Clinical Trials Directory

Trials / Completed

CompletedNCT02126813

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
800 (actual)
Sponsor
Rigshospitalet, Denmark · Academic / Other
Sex
All
Age
18 Years – 125 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREincreased interventional threshold for urinary bladder catheterization (800 ml)
PROCEDURECurrent used interventional threshold for urinary bladder catheterization (500 ml)
DEVICEIntermittent bladder catheter

Timeline

Start date
2014-05-01
Primary completion
2015-05-01
Completion
2015-05-01
First posted
2014-04-30
Last updated
2015-10-28

Locations

3 sites across 1 country: Denmark

Source: ClinicalTrials.gov record NCT02126813. Inclusion in this directory is not an endorsement.