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

Urinary Tract Infection Risk in Women With Asymptomatic Bacteriuria or Urinalysis Abnormality at the Initiation of SGLT2 Inhibitors

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05520684
Enrollment
120
Registered
2022-08-30
Start date
2022-02-15
Completion date
2023-01-01
Last updated
2022-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type2diabetes, SGLT2 Inhibitor, Urinary Tract Infection

Brief 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.

Interventions

DIAGNOSTIC_TESTurine culture and urinalysis

urine culture and urinalysis

Sponsors

Trabzon Arakli Bayram Halil Public Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frameDescription
Urinary tract infection3 monthsNumber of participants with urinary tract infection - Any urinary tract infection treated or diagnosed by the physician clinically or by testing

Countries

Turkey (Türkiye)

Contacts

Primary ContactErman Akkus, MD
erman_akkus@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026