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

NCT02126813 | Completed

• 1 other identifier: POUR-RCT
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 3

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)

Keywords

Postoperative urinary retention; Fast-track total hip (THA) and knee arthroplasty (TKA); Urinary bladder volume

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Outcomes (5)

• 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.

Study Arms (2)

500 ml.

ACTIVE COMPARATOR

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

800 ml

EXPERIMENTAL

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); Device: Intermittent bladder catheter

Interventions

increased interventional threshold for urinary bladder catheterization (800 ml) PROCEDURE

800 ml

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

500 ml.

Intermittent bladder catheter DEVICE

500 ml.; 800 ml

Eligibility Criteria

• Age: 18 Years - 125 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Lundbeck Foundation: collaborator

Study Sites (3)

Aalborg University Hospital, Farsoe

Farsø, 9640, Denmark

Location

Department of Orthopaedics, Gentofte University Hospital

Hellerup, 2900, Denmark

Location

Department of Orthopaedics, Vejle Hospital

Vejle, 7100, Denmark

Location

Study Officials

• Lars Bjerregaard, MD

  Rigshospitalet, Copenhagen university, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 30, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

DK (3)