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Completed

NCT Number: NCT01333254

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

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

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Orthopaedic Surgery at Örebro University Hospital

Örebro, SE-70185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent urinary catheterisation

Procedure

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 outcomes

  1. 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 outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Apr 11, 2011
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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