The Clinical Efficacy of Rezūm Therapy Versus Bipolar Trans-urethral Resection of the Prostate for Treatment Benign Prostatic Hyperplasia

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 1, 2021

Primary Completion Date

June 1, 2023

Study Completion Date

September 1, 2023

Conditions
Prostatic Hyperplasia
Interventions
PROCEDURE

Rezum procedure

In Rezūm procedure, the Rezūm System (NxThera Inc., Maple Grove, MN, USA) consists of a radiofrequency (RF) power supply generator and single-use transurethral delivery device. Starting 1 cm distal to the bladder neck, injection was done at 3 and 9 o'clock sites. The needle was inserted for 9 s duration, retracted, and then delivered to another treatment site in 1 cm distance distal to the previous one.

PROCEDURE

B-TURP procedure

In B-TURP, Olympus SurgMaster™ UES-40 bipolar generator (Olympus Europe, Hamburg, Germany) was used. Current's settings used were cut/coag 200/120. Using continuous flow 26Fr resectoscope first resection of the median lobe from the level of the bladder neck to the apex of the prostate was done followed by resection of the lateral lobes. Using Ellic evacuator, Prostatic chips were extracted from the field. A 22 fr three-way silicon Foley catheter was placed with traction applied and the balloon inflated by normal saline of 30-80 cc according to the size of the prostate.

Trial Locations (1)

11566

Ain Shams University, Cairo

All Listed Sponsors
lead

Ain Shams University

OTHER