Administration of Tadalafil in Patients With Benign Prostatic Hyperplasia

Phase 3

Completed

• Conditions: BPH With Other Lower Urinary Tract Symptoms
• Interventions: Drug: Tadalafil

• Registration Number: NCT06466369
• Lead Sponsor: Al-Azhar University

Brief Summary

The aim of the present study is to evaluate the efficacy and safety of once daily administration PDE5 inhibitors, tadalafil for 3 months as anti-inflammatory, antiproliferative and relaxant effects in ED with BPH patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-15
• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-14
• Study First Posted: 2024-06-20
• Primary Completion: 2024-07-01
• Status Verified: 2024-08
• Study Completion: 2024-08-01
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 306

Inclusion Criteria

• Aged ≥ 45 years and sexually active with symptomatic benign prostatic hyperplasia (no hospitalization 3 months prior to start of treatment).

Exclusion Criteria

• 1. Patients with bladder or prostate malignancy. 2. A history of lower urinary tract surgery. 3. History of catheterization. 4. Urinary retention. 5. Urinary tract infection. 6. Stone disease. 7. Any neurological disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dose intervention group	Tadalafil	-
High-dose intervention group	Tadalafil	-

Primary Outcome Measures

Name	Time	Method
Evaluation of International prostate symptom score (IPSS)/quality of life (QoL).	3 months compared to baseline
Evaluation of International index of erectile function (IIEF).	3 months compared to baseline

Trial Locations

Locations (1)

outpatient clinic of the urology department at AlZahraa University Hospital, Al-Azhar University, Faculty of Medicine for Girls.; 🇪🇬 Cairo, Egypt