Urinary Tract InfectionsNCT01333254
A Trial of Different Methods for Bladder Drainage in Hip Surgery Patients
A study testing Intermittent urinary catheterisation in people with Urinary Tract Infections, run by Region Örebro County at 1 site in Sweden.
Trial summary
The aim of the project is to evaluate differences between intermittent and indwelling catheterisation in patients with hip surgery. Specific objectives are to determine whether: frequencies of urinary tract problems in hospital and up to one year after discharge differ between patient groups treated with intermittent… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Intermittent urinary catheterisation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2009to Jun 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing hip fracture surgery or hip replacement due to arthrosis
- Age 50 years and above
Who cannot join
- Patients with an indwelling catheter in situ
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Orthopaedic Surgery at Örebro University Hospital
Örebro, SE-70185
About this study
Official title: A Randomised Controlled Trial Comparing Different Methods for Short-Term Bladder Drainage in Patients With Hip Surgery
The aim of the project is to evaluate differences between intermittent and indwelling catheterisation in patients with hip surgery.
Specific objectives are to determine whether:
- frequencies of urinary tract problems in hospital and up to one year after discharge differ between patient groups treated with intermittent and indwelling catheterisation respectively.
- costs and health-effects differ between the patient groups.
- experiences of urinary catheterisation differ between the patient groups
- Conditions
- Urinary Tract Infections
- Being tested
- Intermittent urinary catheterisation
- Keywords
- urinary tract infections, urinary catheterisation
- 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.
Intermittent urinary catheterisationProcedure or surgery
Patients randomised to the I group will urinate either in a toilet or in a bedpan or a diaper when needed. Bladder scan control will be performed on these patients at least every four hour. If the patient is unable to urinate and bladder scan indicates ≥ 450 ml urine in the bladder, the patient will be intermittent catheterised.
| Study group | Role | What they receive |
|---|---|---|
| Indwelling urinary catheter | No intervention | Patients in this group with hip fracture will get an indwelling catheter at arrival to the orthopaedic ward. The patients with arthrosis get the indwelling catheter in the morning at the day of surgery. In both cases the indwelling catheter is inserted after shower with skin disinfectant. The catheter system is kept close. The catheter will be removed in the morning on day 2 after surgery. The patients are bladder-scanned every four-hour until normal bladder function is recaptured. If the bladder volume exceeds 400ml and the patient is unable to urinate, the patient will be re-catheterised. The procedure of the patients in this arm is in accordance with common practice in the Orthopaedic clinic. |
| Intermittent urinary catheterisation | Experimental | Patients randomised to this arm will urinate either in a toilet or in a bedpan or a diaper when needed. Bladder scan control will be performed on these patients at least every four hour. If the patient is unable to urinate and bladder scan indicates ≥ 400 ml urine in the bladder, the patient will be intermittent catheterised. Receives: Procedure: Intermittent urinary catheterisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nosocomial urinary tract infection
Measured: Urine culture will be collected at admission and before discharge from the orthopaedic ward (about 5-10 days after admission)
Secondary outcomes (3)
Time to normal bladder function
Normal bladder function was in this study defined as a post-micturition residual urine volume of 150ml or less.The patients will be bladder-scanned every fourth hour until normal bladder function is recaptured
Measured: Hours after surgery (participants will be followed for the duration of hospital stay, about 5-10 days)
Costs for material and labour related to urinary catheterisation and nosocomial UTI during the first year after hip surgery
Costs will be considered for material and labour. The material costs include costs for catheters, material used when inserting catheters, material used when using the bladder scan, costs for clothes and bedding changed due to urine and diapers. Also costs for medication due to urinary problems will be registered. The labour costs included are time for urinary catheterisation, bladder scan, change of patients' clothes and bedding or diapers due to urine, consultation at the Urological department or to a general practitioner due to urinary problems and length of hospital stay.
Measured: During time in hospital and up to 1 year after discharge
Health effects during the first year after hip surgery
The health-effects will be evaluated by EQ5D and SF-36 at discharge, 4 weeks, 4 months and 1 year after discharge.
Measured: Before discharge, 4 weeks, 4 months and 1 year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startSep 2009
- Primary completionJun 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Halleberg Nyman, Region Örebro County
- Investigators
- Maria Hälleberg Nyman, RN, MSc, Principal investigator, Örebro University Hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333254
- Sponsor's protocol ID
- 2009-075
- Status last verified
- Oct 2016
- First submitted
- 1 Apr 2011
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing Different Methods for Short-Term Bladder Drainage in Patients With Hip Surgery
- ClinicalTrials.gov ID
- NCT01333254
- Acronym / sponsor ID
- 2009-075
- Conditions
- Urinary Tract Infections
- Keywords
- urinary tract infections, urinary catheterisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 Apr 2011 (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.
The aim of the project is to evaluate differences between intermittent and indwelling catheterisation in patients with hip surgery.
Specific objectives are to determine whether:
- frequencies of urinary tract problems in hospital and up to one year after discharge differ between patient groups treated with intermittent and indwelling catheterisation respectively.
- costs and health-effects differ between the patient groups.
- experiences of urinary catheterisation differ between the patient groups
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indwelling urinary catheter | No intervention | –Patients in this group with hip fracture will get an indwelling catheter at arrival to the orthopaedic ward. The patients with arthrosis get the indwelling catheter in the morning at the day of surgery. In both cases the indwelling catheter is inserted after shower with skin disinfectant. The catheter system is kept close. The catheter will be removed in the morning on day 2 after surgery. The patients are bladder-scanned every four-hour until normal bladder function is recaptured. If the bladder volume exceeds 400ml and the patient is unable to urinate, the patient will be re-catheterised. The procedure of the patients in this arm is in accordance with common practice in the Orthopaedic clinic. |
| Intermittent urinary catheterisation | Experimental | Procedure: Intermittent urinary catheterisationPatients randomised to this arm will urinate either in a toilet or in a bedpan or a diaper when needed. Bladder scan control will be performed on these patients at least every four hour. If the patient is unable to urinate and bladder scan indicates ≥ 400 ml urine in the bladder, the patient will be intermittent catheterised. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing hip fracture surgery or hip replacement due to arthrosis
- Age 50 years and above
Key exclusion criteria (2 listed)
- Patients with an indwelling catheter in situ
- Cognitive impairment
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 |
|---|---|---|
| Intermittent urinary catheterisationPatients randomised to the I group will urinate either in a toilet or in a bedpan or a diaper when needed. Bladder scan control will be performed on these patients at least every four hour. If the patient is unable to urinate and bladder scan indicates ≥ 450 ml urine in the bladder, the patient will be intermittent catheterised. | Procedure or surgery | Intermittent urinary catheterisation |
Primary outcome
Nosocomial urinary tract infection
Time frame: Urine culture will be collected at admission and before discharge from the orthopaedic ward (about 5-10 days after admission)
3 secondary outcomes
Time to normal bladder function
Time frame: Hours after surgery (participants will be followed for the duration of hospital stay, about 5-10 days)
Costs for material and labour related to urinary catheterisation and nosocomial UTI during the first year after hip surgery
Time frame: During time in hospital and up to 1 year after discharge
Health effects during the first year after hip surgery
Time frame: Before discharge, 4 weeks, 4 months and 1 year after discharge
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 5 Oct 2016.
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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.
Maria Hälleberg Nyman, RN, MSc principal investigator
Örebro University Hospital, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent urinary catheterisation in people with Urinary Tract Infections, run by Region Örebro County at 1 site in Sweden.
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 2 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 5 Oct 2016. 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 Sweden. 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?
Nosocomial urinary tract infection (time frame: Urine culture will be collected at admission and before discharge from the orthopaedic ward (about 5-10 days after admission)). 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 5 Oct 2016.