Evaluating the effectiveness of Rezum water vapor therapy for prostate enlargement
Official title: Prospective Observational Study on Water Vapor Thermal Therapy in Management of Patients With Benign Prostatic Hyperplasia (BPH)
Run by Saint Vincent's Hospital, Korea · NCT06656689 · Data updated 2026-11-12
This study is testing if Rezum water vapor therapy can safely help men over 50 with prostate enlargement feel better and improve their symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 50 Years and up |
| Sex | Men only |
| Enrollment | 300 (estimated) |
| Sponsor | Saint Vincent's Hospital, Korea Academic / other |
| Locations | 1 site (Suwon, Gyeonggi-do) |
| Status | Recruiting |
| Started | July 31, 2023 |
| Main results expected | July 31, 2028 |
| Study ends | October 31, 2028 |
| Registry record updated | November 6, 2024 |
| Trial ID | NCT06656689 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men aged 50 or older with a prostate size between 30cc and 80cc who are scheduled for Rezum surgery.
✕Probably not a fit
Patients with suspected prostate cancer or urinary tract infections, as well as those unable to complete follow-up, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the safety and efficacy of Rezum water vapor thermal therapy in patients with benign prostatic hyperplasia (BPH). The study will enroll male participants aged 50 or older, who will undergo the Rezum procedure, which delivers steam directly into the prostate tissue to reduce its size. Participants will be monitored for at least three months post-treatment to evaluate outcomes related to efficacy and safety. The study is conducted in a day-surgery setting, minimizing recovery time for patients.
Why it matters
Potential benefit: If successful, this therapy could provide a minimally invasive treatment option for men suffering from benign prostatic hyperplasia, improving their quality of life.
How similar studies have gone: Previous studies on Rezum therapy have shown promising results, indicating its potential effectiveness in treating benign prostatic hyperplasia.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Saint Vincent's Hospital
Suwon, Gyeonggi-do, South Korea Recruiting
Study contacts
- Principal investigator: Hee Youn Kim, M.D., Ph.D. — St Vincent's Hospital
- Study coordinator: Hee Youn Kim, M.D., Ph.D.
- Email: khyoun10589@gmail.com
- Phone: 82-10-9024-6533
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Sonablate HIFU Registry for Prostate Cancer and BPH
This registry collects real-world data from men treated with Sonablate HIFU to see how well it works and how it affects urinary and sexual function over the long term.
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Tamsulosin alone vs. tamsulosin with tadalafil for troublesome urinary symptoms from enlarged prostate
This study tests whether adding tadalafil to tamsulosin helps men with BPH see better urinary symptoms and quality of life, using two tadalafil doses over 12 weeks.
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Tamsulosin With or Without Tadalafil for a Trial Without Catheter After Acute Urinary Retention
This study tests whether adding tadalafil to tamsulosin helps men with a first episode of acute urinary retention due to enlarged prostate pass urine without needing a catheter.
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Tamsulosin dose change or switch to silodosin before catheter removal in men with BPH-related acute urinary retention
This trial tests whether continuing tamsulosin, increasing its dose, or switching to silodosin helps men with BPH-related acute urinary retention go without a catheter after seven days.
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Water Vapor Therapy vs Ejaculation-Sparing Enucleation for Benign Prostatic Hyperplasia
This study tests whether Water Vapor Thermal Therapy (Rezum) or an ejaculation-sparing enucleation procedure better helps sexually active men with bothersome BPH symptoms.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.