Research PROSPECT IV (PROStamol: PErspectives of Combination Therapy) in Patients with Benign Prostatic Hyperplasia

Abstract

The objective: was to determine the efficacy and safety of nine-year therapy in patients with benign prostatic hyperplasia (ВРН) using the combination «Flosin – Prostamol Uno» by the method of assessing the quality of life and the possibility of improving objective data of urological status. The ultimate goal of nine-year follow-up of patients was to reduce the risk of developing acute urinary retention as a complication of this disease.Materials and methods. A study of patients with BPH who were included in PROSPECT IV found that 37 people from the entire cohort at the age of 59–78 years (68.2±4.7) remained under observation for 2020 (of n=94 in PROSPECT III – 39.3 % of patients were followed up for 9 years). In a similar way, the subjects were randomized according to the conditions of previous therapy into two groups: the І group (clinical) included 33 patients who received the combination «Flosin – Prostamol Uno» for 9 years; ІІ group (control) consisted of 4 subjects who received a combination «doxazosin – finasteride» also for 9 years.Results. The obtained results testify to the high therapeutic efficacy of the combination «Flosin – Prostamol Uno», comparable to the combination of drugs «doxazosin and finasteride». Combination therapy with Flosin and Prostamol Uno was well tolerated in patients with a low incidence of adverse events (5.75 %; p <0.05) compared with patients receiving the combination of doxazosin and finasteride (27 %, p <0, 05). 7 (18.9 %) patients were operated on during the last 5 years (TUR – 6; laser vaporization – 1); the level of acute urinary retention – in 7 people in the form of 1–2 episodes, which required operative assistance.Conclusion. The above facts made it possible to assert that: the adherence of patients to the combined conservative therapy of BPH according to the «Flosin – Prostamol Uno» scheme was high (43.2 %); adherence of patients operated on for acute urinary retention to this type of combination therapy was evident (all patients received Extr. Serenoa repens and tamsulosin in the postoperative period); the level of acute urinary retention in persons of group I with BPH who received treatment for 9 years was 19 % (p> 0.05).