MISTER Study: Minimally Invasive Steam Therapy - Russian Effectiveness Registry

Обзор

Rezūm is a minimally invasive procedure that uses water vapor (steam) to treat urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia, BPH). It has been used in clinical practice since receiving FDA approval in 2015 and is recommended as a treatment option for men with moderate-to-severe urinary symptoms, including those who wish to preserve ejaculatory function. Clinical trials have shown that Rezūm improves urinary symptoms and flow rates, with benefits that last for at least five years, a low reoperation rate, and a low risk of sexual side effects. Despite this evidence, several important questions remain. It is not well understood which patients are more likely to experience temporary urinary retention after the procedure, need repeat treatment, or develop ejaculatory changes. Standardized criteria for defining overall treatment success are also lacking. The MISTER study is a multicenter registry designed to evaluate real-world outcomes of Rezūm therapy in patients treated in the Russian Federation. Using data from a large patient cohort, the study aims to identify factors associated with urinary retention after catheter removal, the need for repeat treatment or return to medication, and changes in ejaculatory function. The study will also develop and test combined criteria for defining treatment success.

Вмешательства

• Процедура Rezūm
  Rezūm therapy is performed transurethrally by specialists at the study centers in accordance with established clinical practice. The type of anesthesia, the number and location of water vapor injections, treatment of the median lobe, characteristics of the indwelling catheter, and duration of catheterization were determined by the attending physician.

Первичные конечные точки

• Rate of Rezūm therapy failure [Срок оценки: 12 months]

Вторичные конечные точки (7)

• Post-void residual urine volume [Срок оценки: 14 days]
• International Prostate Symptom Score (IPSS) [Срок оценки: 3, 6, and 12 months]
• Qmax [Срок оценки: 3, 6, and 12 months]
• Prostate volume [Срок оценки: 3, 6, and 12 months]
• PSA level [Срок оценки: 3, 6, and 12 months]
• International Index of Erectile Function (IIEF-5) [Срок оценки: 3, 6, and 12 months]
• Rate of de novo retrograde ejaculation [Срок оценки: 3, 6, and 12 months]

Критерии участия

Критерии включения

• Lower urinary tract symptoms (IPSS ≥8 points; QoL ≥3 points) due to BPH
• Prostate volume of 30-150 cm³
• Qmax ≤15 mL/s; post-void residual urine volume <300 mL

Non-Inclusion Criteria

• Prostate cancer
• Acute infections of the urinary tract, prostate, or scrotal organs
• Neurogenic lower urinary tract dysfunction
• Bladder stone(s)
• Urethral stricture
• Prior prostate surgery

Критерии исключения

• Patient refusal to allow use of medical data for scientific analysis
• Missing or lost data required for analysis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Россия · 1 центр

• Institute for Urology and Reproductive Health, Sechenov University — Moscow

Публикации

• 1. Sandhu J. S., Bixler B. R., Dahm P. et al. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (BPH): AUA Guideline Amendment 2023 // The Journal of Urology. - 2024. - Vol. 211, № 1. - P. 11-19. - DOI: 10.1097/JU.0000000000003698. 2. Dixon C. M., Rijo Cedano E., Mynderse L. A., Larson T. R. Transurethral convective water vapor as a treatment for lower urinary t

Идентификаторы

NCT: NCT07723378 · MISTER_1.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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