NCT05236634

(Phosphodiesterase 5 Inhibitors & α-blockers): Single Versus Combined Therapy in Benign Prostatic Hyperplasia

Comparative Study Between Fixed Dose Monotherapy (Phosphodiesterase 5 Inhibitors or Alpha Blockers) Versus Combined Therapy in Benign Prostatic Hyperplasia Patients With Lower Urinary Tract Symptoms

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Male
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To compare between efficacy of phosphodiesterase5 inhibitors (tadalafil 5 mg) and Alpha Blockers (tamsulosin 0.4 mg) monotherapy vs combined therapy in treatment of lower urinary tract symptoms of benign prostatic hyperplasia.

Detailed description

The proposed research aims to answer the question about efficacy and safety of phosphodiesterase 5 inhibitors (tadalafil 5 mg) and Alpha Blockers (tamsulosin 0.4 mg) monotherapy vs combined therapy in treatment of lower urinary tract symptoms of benign prostatic hyperplasia . Benign prostatic hyperplasia (BPH) is a disorder histologically characterized as the non-malignant hyperplasia of prostatic cells. Most of patients with BPH present with lower urinary tract symptoms (LUTS). About half of men develop BPH, among those; about half develop some degree of bladder outlet obstruction (BOO). BOO and/or changes in smooth muscle tone and resistance that can accompany BPH may result in (LUTS). Alpha-blockers have been widely used for the treatment of LUTS/BPH for a long time. Some alpha-blockers may cause ejaculatory dysfunction in some individuals. Tadalafil, a (PDE-5), was approved by the Food and Drug Administration (FDA) for the treatment of (ED) in 2003 and for the treatment of BPH in 2011. The PDE5 inhibitors are used in the treatment of ED and there are increasing data of effects of these drugs on bladder and urethral relaxation as well as of prostatic smooth muscles that may relief the symptoms of BPH. Medical treatments for LUTS/BPH are able to significantly impact on sexual function. Sexual side effects like ejaculatory dysfunction, reduced or lost libido, and ED have been widely reported in patients treated with alpha blockers (ABs) and 5-alpha reductase inhibitors, the most utilized drugs for the treatment of LUTS/BPH. The inclusion of Tadalafil in complex of combined conservative therapy of patients with BPH not only improves sexual function but has a positive effect on symptoms of the disease and the psychological state of the patient.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Phosphodiesterase 5 Inhibitors	A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into three groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.
DRUG	Alpha Blockers	A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into three groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.
DRUG	Combined Alpha Blockers and Phosphodiesterase 5 Inhibitors	A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into three groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-05-01
• Completion: 2024-06-30
• First posted: 2022-02-11
• Last updated: 2022-02-11