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Assessing the efficacy of Empagliflozin in ameliorating urinary symptoms and urodynamic parameters of patients with benign prostatic hyperplasia and diabetes

Assessing the efficacy of Empagliflozin in ameliorating urinary symptoms and urodynamic parameters of patients with benign prostatic hyperplasia and diabetes, a double-blinded placebo-controlled randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250401065188N1
Enrollment
50
Registered
2025-04-10
Start date
2025-04-21
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign prostatic hyperplasia.

Interventions

Intervention 1: Intervention group: In the intervention group, the main drug empagliflozin is prescribed at a dose of 25 mg daily for 3 months along with metformin at a dose of 500 to 2000 mg daily fo

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: Male patients above ?? years old, with evidence of type ? diabetes (fasting blood sugar = ??? mg/dL, HbA?c = ?.?%, or ?-hour post-prandial blood glucose = ??? mg/dL) and sonographic evidence of benign prostatic hyperplasia Evidence of lower urinary tract symptoms (IPSS Score moderate) Sonographic evidence of benign prostatic hyperplasia

Exclusion criteria

Exclusion criteria: Patients younger than ?? years old Having type ? diabetes mellitus Need for insulin use (HbA?c= ??.?%, weight loss, or fasting blood glucose = ??? mg/dL) Having the need for SGLT?i therapy for other reasons such as diabetic nephropathy or congestive heart failure, history of chronic kidney disease or hepatic impairment IPSS score: "severe" (due to need for other medications or surgery) Unwillingness to participate in the study

Design outcomes

Primary

MeasureTime frame
Lower urinary tract symptoms. Timepoint: At the beginning of the study, three months after taking the drug. Method of measurement: IPSS Questionnaire.

Secondary

MeasureTime frame
Peak urinary flow rate. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Uroflowmetry.;Post void residual. Timepoint: At the beginning of the study and 3 months later. Method of measurement: KUB ultrasound.;PSA. Timepoint: At the beginning of the study and 3 months later. Method of measurement: blood sample study.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactArman Hosseini

Shiraz University of Medical Sciences

ahf1374@yahoo.com+98 71 3649 9622

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026