Tamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH | NCT07722884

NCT07722884

Overview

NCT ID: NCT07722884
Lead Sponsor: Ain Shams UniversityOTHER
Official Title: Safety and Efficacy of Tamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH
Brief Summary: This study aims to evaluate the short-term impact and clinical outcomes of tamsulosin monotherapy versus combination therapy with tamsulosin plus tadalafil (2.5 mg vs. 5 mg) on lower urinary tract symptoms (LUTS) severity and patient quality of life in men with benign prostatic hyperplasia (BPH). It also seeks to determine whether the lower tadalafil dose provides adequate symptom relief while minimizing adverse effects over a 12-week follow-up period.
Conditions: Safety
Efficacy
Tamsulosin
Monotherapy
Tadalafil
Lower Urinary Tract Symptoms

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Patients older than 45 years of age.

Clinical diagnosis of benign prostatic hyperplasia (BPH) and moderate to severe lower urinary tract symptoms (LUTS) [International Prostate Symptom Score (IPSS) ≥ 13].

Maximum flow rate (Qmax) ≤ 15 mL/s, prostate volume ≥ 30 mL by transrectal ultrasound.

Exclusion Criteria:

Patients taking α-blockers, beta-blockers, 5-alpha reductase inhibitors, phosphodiesterase-5 (PDE5) inhibitors, anticholinergics, or nitrates were excluded.

Patients with a history of prostate or bladder surgery, lower urinary tract procedures, prostate or bladder cancer, neurological conditions affecting bladder function, severe cardiovascular disease, hepatic impairment, diabetes mellitus with complications, kidney dysfunction (acute or chronic), neurogenic bladder, or congenital urinary anomalies.

Additionally, patients with recent myocardial infarction, unstable angina, severe heart failure, uncontrolled hypertension, Prostate-Specific Antigen (PSA)>4 ng/mL (unless cancer ruled out), active urinary tract infection, urinary retention, and those unavailable for follow-up were also excluded from the study.

Central Contacts: Salah N Salem, MBBCHContact
salahsalem@med.asu.edu.eg00201066047555