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Recruiting Observational

Study on Water Vapor Thermal Therapy

NCT06656689 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2023-07-31
Last updated
2024-11-06

Condition(s) studied

Benign Prostatic Hyperplasia

Investigational drug(s) / intervention(s)

Rezum (water vapor thermal therapy)

Rezum (water vapor thermal therapy): Rezum or water vapor thermal therapy is a procedure that involves injecting steam at 103°C into the prostate tissue to induce necrosis and reduce the size of the enlarged prostate.

Study summary

The goal of this observational study is to learn about the efficacy of Rezum water vapor thermal therapy in benign prostatic hyperplasia patients. The main question it aims to answer is:

* Is Rezum an effective treatment?
* Is Rezum safe?

Participants will be followed up for at least three months after the treatment to evaluate efficacy and safety.

Eligibility

Sex
MALE
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 50 or older * Prostate size between 30cc and 80cc as measured by transrectal ultrasound * Patients scheduled for Rezum surgery for BPH Exclusion Criteria: * Suspected prostate cancer * Suspected urinary tract infection * Inability to complete follow-up * Patients who do not consent to participate in the study

Primary outcome measure(s)

  • International Prostate Symptom Score (IPSS) — From enrollment to three months after treatment
    International Prostate Symptom Score (IPSS) is a validated, reproducible scoring system to assess disease severity and response to therapy for BPH. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
  • Qmax — From enrollment to three months after treatment
    Maximal urine flow rate in uroflowmetry exam

Trial sites (1)

FacilityCityRegionStatus
Saint Vincent's Hospital Suwon Gyeonggi-do Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06656689 on ClinicalTrials.gov ↗ ← All trials in South Korea