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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Urinary Retention (POUR)
• Intervention / Treatment: Procedure: Current used interventional threshold for urinary bladder catheterization (500 ml); Device: Intermittent bladder catheter; Procedure: increased interventional threshold for urinary bladder catheterization (800 ml)

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Farsoe, Denmark, 9640
    • Aalborg University Hospital, Farsoe
  • Hellerup, Denmark, 2900
    • Department of Orthopaedics, Gentofte University Hospital
  • Vejle, Denmark, 7100
    • Department of Orthopaedics, Vejle Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 125 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
Time from last preoperative micturition to end of surgery.	Patients will be follwed from their last preoperative micturition to end of surgery. Expectably within a mean period of two hours.
Time from last preoperative micturitions to first postoperative bladder catheterization (if relevant).	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.
Time from last preoperative micturition to first postoperative, voluntary micturition.	Patients will be follwed from their last preoperative micturition to their first postoperative, voluntary micturition. Expectably within a mean period of fourteen hours.
Time from end of surgery to first postoperative bladder catheterization (if relevant).	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.
Time from end of surgery to first postoperative, voluntary micturition.	Patient will be followed from end of surgery to their first postoperative, voluntary micturition. Expectably within a mean period of twelve hours.

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Lundbeck Foundation
• Investigators: Principal Investigator: Lars Bjerregaard, MD, Rigshospitalet, Copenhagen University, Denmark

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: April 24, 2014
• First Submitted That Met QC Criteria: April 29, 2014
• First Posted (Estimate): April 30, 2014

Study Record Updates

• Last Update Posted (Estimate): October 28, 2015
• Last Update Submitted That Met QC Criteria: October 27, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Postoperative urinary retention; Fast-track total hip (THA) and knee arthroplasty (TKA); Urinary bladder volume
• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Urinary Retention
• Other Study ID Numbers: POUR-RCT