NCT07722884 Tamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH
| NCT ID | NCT07722884 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ain Shams University |
| Condition | Safety |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2026-07-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07722884 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Safety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07722884 currently recruiting?
Yes, NCT07722884 is actively recruiting participants. Contact the research team at salahsalem@med.asu.edu.eg for enrollment information.
Where is the NCT07722884 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07722884 clinical trial?
NCT07722884 is sponsored by Ain Shams University. The trial plans to enroll 90 participants.