Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate

Summary

Introduction: Multiple studies have demonstrated the superiority of HoLEP in aspects such as transfusión rates or postoperative stay. On the other hand, no differences have been observed in terms of functional outcomes between both techniques, and surgical times reported in different studies tend to be longer for HoLEP. These results likely contribute to TURP, especially with bipolar energy (Bi-TURP), continuing to be considered by many the gold standard for surgical treatment of BPH.

Sofware and hardware upgrades to the Lumenis Pulse 120H. system in 2017, delivered MOSES 2.0, a single-use laser fibre used to perform MOSES augmented HoLEP (MoLEP). MoLEP has shown to be superior in intraoperative outcomes when compared to traditional HoLEP. The availability of new morcellators might also decrease surgical time for HoLEP. This changing landscape for BPH endoscopic surgery deserves a re-evaluation of the differences between Bi-TURP and MoLEP.

Primary Objective: To compare the hospital stay of patients of patients undergoing MoLEP with those undergoing Bi-TURP.

Secondary objectives:

* To compare the surgical time of MoLEP with that of Bi-TURP.
* To compare the bladder catheterization time aCer MoLEP with that of Bi-TURP.
* To compare the postoperative complication rate patients undergoing MoLEP with those undergoing Bi-TURP.
* To compare functional results of patients undergoing MoLEP with those undergoing Bi-TURP.

This study is a prospective multicentric randomized and controlled trial. The study compares two types of BPH surgery without changing standard medical practice.

The study will include patients who are candidates according to standard medical practice for BPH surgery. Patients will be randomized to one of two groups of treatment.

* The MoLEP group will receive surgical treatment with MoLEP.
* The Bi-TURP group will receive surgical treatment with Bi-TURP. Surgical technique and postoperative care will follow standard clinical practice at each participating centre.

Conditions

• Prostate Hyperplasia
• Surgery
• Endoscopic Anatomical Enucleation of the Prostate (EEAP)

Interventions

DEVICE

MoLEP

Patients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or BiTURP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50cases) and possessing experience with both laser types, will perform the surgical procedure.

DEVICE

BiTURP

Patients with an indication for surgery for BPH viaEEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or BiTURP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50cases) and possessing experience with both laser types, will perform the surgical procedure.

Sponsors & Collaborators

• Fundacio Puigvert

  lead OTHER

Principal Investigators

• Ivan Schwartzmann Jochamowitz, MD · Fundacio Puigvert

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-01

Primary Completion

2030-11-30

Completion

2030-11-30

FDA Device

Yes

Countries

• Spain

Study Locations