NCT06491108

Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Vardenafil Versus Tadalafil Versus Tamsulosin in Patients With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Prospective Randomized Study.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: Male
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this prospective randomized controlled study is to compare safety and efficacy of Vardenafil versus Tadalafil versus Tamsulosin in terms of (voiding function, sexual function and quality of life) in the management of moderate BPH related LUTS.

Detailed description

This is prospective randomized controlled study that will be conducted on men with BPH related LUTS amenable to medical treatment at Urology Department, Faculty of Medicine, Tanta University - Egypt after having their written informed consent. The study is planned to include 150 patients in the study period from April 2024 to April 2025. Each enrolled patient must complete 12 weeks on medication with strict scheduled follow up. Inclusion criteria: Sexually active patients with moderate BPH related LUTS amenable to medical treatment and completed 12 weeks follow up period. Exclusion criteria: Indication for combined therapy in patients who have moderate to severe LUTS and an increased risk of disease progression (e.g. prostate volume more than 40 ml) or patients in need for anti-muscarinic for predominant storage symptoms. Indication for surgical intervention: Medically complicated patients: Cardiac patients, unstable angina, recent myocardial infarction (\<3months), hypotension. Concomitant uses (potassium channel openers, alpha 1 blockers, nitrates). Stroke since less than 6 months.

Conditions

• Enlarged Prostate With Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DRUG	Vardenafil 5 Mg Oral Tablet	Comparing safety and efficacy of Vardenafil 5 mg twice oral daily versus established drugs e.g.Tadalafil 5mg and Tamsulosin 0.4 mg once oral daily in terms of (voiding function, sexual function and quality of life) in the management of moderate BPH related LUTS (benign prostatic hyperplasia related lower urinary tract syptoms )

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2024-07-08
• Last updated: 2024-07-08

Locations

1 site across 1 country: Egypt