Enlarged Prostate (BPH) Clinical Trials

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Safety and Efficacy of Tamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Ain Shams University
RECRUITING
Cairo
Contact Information
Primary
Salah N Salem, MBBCH
salahsalem@med.asu.edu.eg
00201066047555
Time Frame
Start Date: 2026-07-01
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 90
Treatments
Experimental: Group A
Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 2.5 mg once daily
Experimental: Group B
Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 5 mg once daily
Experimental: Group C
Patients will receive Tamsulosin 0.4 mg once daily (monotherapy)
Related Therapeutic Areas
Sponsors
Leads: Ain Shams University

This content was sourced from clinicaltrials.gov

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