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OpenTrials
Completed

NCT Number: NCT02133768

Routine Bladder Catheterisation Through Fast-track Hip and Knee Replacement - What Are the Consequences?

To describe the need for re-catheterization and incidence of urological complications of routine use of perioperative fixed urinary catheter (KAD) for up to 24 hours of fast-track THA and TKA

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Key information

Conditions

Postoperative Urinary Retention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopedic

Holstebro, Central Jutland, 7500, Denmark

About this study

Postoperative urinary retention (POUR) is a well known complication of fast-track total hip (THA) and knee arthroplasty (TKA), and even though medical options have been attempted, bladder catheterisation remains the only well-documented capacity to prevent and / or treat POUR.

It was previously standard to use fixed urinary catheter (KAD), the first 24-48 hours postoperatively to prevent POUR by THA and TKA, while more recent studies now recommend intermittent urinary catheterization in the postoperative period.

However, there are no detailed studies with adequate follow-up, describing the consequences of using either one or the other treatment regimen of POUR by fast-track THA and TKA.

Purpose:

To describe the need for re-catheterization and incidence of urological complications of routine use of perioperative fixed urinary catheter (KAD,catheter a demure) for up to 24 hours of fast-track THA and TKA

End Points:

  • The number of patients in need of re-catheterization due POUR
  • The number of patients in which the removal of KAD was not carried out within 24 hours.
  • The number of urinary tract infections from surgery to postoperative day (POD) 30
  • The number of patients with new-onset urinary discomfort at POD 30 (Increase in IPSS score).
  • The number of urological-related readmissions (including urosepsis) within POD 30

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients must meet all the following criteria to be eligible to enroll in the study:
  • Age >50 years.
  • Patients scheduled for primary THA or TKA.
  • Patients who have given verbal consent to participate in the study.

Exclusion criteria

  • Patients who meet one or more of the following criteria may not be included in the study:
  • Patients who can not cooperate with the study.
  • Patients who do not understand or speak Danish.
  • Patients who are permanent catheter carriers or use disposable bladder catheterisation.
  • Patients on hemodialysis.
  • Urine Derivative patients.
  • Pregnancy or childbirth within 6 months.

Treatment and study plan

Primary outcomes

  1. Number of patients needing re-catheterization

    Time frame: From removal of urinary catheter at first postoperative day and untill discharge from hospital

    The need for re-catheterization will be asses on a daily basis until discharge from hospital (median 3 days from surgery)

Secondary outcomes

  1. Number of patients who did not get their urinary catheter removed on the first postoperative day

    Time frame: within the first 24 hours after surgery

  2. Number of urinary tract infections

    Time frame: within the first 30 days after surgery

    Assessed on a daily basis during admision and detailed telephone interview on day 30 after surgery

  3. Number of patients developing postoperative micturition difficulties

    Time frame: From day 1 to day 30 after surgery

    All patients completes a questionary preoperatively (the international prostate symptom score) and the same questionary again on day 30 after surgery.

  4. Number of re-admission due to urological problems, including urosepsis

    Time frame: within the first 30 days after surgery

    assessed by telephone interview on day 30 after surgery

Sponsors and collaborators

Lead sponsor

Lundbeck Foundation

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 8, 2014
Registry last updated
Mar 7, 2017

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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