Bacteriuria and Indwelling Urinary Catheter.

NCT05039203 | Active Not Recruiting

• 1 other identifier: 2021-02410
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 2

Brief Summary

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?

Conditions

Bacteriuria Asymptomatic; Urinary Tract Infections

Keywords

Urinary Catheter

Outcome Measures

Primary Outcomes (1)

• Symptomatic bacteriuria (urinary tract infection)

  Clinical diagnosis of urinary tract infection by a physician

  Four weeks

Secondary Outcomes (2)

• Asymptomatic bacteriuria (ABU)

  One day

• Persistence of ABU

  Four weeks

Study Arms (2)

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

Control group

Inpatients without an IUC at admission to a rehabilitation clinic for persons ≥65 years in Sweden

Interventions

Indwelling urinary catheter DEVICE

Removal of indwelling urinary catheter

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (2)

Geriatric Department, Södertälje Hospital

Södertälje, Sweden

Location

Geriatric Department, Danderyd Hospital

Stockholm, Sweden

Location

Related Publications (1)

• Kulbay A, Joelsson-Alm E, Amilon K, Tammelin A. Asymptomatic bacteriuria and urinary tract infection in geriatric inpatients after indwelling urinary catheter removal: a descriptive two-centre study. Infect Prev Pract. 2024 Oct 24;6(4):100411. doi: 10.1016/j.infpip.2024.100411. eCollection 2024 Dec.

  PMID: 39583881 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples for culture

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 9, 2021
• Study Start: May 24, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

SE (2)