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

Seoul National University

Status: Enrolling

Conditions: Prostatic Hyperplasia of the Medial Lobe

Treatments: Device: Rezum®

Study type: Interventional

Funder types: Other

Identifiers

NCT06177821

REZUM

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: Male

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Group A, 5 seconds

Experimental group

Description:

Patients with benign prostatic hyperplasia featuring a small median lobe enlargement will be allocated to the 5-second Rezum therapy group.

Treatment:

Device: Rezum®

Group B, 9 seconds

Experimental group

Description:

Patients with benign prostatic hyperplasia featuring a big prominent median lobe enlargement will be allocated to the 9-second Rezum therapy group.

Treatment:

Device: Rezum®