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

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

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Procedure: Intermittent urinary catheterisation

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden, SE-70185
    • Dept of Orthopaedic Surgery at Örebro University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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)
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
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

Collaborators and Investigators

• Sponsor: Region Örebro County
• Investigators: Principal Investigator: Maria Hälleberg Nyman, RN, MSc, Örebro University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: April 1, 2011
• First Submitted That Met QC Criteria: April 8, 2011
• First Posted (Estimate): April 11, 2011

Study Record Updates

• Last Update Posted (Estimate): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 4, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: urinary tract infections; urinary catheterisation
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections
• Other Study ID Numbers: 2009-075