Possibilities of using Urorek® (silodosin, 8 mg) for empirical therapy in patients with lower urinary tract symptoms due to benign prostatic hyperplasia: results of the Russian multicenter observational study MERCURY

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Aim. To evaluate the efficiency, safety, and tolerability of Urorek® (silodosin, 8 mg) in empirical therapy of lower urinary tract symptoms (LUTS) in patients with benign prostatic hyperplasia (BPH) without prior diagnostic assessment.

Materials and Methods. An open, prospective, multicenter observational study (MERCURY) was carried out in five clinical centers in Russia with the participation of 123 men (114 completed per protocol), aged 50–83 years. Urorek was prescribed empirically to patients with moderate LUTS. Efficacy was assessed using IPSS, QoL, VPSS scores, uroflowmetry parameters (Qmax, Qave), International Index of Erectile Function (IIEF), and hemodynamic parameters. The treatment duration was 90 days.

Results. At day 15, a significant IPSS decrease of 3.77 points was observed; at 1 and 3 months the reduction was 5.63 and 6.86 points, respectively (p < 0.001). QoL, VPSS, Qmax, and Qave improved significantly at all stages. By day 15, Qmax increased by 2.49 ml/s, and by day 91 by 4.74 ml/s (35.5% increase). Adverse events occurred in 1.72% (retrograde ejaculation); no cases of orthostatic hypotension or arrhythmia were recorded. The drug had no significant effect on blood pressure or heart rate.

Discussion. Silodosin demonstrated a rapid and marked effect on both voiding and storage symptoms of BPH, improving quality of life. Efficiency was evident as early as 15 days. VPSS showed strong correlation with IPSS and can be used in elderly or cognitively impaired patients. The drug demonstrated a high safety profile, especially in comorbid patients, and can be prescribed under conditions of limited diagnostic resources.

Conclusion. Urorek® (silodosin, 8 mg) is effective and safe for empirical treatment of LUTS in BPH patients, including elderly and comorbid individuals. Its high selectivity for α1A-adrenergic receptors, low risk of drug-drug interactions, and lack of cardiovascular effects make it a treatment of choice for patients with LUTS/BPH prior to completion of the full diagnostic work-up.

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Sobre autores

Dmitry Pushkar

Russian University of Medicine; Botkin Moscow Multidisciplinary Clinical and Research Center

Email: pushkardm@mail.ru
ORCID ID: 0000-0002-6096-5723

Dr. Sc. (Med.), Professor, Academician of the Russian Academy of Sciences, Head of the Urology Department; Chief of the Moscow Urological Center, Chief Urologist of the Ministry of Health of Russia, Chief Urologist of the Moscow Health Department

Rússia, 4, Dolgorukovskaya St., Moscow, 127006; 5, 2nd Botkinsky Dr., Moscow, 125284

Alexander Bernikov

Russian University of Medicine; Botkin Moscow Multidisciplinary Clinical and Research Center

Autor responsável pela correspondência
Email: bernikov@mac.com
ORCID ID: 0000-0001-8361-585X

Cand. Sc. (Med.), Associate Professor at the Urology Department; Urologist, Oncologist at the Moscow Urological Center

Rússia, 4, Dolgorukovskaya St., Moscow, 127006; 5, 2nd Botkinsky Dr., Moscow, 125284

Andrey Shvedov

Botkin Moscow Multidisciplinary Clinical and Research Center

Email: dr.shvedov135@mail.ru
ORCID ID: 0000-0003-3127-9270

Urologist at Urology Department No. 41 of the Moscow Urological Center

Rússia, 5, 2nd Botkinsky Dr., Moscow, 125284

Alexander Zyryanov

Ural State Medical University; Sverdlovsk Regional Clinical Hospital No. 1

Email: zav1965@mail.ru
ORCID ID: 0000-0001-8105-7233

Dr. Sc. (Med.), Professor, Head of the Urology, Nephrology and Transplantology Department; Head of the Regional Urology Center

Rússia, 3, Repin St., Yekaterinburg, 620028; 185, Volgogradskaya St., Yekaterinburg, 620102

Igor Feofilov

Novosibirsk State Medical University

Email: fil_urolog@mail.ru
ORCID ID: 0000-0001-8938-2479

Dr. Sc. (Med.), Associate Professor, Head of the Urology Department, Chief Urologist of the Ministry of Health of Novosibirsk Region, Chairman of the Novosibirsk Branch of the Russian Urological Society, Honored Doctor of the Russian Federation

Rússia, 52, Krasny Ave., Novosibirsk, 630091

Andrey Igoshkin

Novosibirsk State Medical University; Novosibirsk Regional Clinical Hospital

Email: dr.igoshkin@mail.ru
ORCID ID: 0009-0002-3665-1027

Urologist; Assistant at the Urology Department

Rússia, 52, Krasny Ave., Novosibirsk, 630091; 130, Nemirovich-Danchenko St., Novosibirsk, 630087

Vladimir Medvedev

Kuban State Medical University; Professor Ochapovsky Regional Clinical Hospital No. 1

Email: medvedev_vl@mail.ru
ORCID ID: 0000-0001-8335-2578

Dr. Sc. (Med.), Professor, Head of the Urology Department; Deputy Chief Physician for Urology

Rússia, 4, Sedin St., Krasnodar, 350063; 167, May 1 St., Krasnodar, 350086

Mikhail Efremov

Kuban State Medical University; Professor Ochapovsky Regional Clinical Hospital No. 1

Email: efremov.uro@yandex.ru
ORCID ID: 0000-0003-2733-0619

Cand. Sc. (Med.), Assistant at the Department of Urology; Urologist

Rússia, 4, Sedin St., Krasnodar, 350063; 167, May 1 St., Krasnodar, 350086

Boris Komyakov

Mechnikov North-Western State Medical University; City Multidisciplinary Hospital No. 2

Email: komyakovbk@mail.ru
ORCID ID: 0000-0002-8606-9791

Dr. Sc. (Med.), Professor, Head of the Department of Urology; Head of the Department and Director of the Scientific and Practical Urology Center

Rússia, 41, Kirochnaya St., Saint Petersburg, 191015; 5, Uchebny Lane, Saint Petersburg, 194354

Vladimir Fadeev

Mechnikov North-Western State Medical University

Email: fad_ur_75@mail.ru
ORCID ID: 0009-0005-0509-037X

Professor at the Department of Urology

Rússia, 41, Kirochnaya St., Saint Petersburg, 191015

Bibliografia

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2. Fig. 1. Research design

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3. Fig. 2. Visual Prostate Symptom Score (VPSS)

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4. Fig. 3. Dynamics of the total IPSS score

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5. Fig. 4. Dynamics of quality of life score on the QoL scale

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6. Fig. 5. Qmax dynamics

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7. Fig. 6. Dynamics of average urinary flow rate (Qave)

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8. Fig. 7. Dynamics of the score on the visual scale (VPSS)

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9. Fig. 8. Dynamics of cardiovascular system indicators. A – systolic blood pressure (SBP) indicators, B – diastolic blood pressure (DBP) indicators, C – heart rate (HR) indicators

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