MISTER Study: Minimally Invasive Steam Therapy - Russian Effectiveness Registry

Summary

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.

Conditions

• Benign Prostate Hypertrophy(BPH)
• LUTS(Lower Urinary Tract Symptoms)

Interventions

PROCEDURE

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.

Sponsors & Collaborators

• Russian University of Medicine

  collaborator UNKNOWN

• N. I. Pirogov Clinic of High Medical Technologies

  collaborator UNKNOWN

• UGMK-Zdorovie Medical Center

  collaborator UNKNOWN

• SM-Clinic Multidisciplinary Medical Holding

  collaborator UNKNOWN

• MEDSI Group of Companies

  collaborator UNKNOWN

• URO-PRO Clinic

  collaborator UNKNOWN

• Avicenna Clinical Hospital

  collaborator UNKNOWN

• Neftyanik Medical and Sanitary Unit

  collaborator UNKNOWN

• St. Luke's Clinical Hospital

  collaborator UNKNOWN

• N. A. Semashko Railway Clinical Hospital ("RZD-Meditsina")

  collaborator UNKNOWN

• Liniya Zhizni LLC

  collaborator UNKNOWN

• S. P. Botkin Moscow Multidisciplinary Scientific and Clinical Center

  collaborator UNKNOWN

• European Medical Center

  collaborator UNKNOWN

• RTH (Real Trans Hair) Medical Center

  collaborator UNKNOWN

• Sechenov University

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2027-08-31

Completion

2027-09-30

Countries

• Russia

Study Locations