Α Prospective Observational Study for the Evaluation of Disease Control in Patients With Benign PROStatic hyPERplasia Under Fixed Dose combΙnaTion Treatment With Dutasteride and Tamsulosin as Well as Their qualitY of Life
Α Prospective Observational Study for the Evaluation of Disease Control in Patients With Benign PROStatic hyPERplasia Under Fixed Dose combΙnaTion Treatment With Dutasteride and Tamsulosin as Well as Their qualitY of Life
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®)
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.
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.