NCT07723378

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 20, 2026

Last Update Submit

July 20, 2026

Conditions

Benign Prostate Hypertrophy(BPH)LUTS(Lower Urinary Tract Symptoms)

Keywords

BPHLUTSwater vapor thermal ablationminimally invasive treatment

Outcome Measures

Primary Outcomes (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

    12 months

Secondary Outcomes (7)

  • Post-void residual urine volume

    14 days

  • International Prostate Symptom Score (IPSS)

    3, 6, and 12 months

  • Qmax

    3, 6, and 12 months

  • Prostate volume

    3, 6, and 12 months

  • PSA level

    3, 6, and 12 months

  • +2 more secondary outcomes

Study Arms (1)

Rezūm therapy

EXPERIMENTAL

Convective water vapor thermal ablation for benign prostatic hyperplasia

Procedure: Rezūm

Interventions

RezūmPROCEDURE

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
Rezūm therapy

Eligibility Criteria

Age18 Years - 85 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsBPH
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Urology and Reproductive Health, Sechenov University

Moscow, 119435, Russia

RECRUITING

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Prostatic HyperplasiaLower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Vladislav Petov

CONTACT

+7 925 351 75 49pettow@mail.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assosiate Professor, urologist

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 23, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)