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

Urinary Tract Infections Clinical Trial

Official title:

A Randomised Controlled Trial Comparing Different Methods for Short-Term Bladder Drainage in Patients With Hip Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333254
• Other study ID #: 2009-075
• Status: Completed
• Phase: N/A
• First received: April 1, 2011
• Last updated: October 4, 2016
• Start date: September 2009
• Est. completion date: June 2012

Study information

• Verified date: October 2016
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical 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 and indwelling catheterisation respectively.

• costs and health-effects differ between the patient groups.

• experiences of urinary catheterisation differ between the patient groups

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Sweden	Dept of Orthopaedic Surgery at Örebro University Hospital	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nosocomial urinary tract infection		Urine culture will be collected at admission and before discharge from the orthopaedic ward (about 5-10 days after admission)	Yes
Secondary	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	Hours after surgery (participants will be followed for the duration of hospital stay, about 5-10 days)	Yes
Secondary	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.	During time in hospital and up to 1 year after discharge	No
Secondary	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.	Before discharge, 4 weeks, 4 months and 1 year after discharge	No