SGLT-2 Inhibitors and Lower Urinary Tract Symptoms

NCT07716774 | Active Not Recruiting

• 1 other identifier: MAR.UAD.0035
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SGLT2 Inhibitors; Lower Urinary Track Symptoms; Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Lower Urinary Tract Symptoms

  one month

Study Arms (1)

sglt2 inhibitor group

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No Intervention: Observational Cohort

sglt2 inhibitor group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine Urology Department

Istanbul, Pendik, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)