? Prospective Observational Study for the Evaluation of Disease Control in Patients With Benign PROStatic hyPERplasia Under Fixed Dose comb?naTion Treatment With Dutasteride and Tamsulosin as Well as Their qualitY of Life
Last updated on July 2021Recruitment
- 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