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Recruiting NCT07723378

MISTER Study: Minimally Invasive Steam Therapy - Russian Effectiveness Registry

No phase Interventional Benign Prostate Hypertrophy(BPH) LUTS(Lower Urinary Tract Symptoms)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rezūm.
Who it may be relevant to
Registry conditions: Benign Prostate Hypertrophy(BPH), LUTS(Lower Urinary Tract Symptoms). Basic parameters: 18 years — 85 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Primary outcome measures

  • Rate of Rezūm therapy failure [Time frame: 12 months]
Secondary outcome measures (7)
  • Post-void residual urine volume [Time frame: 14 days]
  • International Prostate Symptom Score (IPSS) [Time frame: 3, 6, and 12 months]
  • Qmax [Time frame: 3, 6, and 12 months]
  • Prostate volume [Time frame: 3, 6, and 12 months]
  • PSA level [Time frame: 3, 6, and 12 months]
  • International Index of Erectile Function (IIEF-5) [Time frame: 3, 6, and 12 months]
  • Rate of de novo retrograde ejaculation [Time frame: 3, 6, and 12 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Russia · 1 center
  • Institute for Urology and Reproductive Health, Sechenov University — Moscow

Publications

  • 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

Identifiers

NCT: NCT07723378 · MISTER_1.0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗