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

Trabzon Arakli Bayram Halil Public Hospital

Status: Enrolling

Conditions: Type2diabetes, SGLT2 Inhibitor, Urinary Tract Infection

Treatments: Diagnostic Test: urine culture and urinalysis

Study type: Observational

Funder types: Other

Identifiers

NCT05520684

6111449

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

positive for bacteriuria/ urinalysis abnormality

Description:

The patients who have any growth in urine culture or urinalysis abnormality at the initiation of SGLT2 inhibitor (dapagliflozin or empagliflozin)

Treatment:

Diagnostic Test: urine culture and urinalysis

negative for bacteriuria/ urinalysis abnormality

Description:

The patients who do not have growth in urine culture or do not have abnormality in urinalysis at the initiation of SGLT2 inhibitor (dapagliflozin or empagliflozin)

Treatment:

Diagnostic Test: urine culture and urinalysis