Administration of Tadalafil in Patients With Benign Prostatic Hyperplasia

Al-Azhar University

Status and phase: Completed; Phase 3

Conditions: BPH With Other Lower Urinary Tract Symptoms

Treatments: Drug: Tadalafil

Study type: Interventional

Funder types: Other

Identifiers

NCT06466369

461

Details and patient eligibility

About

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.

Enrollment: 306 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

306 participants in 3 patient groups

Controlled group

No Intervention group

Low-dose intervention group

Experimental group

Treatment:

Drug: Tadalafil

High-dose intervention group

Experimental group

Treatment:

Drug: Tadalafil