Urinary Retention After Arthroplasty (UREA)
Primary Purpose
Urinary Retention Postoperative, Arthroplasty Complications
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Catheterization based on ultrasound
Catheterization based on evaluation of symptoms
Sponsored by
About this trial
This is an interventional diagnostic trial for Urinary Retention Postoperative
Eligibility Criteria
Inclusion Criteria:
- elective total knee arthroplasty
Exclusion Criteria:
- previous surgery for urologic cancer
- fracture as indication for surgery
- lack of co-operation
- untreated urinary retention
- nephrostoma
- general anesthesia
Sites / Locations
- Central Finland Hospital NovaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ultrasound monitoring group
Symptoms alone group
Arm Description
In the ultrasound group, urinary retention is monitored, according to current practice, with an ultrasound scanner and the patient is catheterized if necessary, if residual urine exceeds 800 ml, or if the patient is symptomatic.
Urination is monitored by asking at regular intervals about the onset of spontaneous urination and the patient is catheterized only on a symptomatic basis.
Outcomes
Primary Outcome Measures
International Prostate Symptom Score (IPSS)
IPSS questionnaire compared to IPSS before surgery. The minimum score is 0. The maximum score is 35. Higher scores mean a worse outcome.
Secondary Outcome Measures
International Prostate Symptom Score (IPSS)
IPSS questionnaire compared to IPSS before surgery. The minimum score is 0. The maximum score is 35. Higher scores mean a worse outcome.
Incidence of urinary complications
Incidence of urinary complications
Health-related quality of life (15D) score
Health-related quality of life(15D) score compared to 15D score before surgery. The minimum score is 0. The maximum score is 1. Higher scores mean a better outcome.
Incidence of urinary complications
Incidence of urinary complications
Health-related quality of life (15D) score
Health-related quality of life(15D) score compared to 15D score before surgery. The minimum score is 0. The maximum score is 1. Higher scores mean a better outcome.
Full Information
NCT ID
NCT04707001
First Posted
January 11, 2021
Last Updated
March 21, 2023
Sponsor
Central Finland Hospital District
Collaborators
University of Eastern Finland
1. Study Identification
Unique Protocol Identification Number
NCT04707001
Brief Title
Urinary Retention After Arthroplasty
Acronym
UREA
Official Title
Urinary Retention After Arthroplasty - UREA Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Finland Hospital District
Collaborators
University of Eastern Finland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Arthroplasty increases the risk of postoperative urinary retention. Treatment of postoperative urinary retention is indwelling or intermittent catheterization. The need for catheterization is most commonly determined with an ultrasound scanner. Catheterization increases the risk of urinary tract infection, which may further lead to haematogenic infection of the artificial joint. There is no evidence of an optimal way to monitor the onset of spontaneous urination.
The aim of the study is to determine whether monitoring the onset of spontaneous urination after fast track knee arthroplasty is safe based on symptoms alone without ultrasound monitoring.
Detailed Description
Adult patients undergoing knee arthroplasty will be recruited to this study. Participants will be randomized to the ultrasound monitoring group or the symptoms alone group. In the symptoms alone group, urination is monitored by asking at regular intervals about the onset of spontaneous urination and the patient is catheterized only on a symptomatic basis or if spontaneous voiding has not started 10 hours after the spinal anesthesia. Symptoms that indicate catheterization are lower abdominal pain or need to void. In the ultrasound group, urinary retention is monitored according to current practice with an ultrasound scanner and the patient is catheterized if residual urine exceeds 800 ml or if the patient is symptomatic.
The primary outcome variable is the change in IPSS score from the baseline to 3 months after the procedure. The baseline score is evaluated preoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention Postoperative, Arthroplasty Complications
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
open label
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound monitoring group
Arm Type
Active Comparator
Arm Description
In the ultrasound group, urinary retention is monitored, according to current practice, with an ultrasound scanner and the patient is catheterized if necessary, if residual urine exceeds 800 ml, or if the patient is symptomatic.
Arm Title
Symptoms alone group
Arm Type
Active Comparator
Arm Description
Urination is monitored by asking at regular intervals about the onset of spontaneous urination and the patient is catheterized only on a symptomatic basis.
Intervention Type
Other
Intervention Name(s)
Catheterization based on ultrasound
Intervention Description
Bladder volume ultrasound
Intervention Type
Other
Intervention Name(s)
Catheterization based on evaluation of symptoms
Intervention Description
Ask for symptoms: Need to urinate, lower abdominal pain
Primary Outcome Measure Information:
Title
International Prostate Symptom Score (IPSS)
Description
IPSS questionnaire compared to IPSS before surgery. The minimum score is 0. The maximum score is 35. Higher scores mean a worse outcome.
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
International Prostate Symptom Score (IPSS)
Description
IPSS questionnaire compared to IPSS before surgery. The minimum score is 0. The maximum score is 35. Higher scores mean a worse outcome.
Time Frame
12 months after surgery
Title
Incidence of urinary complications
Description
Incidence of urinary complications
Time Frame
3 months after surgery
Title
Health-related quality of life (15D) score
Description
Health-related quality of life(15D) score compared to 15D score before surgery. The minimum score is 0. The maximum score is 1. Higher scores mean a better outcome.
Time Frame
3 months after surgery
Title
Incidence of urinary complications
Description
Incidence of urinary complications
Time Frame
12 months after surgery
Title
Health-related quality of life (15D) score
Description
Health-related quality of life(15D) score compared to 15D score before surgery. The minimum score is 0. The maximum score is 1. Higher scores mean a better outcome.
Time Frame
12 months after surgery
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
in 1:1 ratio. Participant eligibility is based on self-representation of gender identity.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
elective total knee arthroplasty
Exclusion Criteria:
previous surgery for urologic cancer
fracture as indication for surgery
lack of co-operation
untreated urinary retention
nephrostoma
general anesthesia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juha Paloneva, professor
Phone
014 269 1680
Email
juha.paloneva@ksshp.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Juho Sippola, MD
Phone
014 269 1908
Email
juho.sippola@ksshp.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juha Paloneva, professor
Organizational Affiliation
Chief medical director
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heikki Seikkula, PhD
Organizational Affiliation
Investigator
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Juho Sippola, MD
Organizational Affiliation
Investigator
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Konsta Pamilo, PhD
Organizational Affiliation
Investigator
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jonne Åkerla, MD
Organizational Affiliation
Investigator
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Aleksi Reito, PhD
Organizational Affiliation
Investigator
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pirkko Kinnunen
Organizational Affiliation
Investigator
Official's Role
Study Chair
Facility Information:
Facility Name
Central Finland Hospital Nova
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juha Paloneva, MD, PhD
Phone
+358 14 2693119
First Name & Middle Initial & Last Name & Degree
Juho Sippola, MD
Phone
+358 14 2691908
12. IPD Sharing Statement
Plan to Share IPD
No
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Urinary Retention After Arthroplasty
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