Urinary Retention PostoperativeUREANCT04707001
Urinary Retention After Arthroplasty
A study testing Catheterization based on ultrasound and Catheterization based on evaluation of symptoms in people with Urinary Retention Postoperative and Arthroplasty Complications, run by Central Finland Hospital District at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention Postoperative, Arthroplasty Complications
- What is being tested?
- Catheterization based on ultrasound and Catheterization based on evaluation of symptoms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteFinland
- Study dates
- 1 May 2021to Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elective total knee arthroplasty
Who cannot join
- previous surgery for urologic cancer
- fracture as indication for surgery
- lack of co-operation
- untreated urinary retention
- nephrostoma
- general anesthesia
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Central Finland Hospital Nova
Jyväskylä, 40620
Juha Paloneva, MD, PhD, +358 14 2693119
Juho Sippola, MD, +358 14 2691908
About this study
Official title: Urinary Retention After Arthroplasty - UREA Trial
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.
Read the 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.
- Being tested
- Catheterization based on ultrasound, Catheterization based on evaluation of symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheterization based on ultrasoundOther
Bladder volume ultrasound
Catheterization based on evaluation of symptomsOther
Ask for symptoms: Need to urinate, lower abdominal pain
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound monitoring group | Active comparator | 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. Receives: Other: Catheterization based on ultrasound |
| Symptoms alone group | Active comparator | Urination is monitored by asking at regular intervals about the onset of spontaneous urination and the patient is catheterized only on a symptomatic basis. Receives: Other: Catheterization based on evaluation of symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after surgery
Secondary outcomes (5)
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.
Measured: 12 months after surgery
Incidence of urinary complications
Incidence of urinary complications
Measured: 3 months after surgery
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.
Measured: 3 months after surgery
Incidence of urinary complications
Incidence of urinary complications
Measured: 12 months after surgery
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.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 May 2021
- Primary completionDec 2024 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Retention PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open label
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Finland Hospital District
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
- Responsible party
- Sponsor
- Investigators
- Juha Paloneva, professor, Principal investigator, Chief medical directorHeikki Seikkula, PhD, Study chair, InvestigatorJuho Sippola, MD, Study chair, InvestigatorKonsta Pamilo, PhD, Study chair, InvestigatorJonne Åkerla, MD, Study chair, InvestigatorAleksi Reito, PhD, Study chair, InvestigatorPirkko Kinnunen, Study chair, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707001
- Sponsor's protocol ID
- 1U/2020
- Acronym
- UREA
- Status last verified
- Feb 2024
- First submitted
- 11 Jan 2021
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Retention After Arthroplasty - UREA Trial
- ClinicalTrials.gov ID
- NCT04707001
- Acronym / sponsor ID
- UREA / 1U/2020
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Central Finland Hospital DistrictUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- 1 May 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label
| Arm | Type | Receives |
|---|---|---|
| Ultrasound monitoring group | Active comparator | Other: Catheterization based on ultrasoundIn 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. |
| Symptoms alone group | Active comparator | Other: Catheterization based on evaluation of symptomsUrination is monitored by asking at regular intervals about the onset of spontaneous urination and the patient is catheterized only on a symptomatic basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective total knee arthroplasty
Key exclusion criteria (6 listed)
- previous surgery for urologic cancer
- fracture as indication for surgery
- lack of co-operation
- untreated urinary retention
- nephrostoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheterization based on ultrasoundBladder volume ultrasound | Other | Ultrasound monitoring group |
| Catheterization based on evaluation of symptomsAsk for symptoms: Need to urinate, lower abdominal pain | Other | Symptoms alone group |
Primary outcome
International Prostate Symptom Score (IPSS)
Time frame: 3 months after surgery
IPSS questionnaire compared to IPSS before surgery. The minimum score is 0. The maximum score is 35. Higher scores mean a worse outcome.
5 secondary outcomes
International Prostate Symptom Score (IPSS)
Time frame: 12 months after surgery
Incidence of urinary complications
Time frame: 3 months after surgery
Health-related quality of life (15D) score
Time frame: 3 months after surgery
Incidence of urinary complications
Time frame: 12 months after surgery
Health-related quality of life (15D) score
Time frame: 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juha Paloneva, professor principal investigator
Chief medical director
Heikki Seikkula, PhD study chair
Investigator
Juho Sippola, MD study chair
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheterization based on ultrasound and Catheterization based on evaluation of symptoms in people with Urinary Retention Postoperative and Arthroplasty Complications, run by Central Finland Hospital District at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juha Paloneva, professor (014 269 1680, juha.paloneva@ksshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score (IPSS) (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.