Status:
RECRUITING
Rezum for 30-80ml Patients With Moderate-severe LUTS to Study Surgical Principles for Median Lobe Enlargement
Lead Sponsor:
Seoul National University Hospital
Conditions:
Prostatic Hyperplasia of the Medial Lobe
Eligibility:
MALE
50-85 years
Phase:
NA
Brief Summary
This study was created to determine the safety and efficacy of treating prostatic hyperplasia with or without prominent median lobe enlargement with the REZUM technique. The systematic implementation ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06177821
Start Date
June 3 2024
End Date
December 30 2025
Last Update
April 19 2024
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744