NCT01333254

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

October 5, 2016

Status Verified

October 1, 2016

Enrollment Period

1.7 years

First QC Date

April 1, 2011

Last Update Submit

October 4, 2016

Conditions

Urinary Tract Infections

Keywords

urinary tract infectionsurinary catheterisation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Time to normal bladder function

    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

    During time in hospital and up to 1 year after discharge

  • Health effects during the first year after hip surgery

    Before discharge, 4 weeks, 4 months and 1 year after discharge

Study Arms (2)

Indwelling urinary catheter

NO INTERVENTION

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.

Intermittent urinary catheterisation

EXPERIMENTAL

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

Interventions

Intermittent urinary catheterisationPROCEDURE

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.

Intermittent urinary catheterisation

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing hip fracture surgery or hip replacement due to arthrosis
  • Age 50 years and above

You may not qualify if:

  • Patients with an indwelling catheter in situ
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Orthopaedic Surgery at Örebro University Hospital

Örebro, SE-70185, Sweden

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Maria Hälleberg Nyman, RN, MSc

    Örebro University Hospital, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 1, 2011

First Posted

April 11, 2011

Study Start

September 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2012

Last Updated

October 5, 2016

Record last verified: 2016-10

Locations

SE(1)