Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-02-17 @ 10:50 PM
Study NCT ID:
NCT02133768
Status:
COMPLETED
Last Update Posted:
2017-03-07
First Post:
2014-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Routine Bladder Catheterisation Through Fast-track Hip and Knee Replacement - What Are the Consequences?
Sponsor:
Lundbeck Foundation
Organization:
Study Overview
Official Title:
Routine Bladder Catheterisation Through Fast-track Hip and Knee Replacement - What Are the Consequences?
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To describe the need for re-catheterization and incidence of urological complications of routine use of perioperative fixed urinary catheter (KAD) for up to 24 hours of fast-track THA and TKA
Detailed Description:
Postoperative urinary retention (POUR) is a well known complication of fast-track total hip (THA) and knee arthroplasty (TKA), and even though medical options have been attempted, bladder catheterisation remains the only well-documented capacity to prevent and / or treat POUR.
It was previously standard to use fixed urinary catheter (KAD), the first 24-48 hours postoperatively to prevent POUR by THA and TKA, while more recent studies now recommend intermittent urinary catheterization in the postoperative period.
However, there are no detailed studies with adequate follow-up, describing the consequences of using either one or the other treatment regimen of POUR by fast-track THA and TKA.
Purpose:
To describe the need for re-catheterization and incidence of urological complications of routine use of perioperative fixed urinary catheter (KAD,catheter a demure) for up to 24 hours of fast-track THA and TKA
End Points:
1. The number of patients in need of re-catheterization due POUR
2. The number of patients in which the removal of KAD was not carried out within 24 hours.
3. The number of urinary tract infections from surgery to postoperative day (POD) 30
4. The number of patients with new-onset urinary discomfort at POD 30 (Increase in IPSS score).
5. The number of urological-related readmissions (including urosepsis) within POD 30
It was previously standard to use fixed urinary catheter (KAD), the first 24-48 hours postoperatively to prevent POUR by THA and TKA, while more recent studies now recommend intermittent urinary catheterization in the postoperative period.
However, there are no detailed studies with adequate follow-up, describing the consequences of using either one or the other treatment regimen of POUR by fast-track THA and TKA.
Purpose:
To describe the need for re-catheterization and incidence of urological complications of routine use of perioperative fixed urinary catheter (KAD,catheter a demure) for up to 24 hours of fast-track THA and TKA
End Points:
1. The number of patients in need of re-catheterization due POUR
2. The number of patients in which the removal of KAD was not carried out within 24 hours.
3. The number of urinary tract infections from surgery to postoperative day (POD) 30
4. The number of patients with new-onset urinary discomfort at POD 30 (Increase in IPSS score).
5. The number of urological-related readmissions (including urosepsis) within POD 30
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Lundbeck Foundation | OTHER | Lundbeck Foundation | View |