Tamsulosin alone vs. tamsulosin with tadalafil for troublesome urinary symptoms from enlarged prostate

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares tamsulosin monotherapy to a combination of tamsulosin with tadalafil in men with benign prostatic hyperplasia and moderate-to-severe LUTS. Participants are assigned to either tamsulosin alone, or tamsulosin plus tadalafil at 2.5 mg or 5 mg, to observe effects on LUTS severity and quality of life over a 12-week period. The goal is to determine if a lower tadalafil dose provides meaningful symptom relief with fewer adverse effects. Eligibility includes men over 45 with IPSS ≥13, Qmax ≤15 mL/s, and prostate volume ≥30 mL, while excluding those on other uroactive or cardiovascular medications or with significant comorbidities. The trial is sponsored by Ain Shams University in Cairo, with no listed collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ain Shams University
  Cairo, Cairo Governorate, Egypt Recruiting

Study contacts

• Study coordinator: Salah N Salem, MBBCH
• Email: salahsalem@med.asu.edu.eg
• Phone: 00201066047555

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.