Postoperative Urinary Retention (POUR)POUR-RCTNCT02126813
When to Perform Bladder Catheterization in Fast-track Hip and Knee Arthroplasty
A study testing increased interventional threshold for urinary bladder catheterization (800 ml), Current used interventional threshold for urinary bladder catheterization (500 ml) and Intermittent bladder catheter in people with Postoperative Urinary Retention (POUR), run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 125 years
- Conditions the study is for
- Postoperative Urinary Retention (POUR)
- What is being tested?
- increased interventional threshold for urinary bladder catheterization (800 ml), Current used interventional threshold for urinary bladder catheterization (500 ml) and Intermittent bladder catheter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 3 sitesDenmark
- Study dates
- May 2014to May 2015
- 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 to 125 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned for elective total hip or knee arthroplasty
- given written informed consent for participation
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aalborg University Hospital, Farsoe
Farsø, 9640
Department of Orthopaedics, Gentofte University Hospital
Hellerup, 2900
Department of Orthopaedics, Vejle Hospital
Vejle, 7100
About this study
Official title: Urinary Bladder Catheterization in Fast-track Hip and Knee Arthroplasty - What is the Optimal Bladder Volume? A Randomized, Controlled Study
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
- Postoperative Urinary Retention (POUR)
- Being tested
- increased interventional threshold for urinary bladder catheterization (800 ml), Current used interventional threshold for urinary bladder catheterization (500 ml), Intermittent bladder catheter
- Keywords
- Postoperative urinary retention, Fast-track total hip (THA) and knee arthroplasty (TKA), Urinary bladder volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
increased interventional threshold for urinary bladder catheterization (800 ml)Procedure or surgery
Current used interventional threshold for urinary bladder catheterization (500 ml)Procedure or surgery
Intermittent bladder catheterDevice
| Study group | Role | What they receive |
|---|---|---|
| 500 ml. | Active comparator | A bladder volume of 500 ml. or more, and incapability of voluntary micturition, is used as interventional threshold for urinary bladder catheterization. Receives: Procedure: Current used interventional threshold for urinary bladder catheterization (500 ml); Device: Intermittent bladder catheter |
| 800 ml | Experimental | A bladder volume of 800 ml. or more, and incapability of voluntary micturition, is used as interventional threshold for urinary bladder catheterization. Receives: Procedure: increased interventional threshold for urinary bladder catheterization (800 ml); Device: Intermittent bladder catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients receiving postoperative urinary bladder catheterization
Measured: Patients will be followed from end of surgery to their first voluntary micturition, expectably within a mean period of twelve hours
Secondary outcomes (3)
Incidence of urinary tract infections
Measured: within the first 30 days after surgery
Number of voiding difficulties acquired postoperatively
Measured: within the first 30 days postoperatively
Number of readmissions due to urological issues (including urosepsis)
Measured: Within the first 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Urinary Retention (POUR)Studies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Principal investigator, Lars Bjerregaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lars Bjerregaard, MD, Principal investigator, Rigshospitalet, Copenhagen university, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126813
- Sponsor's protocol ID
- POUR-RCT
- Acronym
- POUR-RCT
- Status last verified
- Oct 2015
- First submitted
- 24 Apr 2014
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Bladder Catheterization in Fast-track Hip and Knee Arthroplasty - What is the Optimal Bladder Volume? A Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT02126813
- Acronym / sponsor ID
- POUR-RCT / POUR-RCT
- Conditions
- Postoperative Urinary Retention (POUR)
- Keywords
- Postoperative urinary retention, Fast-track total hip (THA) and knee arthroplasty (TKA), Urinary bladder volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- May 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 30 Apr 2014 (estimated)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 500 ml. | Active comparator | Procedure: Current used interventional threshold for urinary bladder catheterization (500 ml), Device: Intermittent bladder catheterA bladder volume of 500 ml. or more, and incapability of voluntary micturition, is used as interventional threshold for urinary bladder catheterization. |
| 800 ml | Experimental | Procedure: increased interventional threshold for urinary bladder catheterization (800 ml), Device: Intermittent bladder catheterA bladder volume of 800 ml. or more, and incapability of voluntary micturition, is used as interventional threshold for urinary bladder catheterization. |
Who may qualify
- Ages
- 18 to 125 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- planned for elective total hip or knee arthroplasty
- given written informed consent for participation
Key exclusion criteria (7 listed)
- can't co-operate to participation
- can't speak or understand danish
- preoperative use of urinary bladder catheterization
- using haemodialysis
- previous cystectomy
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 |
|---|---|---|
| increased interventional threshold for urinary bladder catheterization (800 ml) | Procedure or surgery | 800 ml |
| Current used interventional threshold for urinary bladder catheterization (500 ml) | Procedure or surgery | 500 ml. |
| Intermittent bladder catheter | Device | 500 ml., 800 ml |
Primary outcome
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
3 secondary outcomes
Incidence of urinary tract infections
Time frame: within the first 30 days after surgery
Number of voiding difficulties acquired postoperatively
Time frame: within the first 30 days postoperatively
Number of readmissions due to urological issues (including urosepsis)
Time frame: Within the first 30 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
Related trials for Postoperative Urinary Retention (POUR)
RecruitingEarly Phase 1
Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery
Urinary Retention
Recruiting
Electroacupuncture on Postoperative Urinary Retention After Radical Surgery for Cervical Cancer
Postoperative Urinary Retention (POUR)
Not yet recruiting
Efficacy of Acupuncture for Postoperative Urinary Retention Following Radical Hysterectomy for Cervical Cancer
Postoperative Urinary Retention (POUR)
Active, not recruiting
Effect of IV Dexamethasone on Post-op Urinary Retention After Spinal Anesthesia
Post Operative Urinary Retention, Spinal Aneshtesia
RecruitingPhase 1/2
Post-operative Urinary Retention (POUR) Following Thoracic Surgery
Urinary Retention
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.
Lars Bjerregaard, MD principal investigator
Rigshospitalet, Copenhagen university, Denmark
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing increased interventional threshold for urinary bladder catheterization (800 ml), Current used interventional threshold for urinary bladder catheterization (500 ml) and Intermittent bladder catheter in people with Postoperative Urinary Retention (POUR), run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 28 Oct 2015.