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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
What is being tested?
Rezūm
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
Are there results?
Not yet: the study is under way

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.

Vladislav Petov contact

+7 925 351 75 49

pettow@mail.ru

Russia1 site, 1 recruiting

  • Institute for Urology and Reproductive Health, Sechenov University

    Moscow, 119435

    Recruiting

Other trials in Russia

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 groups in NCT07723378
Study groupRoleWhat they receive
Rezūm therapyExperimentalConvective 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.

  1. 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)

  1. Post-void residual urine volume

    14 days

    Measured: 14 days

  2. 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

  3. Qmax

    Measured: 3, 6, and 12 months

  4. Prostate volume

    Measured: 3, 6, and 12 months

  5. PSA level

    Measured: 3, 6, and 12 months

  6. 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

  7. 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.

  1. First posted23 Jul 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completionAug 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vladislav Petov (+7 925 351 75 49, pettow@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Rezūm therapy failure (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07723378, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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