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Completed

NCT Number: NCT02126813

When to Perform Bladder Catheterization in Fast-track Hip and Knee Arthroplasty

Approximately 40 % of all patients undergoing fast-track total hip or knee arthroplasty needs intermittent bladder catheterization after surgery, as they are transient incapable of voluntary bladder emptying (postoperative urinary retention - POUR). The currently used interventional threshold for urinary bladder catheterization are a bladder volume of approximately 500 ml., but no evidence exists for this threshold. At the same time, the current knowledge suggest, that a bladder volume up to 1000 ml. for 2-4 hours are safe in humans, and as the use of urinary bladder catheterization are increasing the risk of complications, the investigators are hypothesizing that increasing the interventional threshold for urinary bladder catheterization after fast-track total hip or knee arthroplasty, will reduce the number of patients needing urinary bladder catheterization, without increasing the incidence of urological complications - including urinary tract infections.

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Key information

Conditions

Postoperative Urinary Retention (POUR)

Age range

18 year–125 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Farsoe, Farsø, Denmark

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • planned for elective total hip or knee arthroplasty
  • given written informed consent for participation

Exclusion criteria

  • can't co-operate to participation
  • can't speak or understand danish
  • preoperative use of urinary bladder catheterization
  • using haemodialysis
  • previous cystectomy
  • need for permanent urinary bladder catheter during surgery (decided by anaesthesiologist and/or surgeon)
  • Pregnant or given birth within the last 6 months

Treatment and study plan

increased interventional threshold for urinary bladder catheterization (800 ml)

Procedure

Current used interventional threshold for urinary bladder catheterization (500 ml)

Procedure

Intermittent bladder catheter

Device

Primary outcomes

  1. Number of patients receiving postoperative urinary bladder catheterization

    Time frame: Patients will be followed from end of surgery to their first voluntary micturition, expectably within a mean period of twelve hours

Secondary outcomes

  1. Incidence of urinary tract infections

    Time frame: within the first 30 days after surgery

  2. Number of voiding difficulties acquired postoperatively

    Time frame: within the first 30 days postoperatively

  3. Number of readmissions due to urological issues (including urosepsis)

    Time frame: Within the first 30 days postoperatively

Other outcomes

  1. Time from last preoperative micturition to end of surgery.

    Time frame: Patients will be follwed from their last preoperative micturition to end of surgery. Expectably within a mean period of two hours.

  2. Time from last preoperative micturitions to first postoperative bladder catheterization (if relevant).

    Time frame: Patients will be follwed from their last preoperative micturition to their first postoperative bladder catheterization (if relevant). Expectably within a mean period of six to eight hours.

  3. Time from last preoperative micturition to first postoperative, voluntary micturition.

    Time frame: Patients will be follwed from their last preoperative micturition to their first postoperative, voluntary micturition. Expectably within a mean period of fourteen hours.

  4. Time from end of surgery to first postoperative bladder catheterization (if relevant).

    Time frame: Patients will be follwed from end of surgery to their first postoperative bladder catheterization (if relevant). Expectably within a mean period of four to six hours.

  5. Time from end of surgery to first postoperative, voluntary micturition.

    Time frame: Patient will be followed from end of surgery to their first postoperative, voluntary micturition. Expectably within a mean period of twelve hours.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Lundbeck Foundation

Registry information

Official study title

Urinary Bladder Catheterization in Fast-track Hip and Knee Arthroplasty - What is the Optimal Bladder Volume? A Randomized, Controlled Study

Acronym: POUR-RCT

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 30, 2014
Registry last updated
Oct 28, 2015

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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