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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University Hospital Orebro.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT01333254
First received: April 1, 2011
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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 Intervention
Urinary Tract Infections
Procedure: Intermittent urinary catheterisation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial Comparing Different Methods for Short-Term Bladder Drainage in Patients With Hip Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital Orebro:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to normal bladder function [ Time Frame: Hours after surgery (participants will be followed for the duration of hospital stay, about 5-10 days) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The health-effects will be evaluated by EQ5D and SF-36 at discharge, 4 weeks, 4 months and 1 year after discharge.


Estimated Enrollment: 160
Study Start Date: September 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333254

Locations
Sweden
Dept of Orthopaedic Surgery at Örebro University Hospital
Örebro, Sweden, SE-70185
Sponsors and Collaborators
University Hospital Orebro
Investigators
Principal Investigator: Maria Hälleberg Nyman, RN, MSc Örebro University Hospital, Sweden
  More Information

No publications provided

Responsible Party: Maria Hälleberg Nyman, RN, MSc, Örebro University Hospital
ClinicalTrials.gov Identifier: NCT01333254     History of Changes
Other Study ID Numbers: 2009-075
Study First Received: April 1, 2011
Last Updated: June 22, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital Orebro:
urinary tract infections
urinary catheterisation

Additional relevant MeSH terms:
Infection
Urinary Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on November 24, 2014