Rezum for 30-80ml Patients With Moderate-severe LUTS to Study Surgical Principles for Median Lobe Enlargement

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 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 of decisions for the location, vapor time, and the number of injections contributes to the Rezum procedure configuration for the median lobe treatment being safer and standardizer.

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.