A Trial of Different Methods for Bladder Drainage in Hip Surgery Patients
|ClinicalTrials.gov Identifier: NCT01333254|
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : October 5, 2016
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
|Condition or disease||Intervention/treatment|
|Urinary Tract Infections||Procedure: Intermittent urinary catheterisation|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Controlled Trial Comparing Different Methods for Short-Term Bladder Drainage in Patients With Hip Surgery|
|Study Start Date :||September 2009|
|Primary Completion Date :||June 2011|
|Study Completion Date :||June 2012|
No Intervention: Indwelling urinary catheter
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.
Experimental: Intermittent urinary catheterisation
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.
Procedure: Intermittent urinary catheterisation
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.
- 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) ]
- Time to normal bladder function [ Time Frame: Hours after surgery (participants will be followed for the duration of hospital stay, about 5-10 days) ]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 [ Time Frame: During time in hospital and up to 1 year after discharge ]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 [ Time Frame: Before discharge, 4 weeks, 4 months and 1 year after discharge ]The health-effects will be evaluated by EQ5D and SF-36 at discharge, 4 weeks, 4 months and 1 year after discharge.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333254
|Dept of Orthopaedic Surgery at Örebro University Hospital|
|Örebro, Sweden, SE-70185|
|Principal Investigator:||Maria Hälleberg Nyman, RN, MSc||Örebro University Hospital, Sweden|