NCT06116370

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

Two-Year Follow-Up Comparing Rezūm Therapy Versus Bipolar Transurethral Resection of the Prostate for Treating Benign Prostatic Hyperplasia. A Prospective Randomized Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

We aimed to compare the efficacy and safety of Rezūm therapy and bipolar transurethral resection of prostate (B-TURP) for the management of benign prostatic hyperplasia (BPH) of 50-120gm size.

Detailed description

For decades, Transurethral resection of the prostate (TURP) was the gold standard surgical intervention for small and moderate prostates, however it has high morbidity and prolonged hospital stay. In contrast to monopolar TURP (M-TURP), where prolonged resection carries the risk of transurethral resection (TUR) syndrome, bipolar transurethral resection of prostate (B-TURP), especially in large prostates was a promising procedure for urologists, but unfortunately, the morbidity rate of B-TURP remains high \[4\]. Therefore, newer minimally invasive procedures have been introduced to provide alternative surgical options to TURP. Rezūm is a radiofrequency made water vapour thermal treatment. It has recently been added to the international guidelines as a choice for medical treatment resistant lower urinary tract symptoms (LUTS). The AUA and Canadian Urological Association (CUA) guidelines now add water vapour therapy as a treatment option for BPH patients with small prostate size \<80 gm and for those wishing to maintain antegrade ejaculation. While they still offer no clear recommendation to Rezūm use for those with large prostates. Early studies on this topic have found out promising results.

Conditions

• Prostatic Hyperplasia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-06-01
• Completion: 2023-09-01
• First posted: 2023-11-03
• Last updated: 2023-11-07

Locations

1 site across 1 country: Egypt