An interventional study of Rezūm in Benign Prostate Hypertrophy(BPH) and LUTS(Lower Urinary Tract Symptoms), sponsored by Sechenov University. Recruiting at 1 site in Russia. Open to male participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Sechenov University · Not applicable, Interventional, and Treatment
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.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Sechenov University is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Non-Inclusion Criteria
Exclusion Criteria
Convective water vapor thermal ablation for benign prostatic hyperplasia
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.
Also known as: convective water vapor thermal ablation, minimally invasive treatment
Rate of Rezūm therapy failure
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
Time frame: 12 months
Post-void residual urine volume
14 days
Time frame: 14 days
International Prostate Symptom Score (IPSS)
Mild LUTS (symptom score less than of equal to 7) Moderate LUTS (symptom score range 8-19) Severe LUTS (symptom score range 20-35)
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)
severe ED (5-7), moderate ED (8-11), mild to moderate ED (12-16), mild ED (17-21), and no ED (22-25)
Time frame: 3, 6, and 12 months
Rate of de novo retrograde ejaculation
Time frame: 3, 6, and 12 months
Plan to share: No
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