Postoperative Urinary RetentionNCT03341819
Comparative Study Between Retained and Non-retained Urinary Catheter in Total Knee Arthorplasty With Epidural Anesthesia
A study testing Total knee arthroplasty and Urinary Catheterization in people with Postoperative Urinary Retention and Urinary Tract Infections, run by Navamindradhiraj University at 1 site in Thailand.
Trial summary
The purpose of this study is to compare the prevalence of postoperative urinary retention between retained and non-retained urinary catheter in total knee arthorplasty with epidural anesthesia Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Postoperative Urinary Retention, Urinary Tract Infections, Epidural Anesthesia
- What is being tested?
- Total knee arthroplasty and Urinary Catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteThailand
- Study dates
- 6 Nov 2017to 25 Oct 2019
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty
Who cannot join
- History of renal disease
- History of urinary tract infection
- History of previous urinary tract surgery
- Benign prostatic hypertrophy
- Bilateral total knee arthroplasty
- Revision total knee arthroplasty
- Patients who need intraoperative monitoring of urine output
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the prevalence of postoperative urinary retention between retained and non-retained urinary catheter in total knee arthorplasty with epidural anesthesia
- Being tested
- Total knee arthroplasty, Urinary Catheterization
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)
Urinary CatheterizationProcedure or surgery
Urinary catheterization is a latex, polyurethane, or silicone tube known as a urinary catheter is inserted into a patient's bladder via the urethra. Catheterization allows the patient's urine to drain freely from the bladder for collection.
| Study group | Role | What they receive |
|---|---|---|
| Retained Urinary Catheter | Active comparator | Not described Receives: Procedure: Total knee arthroplasty; Procedure: Urinary Catheterization |
| Non-retained Urinary Catheter | Experimental | Not described Receives: Procedure: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative urinary retention
Patients who didn't void within 6 hours with suprapubic discomfort and had a urinary volume 400 mL or more confirmed by single intermittent catheterization
Measured: 6 hours after surgery and 6 hours after remove urinary catherter
Secondary outcomes (1)
urinary tract infection
An infection of the kidney, ureter, bladder, or urethra. The symptoms are burning with urination and having to urinate frequently and fever > 38° C. Urine culture shows a bacterial colony count of greater than or equal to ten to the fifth colony-forming units per mL of a typical urinary tract organism.
Measured: 7 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 posted14 Nov 2017
- Study start6 Nov 2017
- Primary completion5 Apr 2019
- Study completion25 Oct 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Navamindradhiraj University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satit Thiengwittayaporn, Navamindradhiraj University
- Investigators
- Satit Thiengwittayaporn, M.D., Principal investigator, Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341819
- Sponsor's protocol ID
- COA 126/2560
- Status last verified
- Nov 2019
- First submitted
- 9 Nov 2017
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thiengwittayaporn S, Uthaitas P, Hongku N, Tunyasuwanakul R, Limphunudom P, Leelachiewchankul F. Indwelling urinary catheterization was unnecessary in non-drainage total knee arthroplasty: a randomized controlled trial. Arch Orthop Trauma Surg. 2021 Mar;141(3):469-476. doi: 10.1007/s00402-020-03677-z. Epub 2020 Nov 12.
PubMed 33180187
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Retained and Non-retained Urinary Catheter in Total Knee Arthorplasty With Epidural Anesthesia
- ClinicalTrials.gov ID
- NCT03341819
- Acronym / sponsor ID
- COA 126/2560
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Navamindradhiraj UniversityUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 14 Nov 2017 (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.
The purpose of this study is to compare the prevalence of postoperative urinary retention between retained and non-retained urinary catheter in total knee arthorplasty with epidural anesthesia
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retained Urinary Catheter | Active comparator | Procedure: Total knee arthroplasty, Procedure: Urinary Catheterization |
| Non-retained Urinary Catheter | Experimental | Procedure: Total knee arthroplasty |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty
Key exclusion criteria (7 listed)
- History of renal disease
- History of urinary tract infection
- History of previous urinary tract surgery
- Benign prostatic hypertrophy
- Bilateral total knee arthroplasty
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 |
|---|---|---|
| Total knee arthroplastyA surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses) | Procedure or surgery | Non-retained Urinary Catheter, Retained Urinary Catheter |
| Urinary CatheterizationUrinary catheterization is a latex, polyurethane, or silicone tube known as a urinary catheter is inserted into a patient's bladder via the urethra. Catheterization allows the patient's urine to drain freely from the bladder for collection. | Procedure or surgery | Retained Urinary Catheter |
Primary outcome
postoperative urinary retention
Time frame: 6 hours after surgery and 6 hours after remove urinary catherter
Patients who didn't void within 6 hours with suprapubic discomfort and had a urinary volume 400 mL or more confirmed by single intermittent catheterization
1 secondary outcome
urinary tract infection
Time frame: 7 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 25 Nov 2019.
- Derived from this study: PubMed 33180187Thiengwittayaporn S, Uthaitas P, Hongku N, Tunyasuwanakul R, Limphunudom P, Leelachiewchankul F. Indwelling urinary catheterization was unnecessary in non-drainage total knee arthroplasty: a randomized controlled trial. Arch Orthop Trauma Surg. 2021 Mar;141(3):469-476. doi: 10.1007/s00402-020-03677-z. Epub 2020 Nov 12.
- 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.
Satit Thiengwittayaporn, M.D. principal investigator
Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty and Urinary Catheterization in people with Postoperative Urinary Retention and Urinary Tract Infections, run by Navamindradhiraj University at 1 site in Thailand.
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 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 25 Nov 2019. 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 Thailand. 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?
postoperative urinary retention (time frame: 6 hours after surgery and 6 hours after remove urinary catherter). 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 NCT03341819, 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 25 Nov 2019.