When to Perform Bladder Catheterization in Fast-track Hip and Knee Arthroplasty (POUR-RCT)

Rigshospitalet

Status: Completed

Conditions: Postoperative Urinary Retention (POUR)

Treatments: Device: Intermittent bladder catheter; Procedure: Current used interventional threshold for urinary bladder catheterization (500 ml); Procedure: increased interventional threshold for urinary bladder catheterization (800 ml)

Study type: Interventional

Funder types: Other

Identifiers

NCT02126813

POUR-RCT

Details and patient eligibility

About

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.

Enrollment: 800 patients

Sex: All

Ages: 18 to 125 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

500 ml.

Active Comparator group

Description:

A bladder volume of 500 ml. or more, and incapability of voluntary micturition, is used as interventional threshold for urinary bladder catheterization.

Treatment:

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

Device: Intermittent bladder catheter

800 ml

Experimental group

Description:

A bladder volume of 800 ml. or more, and incapability of voluntary micturition, is used as interventional threshold for urinary bladder catheterization.

Treatment:

Procedure: increased interventional threshold for urinary bladder catheterization (800 ml)

Device: Intermittent bladder catheter