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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Urinary Retention (POUR)

Intervention / Treatment
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* Procedure: increased interventional threshold for urinary bladder catheterization (800 ml)
* Procedure: Current used interventional threshold for urinary bladder catheterization (500 ml)
* Device: Intermittent bladder catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 125 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 500 ml.<br>A bladder volume of 500 ml. or more, and incapability of voluntary micturition, is used as interventional threshold for urinary bladder catheterization. | Procedure: Current used interventional threshold for urinary bladder catheterization (500 ml)<br> <br> Device: Intermittent bladder catheter<br> <br> |
| Experimental: 800 ml<br>A bladder volume of 800 ml. or more, and incapability of voluntary micturition, is used as interventional threshold for urinary bladder catheterization. | Procedure: increased interventional threshold for urinary bladder catheterization (800 ml)<br> <br> Device: Intermittent bladder catheter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients receiving postoperative urinary bladder catheterization |  | Patients will be followed from end of surgery to their first voluntary micturition, expectably within a mean period of twelve hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of urinary tract infections |  | within the first 30 days after surgery | 
| Number of voiding difficulties acquired postoperatively |  | within the first 30 days postoperatively | 
| Number of readmissions due to urological issues (including urosepsis) |  | Within the first 30 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative urinary retention, Fast-track total hip (THA) and knee arthroplasty (TKA), Urinary bladder volume