Evaluating the effectiveness of Rezum water vapor therapy for prostate enlargement
Prospective Observational Study on Water Vapor Thermal Therapy in Management of Patients With Benign Prostatic Hyperplasia (BPH)
Saint Vincent's Hospital, Korea · NCT06656689
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | Saint Vincent's Hospital, Korea (other) |
| Locations | 1 site (Suwon, Gyeonggi-do) |
| Trial ID | NCT06656689 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men aged 50 or older with a prostate size between 30cc and 80cc who are scheduled for Rezum surgery.
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.
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 performed: Previous studies on Rezum therapy have shown promising results, indicating its potential effectiveness in treating benign prostatic hyperplasia.
Eligibility criteria
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 this trial is running
Suwon, Gyeonggi-do
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Benign Prostatic Hyperplasia, Rezum, Water Vapor Thermal Therapy