Efficiency and safety of using a urethral catheter with ultrasound-induced drug coating with methylprednisolone for programmed balloon dilation for the prevention of recurrence of bladder neck sclerosis in patients after endoscopic prostatic procedures

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Abstract

Introduction. One of the most promising minimally invasive methods for preventing the recurrence bladder neck sclerosis (BNS) is balloon dilatation of the bladder neck under transrectal ultrasound control using a urethral catheter with an ultrasound-induced drug coating with methylprednisolone.

Aim. To evaluate the efficiency and safety of serial balloon dilatation of the bladder neck under transrectal ultrasound control using a urethral catheter with an ultrasound-induced drug coating with methylprednisolone for the prevention of recurrence BNS after endoscopic procedures on the prostate.

Materials and methods. The study involved 30 patients with recurrent BNS who were included in the protocol of serial balloon dilation of the bladder neck. Recurrence of BNS was confirmed in each case by the flexible urethroscopy in the outpatient settings, after which the patient was included in the protocol of serial balloon dilation of the bladder neck. Incision of the bladder neck was performed using a thulium Fiber laser U3 (IRE-Polus) with power settings of 1 J, 30 Hz, 30 W or bipolar energy with the PlasmaNeedle electrode (Olympus). Serial balloon dilation was performed three weeks after repeated incision of the bladder neck. Before each session of balloon dilation, the following parameters were assessed in all patients: the total International Prostate Symptom Score (IPSS) and quality of life (QoL) score, Qmax and postvoid residual.

Results. Contracture stabilization at a urodynamically acceptable level (Qmax is higher than 12 ml/s and QoL is less than 3) was observed in 73.3% (n=22) of patients with a median follow-up of 10 months. Effective treatment required a median of 6 sessions of balloon dilatation. 4 out of 8 patients with recurrent BNS refused further participation in the study, while the remaining 4 underwent re-incision of the bladder neck followed by inclusion in the repeat balloon dilatation program, which was successful, thereby increasing the primary efficiency to 86.7%. Based on the Kaplan-Meier survival analysis, it was found that the longer the time since the start of serial balloon dilation, the lower the chance of recurrence of BNS. In terms of safety, no patient experienced complications associated with serial balloon dilation.

Conclusion. Serial balloon dilatation of the bladder neck under transrectal ultrasound control using a urethral catheter with an ultrasound-induced drug coating with methylprednisolone is an effective and safe technique that can be offered to patients to prevent recurrent BNS.

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About the authors

A. A. Kamalov

Moscow State University by Lomonosov; Medical Scientific and Educational Center of Lomonosov Moscow State University

Email: armais.kamalov@rambler.ru
ORCID iD: 0000-0003-4251-7545

Professor, Ph.D., MD, Academician of the RAS, Director of the "University Hospital" and Head of the Department of Urology and Andrology

Russian Federation, Moscow; Moscow

N. I. Sorokin

Moscow State University by Lomonosov; Medical Scientific and Educational Center of Lomonosov Moscow State University

Email: nisorokin@mail.ru
ORCID iD: 0000-0001-9466-7567

Ph.D., MD, professor at the Department of Urology and Andrology, Faculty of Fundamental Medicine

Russian Federation, Moscow; Moscow

A. V. Kadrev

Medical Scientific and Educational Center of Lomonosov Moscow State University

Email: akadrev@yandex.ru
ORCID iD: 0000-0002-6375-8164

Ph.D., Head of the Department of Ultrasound Diagnostics, researcher at the Department of Urology and Andrology of Medical Scientific and Educational Center, assistant at the Department of Ultrasound Diagnostics

Russian Federation, Moscow

R. M. Gorbunov

Medical Scientific and Educational Center of Lomonosov Moscow State University

Email: gorbunov.roman82@gmail.com
ORCID iD: 0000-0001-8122-1275

Doctor of ultrasound diagnostics, Department of Ultrasound Diagnostics of Medical Scientific and Educational Center

Russian Federation, Moscow

A. P. Mikhalchenko

Medical Scientific and Educational Center of Lomonosov Moscow State University

Email: alexandr.mixal4encko@yandex.ru
ORCID iD: 0009-0007-6016-3417

Doctor of ultrasound diagnostics, Department of Ultrasound Diagnostics of Medical Scientific and Educational Center

Russian Federation, Moscow

S. G. Koknaev

GBUZ Chelyabinsk Regional Clinical Hospital

Email: koknaev74@mail.ru
ORCID iD: 0009-0009-6352-3806

urologist, Head of the Department of GBUZ Chelyabinsk Regional Clinical Hospital, Chief Urologist of the Ministry of Health of Chelyabinsk region

Russian Federation, Chelyabinsk

O. Yu. Nesterova

Moscow State University by Lomonosov; Medical Scientific and Educational Center of Lomonosov Moscow State University

Email: oy.nesterova@gmail.com
ORCID iD: 0000-0003-3355-4547

Ph.D., urologist at the Medical Scientific and Educational Center, researcher at the Department of Urology and Andrology of Medical Scientific and Educational Center, senior tutor of the Department of Urology and Andrology of Faculty of Fundamental Medicine

Russian Federation, Moscow; Moscow

A. A. Strigunov

Moscow State University by Lomonosov; Medical Scientific and Educational Center of Lomonosov Moscow State University

Email: an-strigunov@yandex.ru
ORCID iD: 0000-0003-4518-634X

Ph.D., urologist at the Medical Scientific and Educational Center, trainee researcher at the Department of Urology and Andrology of Medical Scientific and Educational Center

Russian Federation, Moscow; Moscow

B. M. Shaparov

Moscow State University by Lomonosov; GBUZ City Clinical Hospital No. 31 named after academician G.M. Savelieva of Moscow Healthcare Department

Author for correspondence.
Email: uroboris@mail.ru
ORCID iD: 0000-0002-0232-1567

Ph.D., urologist at the Department of Urology and Andrology, Medical Scientific and Educational Center

Russian Federation, Moscow; Moscow

D. A. Tsigura

Moscow State University by Lomonosov; Medical Scientific and Educational Center of Lomonosov Moscow State University

Email: darya.cigura@gmail.com
ORCID iD: 0000-0002-0512-3152

Ph.D. student at the Department of Urology and Andrology, Medical Scientific and Educational Center

Russian Federation, Moscow; Moscow

O. A. Osmanov

Moscow State University by Lomonosov; GBUZ City Clinical Hospital No. 31 named after academician G.M. Savelieva of Moscow Healthcare Department

Email: omar_osmanov07@mail.ru
ORCID iD: 0000-0003-1453-9771

urologist at the Department of Urology and Andrology, Medical Scientific and Educational Center

Russian Federation, Moscow; Moscow

A. A. Kritsky

LLC Magnetic Drug Delivery, AMT & C Group

Email: kritskiy@amtc.org
ORCID iD: 0000-0001-8087-0302

Executive Director

Russian Federation, Moscow

O. A. Sindeeva

Center for Neurobiology and Brain Rehabilitation named after Vladimir Zelman, Skolkovo Institute of Science and Technology

Email: o.sindeeva@skoltech.ru
ORCID iD: 0000-0002-5288-4157

Ph.D. in Biology, researcher

Russian Federation, Moscow

A. S. Abdurashitov

Center for Neurobiology and Brain Rehabilitation named after Vladimir Zelman, Skolkovo Institute of Science and Technology

Email: a.abdurashitov@skoltech.ru
ORCID iD: 0000-0003-0731-8364

Ph.D. in Physical and Mathematical Science, researcher

Russian Federation, Moscow

P. I. Proshin

Center for Neurobiology and Brain Rehabilitation named after Vladimir Zelman, Skolkovo Institute of Science and Technology

Email: pavel.proshin@skoltech.ru
ORCID iD: 0000-0002-6056-3265

Ph.D. student

Russian Federation, Moscow

N. A. Pyataev

National Research Ogarev Mordovia State University named after N.P. Ogarev

Email: pyataevna@mail.ru

Ph.D., MD, professor

Russian Federation, Saransk

G. B. Sukhorukov

Center for Neurobiology and Brain Rehabilitation named after Vladimir Zelman, Skolkovo Institute of Science and Technology

Email: g.sukhorukov@skoltech.ru
ORCID iD: 0000-0001-6213-0562

Ph.D. in Physical and Mathematical Science, professor

Russian Federation, Moscow

References

  1. Yan P., Cui Y., Huang Y., et al. Intraoperative and postoperative outcomes of thulium laser enucleation versus bipolar resection in the transurethral treatment of benign prostatic hyperplasia: a meta-analysis. Lasers in medical science. England. 2022;37(5):2517–2525.
  2. Primiceri G., Castellan P., Marchioni M., et al. Bladder Neck Contracture After Endoscopic Surgery for Benign Prostatic Obstruction: Incidence, Treatment, and Outcomes. Current urology reports. United States. 2017;18(10):79.
  3. Abbosov S.A., Sorokin N.I., Kadrev A.V., et al. Predictors of the development of sclerosis of the bladder neck after transurethral interventions on the prostate gland. Urology. 2021;5:73–77. Russian (Аббосов Ш.А., Сорокин Н.И., Кадрев А.В., et al. Предикторы развития склероза шейки мочевого пузыря после трансуретральных вмешательств на предстательной железе. Урология. 2021;5:73–77).
  4. EAU Guidelines. Edn. presented at the EAU Annual Congress Milan, Italy 2023. ISBN 978-94-92671-19-6.
  5. Mann J.A., Silverman J., Westenberg A. Intralesional steroid injection combined with bladder neck incision is efficacious in the treatment of recurrent bladder neck contracture. // Lower urinary tract symptoms. Australia. 2021;13(1):64–68.
  6. Ramirez D., Simhan J., Hudak S.J., et al. Standardized approach for the treatment of refractory bladder neck contractures. The Urologic clinics of North America. United States. 2013;40(3):371–380.
  7. Abbosov S.A., Sorokin N.I., Kadrev A.V. and others. Sclerosis of the bladder neck: alternative treatment methods and prospects for their development. Experimental and clinical urology. 2021;3:94–10ю Russian (Аббосов Ш.А., Сорокин Н.И., Кадрев А.В. и др. Склероз шейки мочевого пузыря: альтернативные методы лечения и перспективы их развития. Экспериментальная и клиническая урология. 2021;3:94–100).
  8. Wu M.-H., Liu J.-X., Zhang Y.-F., et al. Bladder neck contracture following transurethral surgery of prostate: a retrospective single-center study. World journal of urology. Germany. 2024;42(1):14.
  9. Zhang L., Liu S., Wu K., et al. Management of highly recurrent bladder neck contractures via transurethral resection combined with intra- and post-operative triamcinolone acetonide injections. World journal of urology. Germany. 2021;39(2):527–532.
  10. Kamalov A.A., Sorokin N.I., Kadrev A.V. et al.. A method for preventing scarring of the bladder neck after endoscopic removal of prostate hyperplasia: pat. RU 2803575 C1 USA. 2023. Russian (Камалов А.А., Сорокин Н.И., Кадрев А.В. и др. Способ профилактики рубцовой деформации шейки мочевого пузыря после эндоскопического удаления гиперплазии простаты: pat. RU 2803575 C1 USA. 2023).
  11. Sindeeva O.A., Abdurashitov A.S., Proshin P.I., et al. Ultrasound-Triggerable Coatings for Foley Catheter Balloons for Local Release of Anti-Inflammatory Drugs during Bladder Neck Dilation. Pharmaceutics. Switzerland. 2022;14(10).
  12. Kamalov A.A., Sorokin N.I., Kadrev A.V. et al. The use of a urethral catheter with an ultrasound-induced biopolymer drug coating in the prevention of recurrent scarring of the bladder neck in patients after endoscopic removal of prostate hyperplasia. Urologiia. 2023;6:145–150. Russian (Камалов А.А., Сорокин Н.И., Кадрев А.В. и др. Применение уретрального катетера с УЗ-индуцируемым биополимерным лекарственным покрытием в профилактике рецидивирующей рубцовой деформации шейки мочевого пузыря у пациентов после эндоскопического удаления гиперплазии простаты. Урология. 2023;6:145–150).
  13. Rosenbaum C.M., Vetterlein M.W., Fisch M., et al. Contemporary Outcomes after Transurethral Procedures for Bladder Neck Contracture Following Endoscopic Treatment of Benign Prostatic Hyperplasia. Journal of clinical medicine. Switzerland. 2021;10(13).
  14. Nealon S.W., Bhanvadia R.R., Badkhshan S., et al. Transurethral Incisions for Bladder Neck Contracture: Comparable Results without Intralesional Injections. Journal of clinical medicine. Switzerland. 2022;11(15).
  15. Ramchandani P., Banner M.P., Berlin J.W., et al. Vesicourethral anastomotic strictures after radical prostatectomy: efficacy of transurethral balloon dilation. Radiology. United States. 1994;193(2):345–349.
  16. Furr J., Gelman J. Endoscopic Management of Urethral Stricture Disease and Bladder Neck Contractures. Journal of endourology. United States. 2020;34(S1):S7–S12.
  17. Eltahawy E., Gur U., Virasoro R., et al. Management of recurrent anastomotic stenosis following radical prostatectomy using holmium laser and steroid injection. BJU international. England. 2008;102(7):796–798.
  18. Sourial M.W., Richard P.O., Bettez M., et al. Mitomycin-C and urethral dilatation: A safe, effective, and minimally invasive procedure for recurrent vesicourethral anastomotic stenoses. Urologic oncology. United States. 2017;35(12):672.e15-672.e19.
  19. Park R., Martin S., Goldberg J.D., et al. Anastomotic strictures following radical prostatectomy: insights into incidence, effectiveness of intervention, effect on continence, and factors predisposing to occurrence. Urology. United States. 2001;57(4):742–746.
  20. Roman L.I., Iaker E.L. Transurethral prostatodilation (Deisting’s technic) as a conservative method of surgical treatment of aged and weakened patients with adenoma and associated prostatic atrophy and contracture of the neck of the urinary bladder. Urologiia i nefrologiia. Russia 1969;34(2):32–35.
  21. Kamalov A.A., Sorokin N.I., Kadrev A.V. and others. A method for preventing scarring of the bladder neck after endoscopic removal of prostate hyperplasia: pat. #2725549 USA. 2020. Russian (Камалов А.А., Сорокин Н.И., Кадрев А.В. и др. Способ профилактики рубцовой деформации шейки мочевого пузыря после эндоскопического удаления гиперплазии простаты: pat. #2725549 USA. 2020).
  22. Abbosov S.A., Sorokin N.I., Shomarufov A.B., et al. Assessment of the Balloon Dilation Efficiency in Bladder Neck Contracture after Transurethral Interventions on the Prostate. Urological Science. 2022;33(3):130–135.
  23. Gai M., Frueh J., Tao T., et al. Polylactic acid nano- and microchamber arrays for encapsulation of small hydrophilic molecules featuring drug release via high intensity focused ultrasound. Nanoscale. England. 2017;9(21):7063–7070.
  24. Sindeeva O.A., Prikhozhdenko E.S., Schurov I., et al. Patterned Drug-Eluting Coatings for Tracheal Stents Based on PLA, PLGA, and PCL for the Granulation Formation Reduction: In Vivo Studies. Pharmaceutics. Switzerland. 2021;13(9).
  25. Shaw N.M., Marhamati S., Friedman A., et al. Recurrent vesicourethral anastomotic stenosis following treatment for prostate cancer: an effective endoscopic treatment using bipolar plasma button and triamcinolone. International Urology and Nephrology. Springer Netherlands. 2022;54(5):1001–1008.

Supplementary files

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2. Fig. 1. General scheme of the study design

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3. Fig. 2. Modification of urethral catheters using a polymer film made of polylactic acid A — diagram of the structure of a microcontainer containing a medicinal substance; B — microcontainers after saturation with a medicinal substance; C, D — electron micrographs of the film surface; D — urethral catheter with an applied coating.

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4. Fig. 3. Balloon dilation of the cicatricially deformed bladder neck under transrectal ultrasound control using a urethral catheter with ultrasound-induced drug coating with methylprednisolone A — transrectal ultrasound visualization of the bladder neck and the urethral catheter balloon during the procedure; B — schematic representation of the process of balloon dilation of the bladder neck using a urethral catheter with ultrasound-induced polymer drug coating.

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5. Fig. 4. Dynamics of the assessed parameters in the group of patients under study. Dynamics of IPSS (A), QoL (B), Qmax (C) and OOM (D) starting from the measurement to repeated incision (point 0 on the X scale) with subsequent assessment of the dynamics before each session of balloon dilation (points from 1 to 10 on the X scale).

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6. Fig. 5. Kaplan-Meier curves showing the probability of recurrence of RDSC after the start of balloon dilation sessions (gray borders indicate 95% CI)

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