Treatment for enlarged prostate using the Rezum technique
Feasibility of Water Vaporization (Rezum®) for Patients With ≥ 30 and < 80 ml With Moderate-severe LUTS to Establish the Surgical Principles for Prominent or Non-prominent Median Lobe Enlargement: A Single-center, Prospective, Pilot Study
This study is testing the Rezum technique to see if it can safely and effectively help men with enlarged prostates and bothersome urinary symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | Male |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06177821 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of the Rezum technique for treating prostatic hyperplasia, particularly focusing on patients with moderate to severe lower urinary tract symptoms and median lobe enlargement. It involves systematic decision-making regarding the treatment's location, vapor time, and number of injections to standardize and enhance the safety of the procedure. The study aims to provide a clearer understanding of how to optimize the Rezum procedure for patients with specific prostate conditions.
Who should consider this trial
Good fit: Ideal candidates are men aged 50 to 85 with benign prostatic hyperplasia between 30 and 80 ml and moderate to severe urinary symptoms.
Not a fit: Patients with a history of prostate or bladder cancer, significant urinary retention, or prior prostate surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve urinary symptoms and quality of life for patients suffering from prostatic hyperplasia.
How similar studies have performed: Other studies have shown promising results with the Rezum technique for treating prostatic hyperplasia, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 50 to 85 years who have been diagnosed with benign prostatic hyperplasia at Seoul National University Hospital and are scheduled to undergo endoscopic surgery. * benign prostatic hyperplasia ≥ 30 and \< 80 ml * Patients who have given written informed consent to participate in the study according to their age * A urinary symptom score (International ProstateSymptom Score \[IPSS\] moderated (8-19 points) to severe (20-35 points) * Measured Postvoiding Residual (PVR) \<250 mL Exclusion Criteria: * History of prostate or bladder cancer, neurogenic bladder, bladder calculus, or clinically significant bladder diverticulum * Active infection, treatment for chronic prostatitis * Diagnosis of urethral stricture, meatal stenosis or bladder neck contracture, damaged external urinary sphincter, stress urinary incontinence, post-void residual \>300 mL or urinary retention, or prior prostate surgery * Men taking anticoagulants or on bladder anticholinergics or with severe cardiovascular disease * PSA greater than 4.0 ng/ml (unless prostate cancer was ruled out by biopsy) * Allergy to device materials, immune suppressants or corticosteroids use, and serious medical or mental illness.
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
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.