SGLT2 InhibitorsNCT07716774
SGLT-2 Inhibitors and Lower Urinary Tract Symptoms
An observational study of SGLT2 Inhibitors and Lower Urinary Track Symptoms, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SGLT2 Inhibitors, Lower Urinary Track Symptoms, Overactive Bladder
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 1 Dec 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adults (≥18 years of age)
- Patients with type 2 diabetes mellitus newly initiated on oral SGLT-2 inhibitor therapy
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine Urology Department
Istanbul, Pendik, 34854
About this study
Official title: 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.
- Being tested
- No Intervention: Observational Cohort
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No Intervention: Observational Cohort
| Study group | Role | What they receive |
|---|---|---|
| sglt2 inhibitor group | Not described Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Urinary Tract Symptoms
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Jul 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SGLT2 InhibitorsStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarik Emre Sener, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716774
- Sponsor's protocol ID
- MAR.UAD.0035
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT07716774
- Acronym / sponsor ID
- MAR.UAD.0035
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sglt2 inhibitor group | – | Other: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adults (≥18 years of age)
- Patients with type 2 diabetes mellitus newly initiated on oral SGLT-2 inhibitor therapy
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo Intervention: Observational Cohort | Other | sglt2 inhibitor group |
Primary outcome
Lower Urinary Tract Symptoms
Time frame: one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SGLT2 Inhibitors and Lower Urinary Track Symptoms, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Urinary Tract Symptoms (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.