Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Benign Prostatic Hyperplasia
Type
Observational
Design
Observational Model: OtherTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 85 years
Gender
Only males

Description

Combination therapy with the 5-? reductase inhibitor, dutasteride, and the ?-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, rand...

Combination therapy with the 5-? reductase inhibitor, dutasteride, and the ?-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.

Tracking Information

NCT #
NCT04831476
Collaborators
Not Provided
Investigators
Not Provided