MISTER Study: Minimally Invasive Steam Therapy - Russian Effectiveness Registry
Recruiting now · Not applicable
Conditions studied: Benign Prostate Hypertrophy(BPH), LUTS(Lower Urinary Tract Symptoms)
In brief
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.
Key facts
- Study ID
- NCT07723378
- Run by
- Sechenov University
- People needed
- 1400
- Starts
- 2026-08-01
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older, up to 85. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Patient refusal to allow use of medical data for scientific analysis
- Missing or lost data required for analysis
Where it is running
- Institute for Urology and Reproductive Health, Sechenov University — Moscow, Russia (enrolling)
Full record on ClinicalTrials.gov
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