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

Primary Purpose

Postoperative Urinary Retention (POUR)

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
increased interventional threshold for urinary bladder catheterization (800 ml)
Current used interventional threshold for urinary bladder catheterization (500 ml)
Intermittent bladder catheter
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Urinary Retention (POUR) focused on measuring Postoperative urinary retention, Fast-track total hip (THA) and knee arthroplasty (TKA), Urinary bladder volume

Eligibility Criteria

18 Years - 125 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aalborg University Hospital, Farsoe
  • Department of Orthopaedics, Gentofte University Hospital
  • Department of Orthopaedics, Vejle Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

500 ml.

800 ml

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of patients receiving postoperative urinary bladder catheterization

Secondary Outcome Measures

Incidence of urinary tract infections
Number of voiding difficulties acquired postoperatively
Number of readmissions due to urological issues (including urosepsis)

Full Information

First Posted
April 24, 2014
Last Updated
October 27, 2015
Sponsor
Rigshospitalet, Denmark
Collaborators
Lundbeck Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02126813
Brief Title
When to Perform Bladder Catheterization in Fast-track Hip and Knee Arthroplasty
Acronym
POUR-RCT
Official Title
Urinary Bladder Catheterization in Fast-track Hip and Knee Arthroplasty - What is the Optimal Bladder Volume? A Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Lundbeck Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Urinary Retention (POUR)
Keywords
Postoperative urinary retention, Fast-track total hip (THA) and knee arthroplasty (TKA), Urinary bladder volume

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
500 ml.
Arm Type
Active Comparator
Arm Description
A bladder volume of 500 ml. or more, and incapability of voluntary micturition, is used as interventional threshold for urinary bladder catheterization.
Arm Title
800 ml
Arm Type
Experimental
Arm Description
A bladder volume of 800 ml. or more, and incapability of voluntary micturition, is used as interventional threshold for urinary bladder catheterization.
Intervention Type
Procedure
Intervention Name(s)
increased interventional threshold for urinary bladder catheterization (800 ml)
Intervention Type
Procedure
Intervention Name(s)
Current used interventional threshold for urinary bladder catheterization (500 ml)
Intervention Type
Device
Intervention Name(s)
Intermittent bladder catheter
Primary Outcome Measure Information:
Title
Number of patients receiving postoperative urinary bladder catheterization
Time Frame
Patients will be followed from end of surgery to their first voluntary micturition, expectably within a mean period of twelve hours
Secondary Outcome Measure Information:
Title
Incidence of urinary tract infections
Time Frame
within the first 30 days after surgery
Title
Number of voiding difficulties acquired postoperatively
Time Frame
within the first 30 days postoperatively
Title
Number of readmissions due to urological issues (including urosepsis)
Time Frame
Within the first 30 days postoperatively
Other Pre-specified Outcome Measures:
Title
Time from last preoperative micturition to end of surgery.
Time Frame
Patients will be follwed from their last preoperative micturition to end of surgery. Expectably within a mean period of two hours.
Title
Time from last preoperative micturitions to first postoperative bladder catheterization (if relevant).
Time Frame
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.
Title
Time from last preoperative micturition to first postoperative, voluntary micturition.
Time Frame
Patients will be follwed from their last preoperative micturition to their first postoperative, voluntary micturition. Expectably within a mean period of fourteen hours.
Title
Time from end of surgery to first postoperative bladder catheterization (if relevant).
Time Frame
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.
Title
Time from end of surgery to first postoperative, voluntary micturition.
Time Frame
Patient will be followed from end of surgery to their first postoperative, voluntary micturition. Expectably within a mean period of twelve hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
125 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Bjerregaard, MD
Organizational Affiliation
Rigshospitalet, Copenhagen university, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital, Farsoe
City
Farsoe
ZIP/Postal Code
9640
Country
Denmark
Facility Name
Department of Orthopaedics, Gentofte University Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Department of Orthopaedics, Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark

12. IPD Sharing Statement

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

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