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

NCT ID: NCT06177821

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2025-12-30

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 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.

Conditions

Prostatic Hyperplasia of the Medial Lobe

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A, 5 seconds

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

Group Type: EXPERIMENTAL

Rezum®

Intervention Type: DEVICE

Rezum® Water vaporization device

Group B, 9 seconds

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

Group Type: EXPERIMENTAL

Rezum®

Intervention Type: DEVICE

Rezum® Water vaporization device

Interventions

Rezum®

Rezum® Water vaporization device

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sung Yong Cho

M.D., Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Sung Yong Cho, M.D.,Ph.D.

Role: primary

kmoretry@daum.net

+82-2-870-2394

Other Identifiers

REZUM

Identifier Type: -

Identifier Source: org_study_id