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NCT Number: NCT07723378

MISTER Study: Minimally Invasive Steam Therapy - Russian Effectiveness Registry

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.

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Key information

Conditions

Benign Prostate Hypertrophy(BPH) Genital Diseases Genital Diseases, Male LUTS(Lower Urinary Tract Symptoms) Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Urology and Reproductive Health, Sechenov University

Moscow, 119435, Russia

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rezūm

Procedure

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.

Other names: convective water vapor thermal ablation, minimally invasive treatment

Primary outcomes

  1. Rate of Rezūm therapy failure

    Time frame: 12 months

    Rate of Rezūm therapy failure within 12 months after the intervention, defined as the occurrence of at least one of the following events:

    • Resumption or continuation of medical therapy for LUTS/BPH
    • Repeat surgical intervention for BPH
    • Failure to restore voiding

Secondary outcomes

  1. Post-void residual urine volume

    Time frame: 14 days

    14 days

  2. International Prostate Symptom Score (IPSS)

    Time frame: 3, 6, and 12 months

    Mild LUTS (symptom score less than of equal to 7) Moderate LUTS (symptom score range 8-19) Severe LUTS (symptom score range 20-35)

  3. Qmax

    Time frame: 3, 6, and 12 months

  4. Prostate volume

    Time frame: 3, 6, and 12 months

  5. PSA level

    Time frame: 3, 6, and 12 months

  6. International Index of Erectile Function (IIEF-5)

    Time frame: 3, 6, and 12 months

    severe ED (5-7), moderate ED (8-11), mild to moderate ED (12-16), mild ED (17-21), and no ED (22-25)

  7. Rate of de novo retrograde ejaculation

    Time frame: 3, 6, and 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Vladislav Petov

CONTACT

[email protected]

+7 925 351 75 49

Sponsors and collaborators

Lead sponsor

Sechenov University

Other

Collaborators

  • Avicenna Clinical Hospital
  • European Medical Center
  • Liniya Zhizni LLC
  • MEDSI Group of Companies
  • N. A. Semashko Railway Clinical Hospital ("RZD-Meditsina")
  • N. I. Pirogov Clinic of High Medical Technologies
  • Neftyanik Medical and Sanitary Unit
  • RTH (Real Trans Hair) Medical Center
  • Russian University of Medicine
  • S. P. Botkin Moscow Multidisciplinary Scientific and Clinical Center
  • SM-Clinic Multidisciplinary Medical Holding
  • St. Luke's Clinical Hospital
  • UGMK-Zdorovie Medical Center
  • URO-PRO Clinic

Registry information

Acronym: MISTER

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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