Α Prospective Observational Study for the Evaluation of Disease Control and Quality of Life in Patients With Benign PROStatic hyPERplasia Under Fixed Dose combΙnaTion Treatment With Dutasteride and Tamsulosin . PROSPERITY Group of Studies (I&II)

ELPEN

Status: Completed

Conditions: Benign Prostatic Hyperplasia

Treatments: Other: Patients with Benign Prostate Hyperplasia

Study type: Observational

Funder types: Industry

Identifiers

NCT04831476

2020-DTM-EL-126/133

Details and patient eligibility

About

Investigation of the efficacy and safety of the stable combination of dutasteride and tamsulosin (Dinaplex®) in the Greek population as well as the evaluation of the quality of life of patients with benign prostatic hyperplasia (BPH) in treatment with a stable combination of dutasteride and tamsulosin (Dinaplex®)

Full description

Combination therapy with the 5-α reductase inhibitor, dutasteride, and the α-blocker, tamsulosin, in men with moderate to severe benign prostatic hyperplasia and prostate enlargement, was studied in the Combination of Avodart ™ and Tamsulosin (CombAT) which was a four-year, global, multicenter, randomized, double-blind, parallel design (3 arms) study. The aim of the study was to investigate the benefits of combination therapy (dutasteride-tamsulosin) compared to monotherapy in terms of improvement of symptoms and long-term results (AUR and surgery), in men with moderate to severe BPH. The primary endpoint in the two years since the start of the study was the change in the IPSS score, while the primary endpoint, after four years of treatment, was the time until the long-term results manifested (i.e. AUR or CF surgery) as well as the percentage of participants who were led to them. Patients were at least 50 years old with a prostate tumor ≥30 cm3 and a PSA level ≥ 1.5 ng / mL. 4838 men (39) participated in this study.

Enrollment: 1,296 patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult male patient with moderate to severe BPH symptoms receiving either monotherapy, dual medication as monoproducts or other stable combination and not responding adequately to treatment.
• Adult male patient with BPH who has fully understood the study procedures and has signed a consent form after information.

Exclusion criteria

• Patient who does not meet the criteria for taking the study drug (s), according to the Summary of Product Characteristics of each drug in the study.