SGLT-2 Inhibitors and Lower Urinary Tract Symptoms

July 16, 2026 updated by: Tarik Emre Sener, Marmara University

Effects of Sodium-Glucose Cotransporter 2 Inhibitors on 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Pendik
      • Istanbul, Pendik, Turkey (Türkiye), 34854
        • Marmara University School of Medicine Urology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adults (≥18 years) with type 2 diabetes mellitus who are newly prescribed oral SGLT-2 inhibitor therapy during routine clinical practice. Eligible patients without pre-existing conditions or treatments that could significantly affect lower urinary tract symptoms will be prospectively followed for one month. Lower urinary tract symptoms will be assessed using a 3-day bladder diary and the OAB-v8 questionnaire at baseline and at the one-month follow-up.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
sglt2 inhibitor group
Other: No Intervention: Observational Cohort
No Intervention: Observational Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lower Urinary Tract Symptoms
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 16, 2026

First Submitted That Met QC Criteria

July 16, 2026

First Posted (Actual)

July 21, 2026

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAR.UAD.0035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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