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

NCT ID: NCT02126813

Last Updated: 2015-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-05-31

Brief Summary

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.

Conditions

Postoperative Urinary Retention (POUR)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

500 ml.

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

Intermittent bladder catheter

Intervention Type: DEVICE

800 ml

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

Group Type: EXPERIMENTAL

increased interventional threshold for urinary bladder catheterization (800 ml)

Intervention Type: PROCEDURE

Intermittent bladder catheter

Intervention Type: DEVICE

Interventions

increased interventional threshold for urinary bladder catheterization (800 ml)

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Intermittent bladder catheter

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 125 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lundbeck Foundation

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Lars Bjerregaard

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars Bjerregaard, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Copenhagen university, Denmark

Locations

Aalborg University Hospital, Farsoe

Farsø, , Denmark

Department of Orthopaedics, Gentofte University Hospital

Hellerup, , Denmark

Department of Orthopaedics, Vejle Hospital

Vejle, , Denmark

Countries

Denmark

Other Identifiers

POUR-RCT

Identifier Type: -

Identifier Source: org_study_id