasound monitoring group

ACTIVE COMPARATOR

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.

Other: Catheterization based on ultrasound

Symptoms alone group

ACTIVE COMPARATOR

Urination is monitored by asking at regular intervals about the onset of spontaneous urination and the patient is catheterized only on a symptomatic basis.

Other: Catheterization based on evaluation of symptoms

Interventions

Catheterization based on ultrasoundOTHER

Bladder volume ultrasound

Ultrasound monitoring group
Catheterization based on evaluation of symptomsOTHER

Ask for symptoms: Need to urinate, lower abdominal pain

Symptoms alone group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsin 1:1 ratio. Participant eligibility is based on self-representation of gender identity.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective total knee arthroplasty

You may not qualify if:

  • previous surgery for urologic cancer
  • fracture as indication for surgery
  • lack of co-operation
  • untreated urinary retention
  • nephrostoma
  • general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Finland Hospital Nova

Jyväskylä, 40620, Finland

RECRUITING

Study Officials

  • Juha Paloneva, professor

    Chief medical director

    PRINCIPAL INVESTIGATOR

  • Heikki Seikkula, PhD

    Investigator

    STUDY CHAIR

  • Juho Sippola, MD

    Investigator

    STUDY CHAIR

  • Konsta Pamilo, PhD

    Investigator

    STUDY CHAIR

  • Jonne Åkerla, MD

    Investigator

    STUDY CHAIR

  • Aleksi Reito, PhD

    Investigator

    STUDY CHAIR

  • Pirkko Kinnunen

    Investigator

    STUDY CHAIR

Central Study Contacts

Juha Paloneva, professor

CONTACT

014 269 1680juha.paloneva@ksshp.fi

Juho Sippola, MD

CONTACT

014 269 1908juho.sippola@ksshp.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: open label
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 13, 2021

Study Start

May 1, 2021

Primary Completion

December 1, 2024

Study Completion (Estimated)

July 1, 2026

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)