Asymptomatic Bacteriuria, Urinalysis Abnormality at the Initiation of SGLT2 Inhibitors and UTI Risk

Last updated: August 29, 2022
Sponsor: Trabzon Arakli Bayram Halil Public Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urinary Tract Infections

Treatment

N/A

Clinical Study ID

NCT05520684
6111449
  • Ages > 18
  • Female

Study Summary

The SGLT2 inhibitors have changed the treatment of type 2 diabetes mellitus in recent years, especially in patients with cardiovascular or renal disease. However, the association between SGLT2 inhibitors and urinary tract infection (UTI) risk is controversial. Moreover, it is not known whether asymptomatic bacteriuria or urinalysis abnormality at the initiation of SGLT2 inhibitors are risk factors for UTI in women. There is not enough data to recommend or not to recommend for performing urinalysis or urine culture test before initiation of SGLT2 inhibitors. The aim of the study is to investigate the effect of asymptomatic bacteriuria or urinalysis abnormality at the initiation of SGLT2 inhibitors on UTI risk in a prospective cohort of women with type 2 diabetes mellitus.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female
  • >18 years old
  • Type 2 Diabetes Mellitus
  • Initiated SGLT2 inhibitors
  • Available informed consent

Exclusion

Exclusion Criteria:

  • Having urinary tract or genital tract symptoms at the enrollment
  • Treated for urinary tract or genital tract infection in the last 3 months

Study Design

Total Participants: 120
Study Start date:
February 15, 2022
Estimated Completion Date:
January 01, 2023

Connect with a study center

  • Trabzon Araklı Bayram Halil Public Hospital

    Trabzon,
    Turkey

    Active - Recruiting

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