Benign Prostate Hypertrophy(BPH)MISTERNCT07723378
MISTER Study: Minimally Invasive Steam Therapy - Russian Effectiveness Registry
A study testing Rezūm in people with Benign Prostate Hypertrophy(BPH) and LUTS(Lower Urinary Tract Symptoms), run by Sechenov University at 1 site in Russia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Benign Prostate Hypertrophy(BPH), LUTS(Lower Urinary Tract Symptoms)
- What is being tested?
- Rezūm
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteRussia
- Study dates
- 1 Aug 2026to Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Neurogenic lower urinary tract dysfunction
- Bladder stone(s)
- Urethral stricture
- Prior prostate surgery
Who cannot join
- Patient refusal to allow use of medical data for scientific analysis
- Missing or lost data required for analysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Institute for Urology and Reproductive Health, Sechenov University
Moscow, 119435
About this study
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.
- Being tested
- Rezūm
- Keywords
- BPH, LUTS, water vapor thermal ablation, minimally invasive treatment
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RezūmProcedure or surgery
Also called convective water vapor thermal ablation, minimally invasive treatment
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.
| Study group | Role | What they receive |
|---|---|---|
| Rezūm therapy | Experimental | Convective water vapor thermal ablation for benign prostatic hyperplasia Receives: Procedure: Rezūm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (7)
Post-void residual urine volume
14 days
Measured: 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)
Measured: 3, 6, and 12 months
Qmax
Measured: 3, 6, and 12 months
Prostate volume
Measured: 3, 6, and 12 months
PSA level
Measured: 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)
Measured: 3, 6, and 12 months
Rate of de novo retrograde ejaculation
Measured: 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostate Hypertrophy(BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sechenov University
- Sponsor type
- University, hospital or other
- Collaborators
- Russian University of Medicine, N. I. Pirogov Clinic of High Medical Technologies, UGMK-Zdorovie Medical Center, SM-Clinic Multidisciplinary Medical Holding, MEDSI Group of Companies, URO-PRO Clinic, Avicenna Clinical Hospital, Neftyanik Medical and Sanitary Unit, St. Luke's Clinical Hospital, N. A. Semashko Railway Clinical Hospital ("RZD-Meditsina"), Liniya Zhizni LLC, S. P. Botkin Moscow Multidisciplinary Scientific and Clinical Center, European Medical Center, RTH (Real Trans Hair) Medical Center
- Responsible party
- Principal investigator, Vladislav Petov, Sechenov University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723378
- Sponsor's protocol ID
- MISTER_1.0
- Acronym
- MISTER
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 tract symptomatology due to benign prostatic hyperplasia using the Rezūm® system: evaluation of acute ablative capabilities in the human prostate // Research and Reports in Urology. - 2015. - Vol. 7. - P. 13-18. - DOI: 10.2147/RRU.S74040. 3. McVary K. T., Gange S. N., Gittelman M. C. et al. Minimally invasive prostate convective water vapor energy ablation: a multicenter, randomized, controlled study for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia // The Journal of Urology. - 2016. - Vol. 195, № 5. - P. 1529-1538. - DOI: 10.1016/j.juro.2015.10.181. 4. McVary K. T., Gittelman M. C., Goldberg K. A. et al. Final 5-year outcomes of the multicenter randomized sham-controlled trial of a water vapor thermal therapy for treatment of moderate to severe lower urinary tract symptoms secondary to benign prostatic hyperplasia // The Journal of Urology. - 2021. - Vol. 206, № 3. - P. 715-724. - DOI: 10.1097/JU.0000000000001778. 5. Akgul B., Aydin A., Cakir O. O. et al. Impact of minimally invasive surgical therapies on sexual function in benign prostatic hyperplasia: a systematic review // Minerva Urology and Nephrology. - 2025. - Vol. 77, № 4. - P. 459-471. - DOI: 10.23736/S2724-6051.25.06374-8. 6. Özkaptan O., Sevinç C., Çanakcı C. et al. Comparison of outcome for holmium laser enucleation prostate and Rezum system in benign prostate hyperplasia: a matched pair analysis // World Journal of Urology. - 2025. - Vol. 43, № 1. - Art. 242. - DOI: 10.1007/s00345-025-05644-y. 7. López Alcina E., Fernández Arjona M., Fernández Guzmán E. et al. Exp