Clinical trial Recruiting at 1 site Interventional Ages 18 to 85 Men only

MISTER: Steam Therapy for BPH in real-world practice

Official title: MISTER Study: Minimally Invasive Steam Therapy - Russian Effectiveness Registry

Run by Sechenov University · NCT07723378 · Data updated 2026-11-12

This study tests Rezūm steam therapy for men with moderate-to-severe BPH and LUTS to see how well it works in real-world clinics.

Quick facts

Study typeInterventional
Ages18 Years to 85 Years
SexMen only
Enrollment1400 (estimated)
SponsorSechenov University
Academic / other
Locations1 site (Moscow)
StatusRecruiting
StartedAugust 1, 2026
Main results expectedAugust 2027
Study endsSeptember 2027
Registry record updatedJuly 23, 2026
Trial IDNCT07723378 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men with BPH experiencing moderate-to-severe LUTS (IPSS ≥8, QoL ≥3), prostate volume 30–150 cm³, Qmax ≤15 mL/s, and post-void residuals <300 mL who are considering Rezūm treatment.

Probably not a fit

Patients with active prostate cancer, acute urinary tract or prostate infections, neurogenic bladder, bladder stones, urethral strictures, prior prostate surgery, or those who do not consent to use of data may not benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The MISTER study is a multicenter registry that collects real-world outcomes of Rezūm minimally invasive water vapor therapy for benign prostatic hyperplasia. It aims to describe symptom changes, urinary flow, and safety after treatment in typical clinical settings. Eligible participants have BPH-related LUTS with specific prostate size and urinary flow criteria, and data are gathered from routine care rather than a controlled experimental environment. The registry seeks to identify factors linked to temporary urinary retention, need for repeat treatment, and ejaculatory changes, and to help standardize success criteria. Results will reflect everyday practice across several Russian medical centers.

Why it matters

Potential benefit: If successful, patients may experience sustained improvement in urinary symptoms and quality of life with a minimally invasive option that preserves ejaculation for many men.

How similar studies have gone: Prior clinical experiences with Rezūm show symptom relief and preserved ejaculation; this registry builds real-world evidence rather than a randomized trial, so findings may be complementary to controlled studies.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Institute for Urology and Reproductive Health, Sechenov University
    Moscow, Russia
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.