SGLT-2 Inhibitors and Lower Urinary Tract Symptoms

This prospective observational study aims to evaluate the effects of sodium-glucose cotransporter 2 (SGLT-2) inhibitors on lower urinary tract symptoms (LUTS) in patients with type 2 diabetes mellitus. Patients who are newly initiated on SGLT-2 inhibitor therapy as part of routine clinical care will be evaluated at baseline and after one month using a 3-day bladder diary and the Overactive Bladder Questionnaire (OAB-v8). Changes in storage symptoms, including urinary frequency, urgency, nocturia, and urinary incontinence, will be assessed to better characterize the impact of SGLT-2 inhibitor therapy on LUTS.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

SGLT2 Inhibitors Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Track Symptoms Lower Urinary Tract Symptoms Male Urogenital Diseases Overactive Bladder Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University School of Medicine Urology Department

Istanbul, Pendik, 34854, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults (≥18 years of age)
Patients with type 2 diabetes mellitus newly initiated on oral SGLT-2 inhibitor therapy

Exclusion criteria

Age <18 years
Patients with insulin-dependent diabetes mellitus (IDDM)
Patients with diabetes-related complications (e.g., diabetic nephropathy, retinopathy, or vasculopathy)
Patients receiving anticholinergic or α-blocker therapy for lower urinary tract symptoms (LUTS)
History of urinary incontinence surgery (including any surgical procedure involving the urethral sphincter, bladder neck, pelvic floor, or pelvic nerves)
Patients with urinary tract infection (UTI)

Treatment and study plan

No Intervention: Observational Cohort

Other

No Intervention: Observational Cohort

Primary outcomes

Lower Urinary Tract Symptoms

Time frame: one month

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Lower Urinary Tract Symptoms

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jul 21, 2026
Registry last updated: Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting