Tamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH
Recruiting now · Not applicable
Conditions studied: Safety, Efficacy, Tamsulosin, Monotherapy, Tadalafil, Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
In brief
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.
Key facts
- Study ID
- NCT07722884
- Run by
- Ain Shams University
- People needed
- 90
- Starts
- 2026-07-01
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2026-07-23
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Ain Shams University — Cairo, Cairo Governorate, Egypt (enrolling)
Full record on ClinicalTrials.gov
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