A Trial of Different Methods for Bladder Drainage in Hip Surgery Patients

Not Applicable

Completed

• Conditions: Urinary Tract Infections
• Interventions: Procedure: Intermittent urinary catheterisation

• Registration Number: NCT01333254
• Lead Sponsor: Region Örebro County

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-08
• Study First Posted: 2011-04-11
• Primary Completion: 2011-06
• Study Completion: 2012-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent urinary catheterisation	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.

Primary Outcome Measures

Name	Time	Method
Nosocomial urinary tract infection	Urine culture will be collected at admission and before discharge from the orthopaedic ward (about 5-10 days after admission)

Secondary Outcome Measures

Name	Time	Method
Health effects during the first year after hip surgery	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.
Time to normal bladder function	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	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.

Trial Locations

Locations (1)

Dept of Orthopaedic Surgery at Örebro University Hospital; 🇸🇪 Örebro, Sweden