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

• Conditions: Type2diabetes, SGLT2 Inhibitor, Urinary Tract Infection
• Interventions: Diagnostic Test: urine culture and urinalysis

• Registration Number: NCT05520684
• Lead Sponsor: Trabzon Arakli Bayram Halil Public Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-15
• Status Verified: 2022-08
• Study First Submitted: 2022-08-26
• Study First Submitted QC: 2022-08-26
• Last Update Submitted: 2022-08-29
• Study First Posted: 2022-08-30
• Last Update Posted: 2022-09-01
• Primary Completion: 2022-11-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
positive for bacteriuria/ urinalysis abnormality	urine culture and urinalysis	The patients who have any growth in urine culture or urinalysis abnormality at the initiation of SGLT2 inhibitor (dapagliflozin or empagliflozin)
negative for bacteriuria/ urinalysis abnormality	urine culture and urinalysis	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)

Primary Outcome Measures

Name	Time	Method
Urinary tract infection	3 months	Number of participants with urinary tract infection - Any urinary tract infection treated or diagnosed by the physician clinically or by testing

Trial Locations

Locations (1)

Trabzon Araklı Bayram Halil Public Hospital; 🇹🇷 Trabzon, Turkey