Bacteriuria and Indwelling Urinary Catheter.

November 19, 2024 updated by: Ann Tammelin, Region Stockholm

The Risk of Symptomatic Bacteriuria and Persistence of Asymptomatic Bacteriuria After Removal of an Indwelling Urinary Catheter- a Prospective Observational Study Among Elderly Inpatients.

Investigation of 1. The incidence of symptomatic bacteriuria during four weeks after removal of an IUC in inpatients at a rehabilitation clinic for patients ≥ 65 years compared with the incidence of symptomatic bacteriuria among inpatients not treated with an IUC and 2. For how long does ABU persist in inpatients at a rehabilitation clinic for patients

≥ 65 years during a follow-up time of four weeks after IUC-removal?

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

196

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Geriatric Department, Danderyd Hospital
      • Södertälje, Sweden
        • Geriatric Department, Södertälje Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients admitted to a rehabilitation clinic for patients ≥ 65 years in Stockholm County, Sweden.

Description

Inclusion Criteria:

  • Admission to a rehabilitation clinic for patients ≥ 65 years in Stockholm County, Sweden
  • Ability to understand oral and written instructions in Swedish
  • Ability to produce a voided urine-sample

Exclusion Criteria:

  • Severe cognitive failure and/or disability to understand oral and written instructions in Swedish according to the healthcare-personnel's judgment at the ward
  • End-of-life care
  • Physical disability to produce voided urine-samples
  • Ongoing antimicrobial treatment for symptomatic bacteriuria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention group
Inpatients with an indwelling urinary catheter (IUC) at admission to a rehabilitation clinic for persons ≥65 years in Sweden. Intervention is removal of the IUC.
Device: Indwelling urinary catheter
Removal of indwelling urinary catheter
Control group
Inpatients without an IUC at admission to a rehabilitation clinic for persons ≥65 years in Sweden

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic bacteriuria (urinary tract infection)
Time Frame: Four weeks
Clinical diagnosis of urinary tract infection by a physician
Four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asymptomatic bacteriuria (ABU)
Time Frame: One day
Prevalence of ABU at the point of removal of an IUC compared with patients without IUC
One day
Persistence of ABU
Time Frame: Four weeks
For how long does ABU persist after IUC-removal
Four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2022

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

September 1, 2021

First Submitted That Met QC Criteria

September 1, 2021

First Posted (Actual)

September 9, 2021

Study Record Updates

Last Update Posted (Actual)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-02410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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