Efficacy and safety of minimally invasive injection steam therapy for lower urinary tract symptoms caused by benign prostate hyperplasia (first clinical experience in the Russian Federation)

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Abstract

Introduction. Currently, the development of new methods of treatment of benign prostatic hyperplasia (BPH) is continuing, combining the high efficiency of transurethral resection of the prostate, which are safer for elderly patients and provide a high level of quality of life for younger patients. One of these new methods is minimally invasive water vapor thermal therapy.

Aim. To evaluate the efficiency and safety of water vapor thermal therapy in patients with lower urinary tract symptoms (LUTS)/BPH.

Materials and methods. A total of 35 patients with LUTS/BPH who were treated between September 2022 and September 2024 (median follow-up of 12 months) were included in the study. The average age was 68.7±1.5 years. The prostate volume did not exceed 80 cc (52.4±4.2 cc). The Qmax was 9.3±0.7 ml/sec. The postvoid residual volume (PVR) was 73.6±12.2 ml. The overall IPSS score was 26.5±2.3 and QoL was 4.3±0.3. All patients were treated with water vapor thermal therapy according to the standard procedure recommended by the manufacturer (5.7±0.72 injections of water vapor into the prostate). The efficacy was evaluated every 3 months after the procedure. Intra- and postoperative complications were assessed on Clavien-Dindo classification.

Results. After 3 months, 97.1% (34 out of 35) of patients had an improvement in objective urination parameters. Qmax and PVR after 3 months increased up to 17.3±1.5 ml/sec and 20.8±7.2 ml, respectively (p<0.05 compared with baseline values). There was also a significant decrease in IPSS and QoL levels, 8,5±1,3 and 2,3±0,3, respectively (p<0,05 compared with the baseline). Qmax and PVR continued to improve till the 6 months of follow-up (17.6±1.1ml/sec and 14.3±0.8 ml, respectively, p<0.05 compared with baseline and after 3 months). There was also a significant decrease in IPSS and QoL to 4.1±1.3 and 1.4±0.1 points, respectively (p<0.05 compared to 3 months). After that, these values remained stable throughout the follow-up period. The overall efficiency of the treatment (at median follow-up of 12 months) was 88,6%. Perioperative complications occurred in 9 out of 35 patients (did not exceed IIIa according to Clavien-Dindo).

Conclusions. Minimally invasive water vapor thermal therapy is a new effective and safe method of treating patients with LUTS/BPH. After the procedure, there is a significant improvement in lower urinary tract symptoms.

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About the authors

Andrey N. Shibaev

Tver State Medical University; Tver State Medical University; University Clinic of Tver State Medical University; GBUZ Moscow district “Moscow Regional Research Clinical Institute named after M.F. Vladimirsky

Email: anshibaev@rambler.ru
ORCID iD: 0000-0002-5568-3342

Ph.D., Head of the Department of Urology and Andrology of FGBOU VO Tver State Medical University of the Ministry of Health of Russia; University Clinic of Tver State Medical University; Leading researcher at the Department of Urology of GBUZ Moscow district “Moscow Regional Research Clinical Institute named after M.F. Vladimirsky

Russian Federation, 170100, Tver, Sovetskaya st., 4; 170100, Tver, Sovetskaya st., 4; 129110, Moscow, st. Shchepkina, 61/2

Alexey A. Podoynitsyn

RTH Clinic; GBUZ Moscow district “Moscow Regional Research Clinical Institute named after M.F. Vladimirsky

Email: a4955145801@gmail.com
ORCID iD: 0000-0001-9739-6248

Ph.D., MD, Head of the Department of Urology of GBUZ Moscow district “Moscow Regional Research Clinical Institute named after M.F. Vladimirsky

Russian Federation, Moscow; 129110, Moscow, st. Shchepkina, 61/2

Ruslan S. Suleymanov

Tver State Medical University

Email: rusuromed@gmail.com
ORCID iD: 0000-0002-0534-0472

urologist at the University Clinic 

Russian Federation, 170100, Tver, Sovetskaya st., 4

Yulia V. Pavlova

GBUZ Moscow district “Moscow Regional Research Clinical Institute named after M.F. Vladimirsky

Email: 9250659260@mail.ru
ORCID iD: 0000-0002-3042-8708

Ph.D., researcher at the Department of Urology 

Russian Federation, 129110, Moscow, st. Shchepkina, 61/2

Dmitry V. Bogatov

Tver State Medical University

Email: bogatov.d@yandex.ru

Ph.D., associate professor at the Department of Urology and Andrology of FGBOU VO Tver State Medical University of the Ministry of Health of Russia; University Clinic of Tver State Medical University

Russian Federation, 170100, Tver, Sovetskaya st., 4

Denis V. Federyakin

Tver State Medical University

Email: denic_federiakin@mail.ru

Ph.D., MD, professor, Chief of the University Clinic 

Russian Federation, 170100, Tver, Sovetskaya st., 4

Evgeniy V. Ivkin

S.P. Botkin’s State Clinical Hospital

Email: e.ivkin@hotmail.com
ORCID iD: 0000-0003-4568-9561

Ph.D., urologist, oncologist, Moscow Urologic Center

Russian Federation, 125284, Moscow, 2nd Botkinsky proezd, 5

Anna T. Kozlova

S.P. Botkin’s State Clinical Hospital

Author for correspondence.
Email: k.a.timofeevna@mail.ru

urologist, Moscow Urologic Center

Russian Federation, 125284, Moscow, 2nd Botkinsky proezd, 5

Konstantin B. Kolontarev

S.P. Botkin’s State Clinical Hospital; FGBOU VO “Russian University of Medicine”, Ministry of Health of the Russian Federation

Email: kb80@yandex.ru
ORCID iD: 0000-0003-4511-5998

Deputy Chief of the Moscow Urological Center of S.P. Botkin City Clinical Hospital; Ph.D., MD, professor at the Department of Urology of Scientific and Educational Institute of the Clinical Medicine named after N.A. Semashko; FGBOU VO “Russian University of Medicine”

Russian Federation, 125284, Moscow, 2nd Botkinsky proezd, 5; Moscow

Alexander V. Govorov

S.P. Botkin’s State Clinical Hospital; FGBOU VO “Russian University of Medicine”, Ministry of Health of the Russian Federation

Email: dr.govorov@gmail.com
ORCID iD: 0000-0003-3299-0574

urologist at the Moscow Urological Center of S.P. Botkin City Clinical Hospital; Ph.D., MD, professor of the RAS, professor at the Department of Urology of Scientific and Educational Institute of the Clinical Medicine named after N.A. Semashko; FGBOU VO “Russian University of Medicine”

Russian Federation, 125284, Moscow, 2nd Botkinsky proezd, 5; Moscow

Dmitry Yu. Pushkar

S.P. Botkin’s State Clinical Hospital; FGBOU VO “Russian University of Medicine”, Ministry of Health of the Russian Federation

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

academician of RAS, Ph.D., MD, Professor, Chief urologist of the Ministry of Health of Russia, Chief urologist of the Moscow Health Department, Chief of Moscow Urological Center of S.P. Botkin City Clinical Hospital, Head of the Department of Urology of FGBOU VO “Russian University of Medicine”

Russian Federation, 125284, Moscow, 2nd Botkinsky proezd, 5; Moscow

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Supplementary files

Supplementary Files
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2. Fig. 1. Injection needle

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3. Fig. 2. Introduction of steam into prostate tissue (under visual control)

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4. Fig. 3. Objective effectiveness of treatment: dynamics of maximum urine flow rate (Qmax) and residual urine volume (PVR). Median follow-up is 12 months.

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5. Fig. 4. Subjective effectiveness of treatment: dynamics of lower urinary tract symptoms (IPSS scores) and patients’ quality of life (QoL). Median follow-up 12 months

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6. Fig. 5. Relapse-free course of LUTS/BPH after Rezum® injection-steam therapy (median follow-up 12 months, n=35)

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7. Fig. 6. Histological changes in prostate tissue after exposure to steam (after 3 months) during injection-steam therapy. Atrophy of glandular tissue of the prostate and fibrosis of the stroma. Hemotoxylin and Eosin, x60

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