Back to resultsA Trial of Different Methods for Bladder Drainage in Hip Surgery Patients
Primary Purpose
Urinary Tract Infections
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Intermittent urinary catheterisation
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Tract Infections focused on measuring urinary tract infections, urinary catheterisation
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing hip fracture surgery or hip replacement due to arthrosis
- Age 50 years and above
Exclusion Criteria:
- Patients with an indwelling catheter in situ
- Cognitive impairment
Sites / Locations
- Dept of Orthopaedic Surgery at Örebro University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Indwelling urinary catheter
Intermittent urinary catheterisation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Nosocomial urinary tract infection
Secondary Outcome Measures
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01333254
Brief Title
A Trial of Different Methods for Bladder Drainage in Hip Surgery Patients
Official Title
A Randomised Controlled Trial Comparing Different Methods for Short-Term Bladder Drainage in Patients With Hip Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Örebro County
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 and indwelling catheterisation respectively.
costs and health-effects differ between the patient groups.
experiences of urinary catheterisation differ between the patient groups
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
urinary tract infections, urinary catheterisation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Indwelling urinary catheter
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intermittent urinary catheterisation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intermittent urinary catheterisation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Time to normal bladder function
Description
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
Time Frame
Hours after surgery (participants will be followed for the duration of hospital stay, about 5-10 days)
Title
Costs for material and labour related to urinary catheterisation and nosocomial UTI during the first year after hip surgery
Description
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.
Time Frame
During time in hospital and up to 1 year after discharge
Title
Health effects during the first year after hip surgery
Description
The health-effects will be evaluated by EQ5D and SF-36 at discharge, 4 weeks, 4 months and 1 year after discharge.
Time Frame
Before discharge, 4 weeks, 4 months and 1 year after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing hip fracture surgery or hip replacement due to arthrosis
Age 50 years and above
Exclusion Criteria:
Patients with an indwelling catheter in situ
Cognitive impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Hälleberg Nyman, RN, MSc
Organizational Affiliation
Örebro University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Orthopaedic Surgery at Örebro University Hospital
City
Örebro
ZIP/Postal Code
SE-70185
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Trial of Different Methods for Bladder Drainage in Hip Surgery Patients
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