Postoperative Urinary RetentionNCT02133768
Routine Bladder Catheterisation Through Fast-track Hip and Knee Replacement - What Are the Consequences?
An observational study of Postoperative Urinary Retention, run by Lundbeck Foundation at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Urinary Retention
- How many people
- 800 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to Jun 2016
- Phase
- Observational
- 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
Study population: Participating patients may help to clarify the consequences of using fixed bladder catheterisation of patients undergoing planned deployment of an artificial hip or knee. This will provide a basis to compare the effects of these practices with other treatment regimens, such as. intermittent once-bladder catheterisation in the postoperative period, which may contribute to the prevention and treatment of POUR can be optimized for all patients. The study is conducted as a non-interventional, observational study and all participants will receive the department's standard treatment.
Who may be able to join
- Patients must meet all the following criteria to be eligible to enroll in the study:
- Age >50 years.
- Patients scheduled for primary THA or TKA.
- Patients who have given verbal consent to participate in the study.
Who cannot join
- Patients who meet one or more of the following criteria may not be included in the study:
- Patients who can not cooperate with the study.
- Patients who do not understand or speak Danish.
- Patients who are permanent catheter carriers or use disposable bladder catheterisation.
- Patients on hemodialysis.
- Urine Derivative patients.
- Pregnancy or childbirth within 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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:
- The number of patients in need of re-catheterization due POUR
- The number of patients in which the removal of KAD was not carried out within 24 hours.
- The number of urinary tract infections from surgery to postoperative day (POD) 30
- The number of patients with new-onset urinary discomfort at POD 30 (Increase in IPSS score).
- The number of urological-related readmissions (including urosepsis) within POD 30
- Conditions
- Postoperative Urinary Retention
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients needing re-catheterization
The need for re-catheterization will be asses on a daily basis until discharge from hospital (median 3 days from surgery)
Measured: From removal of urinary catheter at first postoperative day and untill discharge from hospital
Secondary outcomes (4)
Number of patients who did not get their urinary catheter removed on the first postoperative day
Measured: within the first 24 hours after surgery
Number of urinary tract infections
Assessed on a daily basis during admision and detailed telephone interview on day 30 after surgery
Measured: within the first 30 days after surgery
Number of patients developing postoperative micturition difficulties
All patients completes a questionary preoperatively (the international prostate symptom score) and the same questionary again on day 30 after surgery.
Measured: From day 1 to day 30 after surgery
Number of re-admission due to urological problems, including urosepsis
assessed by telephone interview on day 30 after surgery
Measured: within the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Urinary RetentionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundbeck Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Homilius, Lundbeck Foundation
- Investigators
- Morten Homilius, Principal investigator, Department of orthopedic, Regional Hospital Holstebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133768
- Sponsor's protocol ID
- Bladder cathererisation
- Other IDs
- Lundbeck Foundation
- Status last verified
- Mar 2017
- First submitted
- 8 Apr 2014
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bjerregaard LS, Homilius M, Bagi P, Hansen TB, Kehlet H. Indwelling urinary catheterisation may increase risk of complications in hip and knee arthroplasty. Dan Med J. 2019 Apr;66(4):A5538.
PubMed 30910003
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Bladder Catheterisation Through Fast-track Hip and Knee Replacement - What Are the Consequences?
- ClinicalTrials.gov ID
- NCT02133768
- Acronym / sponsor ID
- Bladder cathererisation
- Conditions
- Postoperative Urinary Retention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Lundbeck FoundationUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 May 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.
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:
- The number of patients in need of re-catheterization due POUR
- The number of patients in which the removal of KAD was not carried out within 24 hours.
- The number of urinary tract infections from surgery to postoperative day (POD) 30
- The number of patients with new-onset urinary discomfort at POD 30 (Increase in IPSS score).
- The number of urological-related readmissions (including urosepsis) within POD 30
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participating patients may help to clarify the consequences of using fixed bladder catheterisation of patients undergoing planned deployment of an artificial hip or knee. This will provide a basis to compare the effects of these practices with other treatment regimens, such as. intermittent once-bladder catheterisation in the postoperative period, which may contribute to the prevention and treatment of POUR can be optimized for all patients. The study is conducted as a non-interventional, observational study and all participants will receive the department's standard treatment.
Key inclusion criteria (4 listed)
- Patients must meet all the following criteria to be eligible to enroll in the study:
Key exclusion criteria (7 listed)
- Patients who meet one or more of the following criteria may not be included in the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients needing re-catheterization
Time frame: From removal of urinary catheter at first postoperative day and untill discharge from hospital
The need for re-catheterization will be asses on a daily basis until discharge from hospital (median 3 days from surgery)
4 secondary outcomes
Number of patients who did not get their urinary catheter removed on the first postoperative day
Time frame: within the first 24 hours after surgery
Number of urinary tract infections
Time frame: within the first 30 days after surgery
Number of patients developing postoperative micturition difficulties
Time frame: From day 1 to day 30 after surgery
Number of re-admission due to urological problems, including urosepsis
Time frame: within the first 30 days after surgery
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 7 Mar 2017.
- Derived from this study: PubMed 30910003Bjerregaard LS, Homilius M, Bagi P, Hansen TB, Kehlet H. Indwelling urinary catheterisation may increase risk of complications in hip and knee arthroplasty. Dan Med J. 2019 Apr;66(4):A5538.
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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.
Morten Homilius principal investigator
Department of orthopedic, Regional Hospital Holstebro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Urinary Retention, run by Lundbeck Foundation at 1 site 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 4 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 7 Mar 2017. 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 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 needing re-catheterization (time frame: From removal of urinary catheter at first postoperative day and untill discharge from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02133768, which also lists 1 linked publication.
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 7 Mar 2017.