EEAP Using Moses 2.0 Technology vs the Thulium Fiber Laser in Medium-Large Prostates
NCT Number: NCT06565741
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prostatic Hyperplasia|Surgery|Endoscopic Anatomical Enucleation of the Prostate (EEAP)
Interventions: PROCEDURE: MoLEP|PROCEDURE: ThuFLEP
Sponsor: Fundacio Puigvert
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-03
Completion Date: 2028-09
Locations: Hospital Univesitari de Bellvitge, Hospitalet de Llobregat, Barcelona, 08907, Spain|Fundacio Puigvert, Barcelona, 08025, Spain|Clinic Hospital of Barcelona, Barcelona, 08036, Spain

Summary:
Introduction: Endoscopic anatomical enucleation of the prostate (EEAP) with lasers has emerged as an effective and less invasive surgical option compared to traditional methods. Among the various available laser options, Holmium laser and Thulium Fiber laser have stood out as two prominent approaches for performing endoscopic prostate enucleation. These technologies have 3 showcased their effectiveness in ablating prostatic tissue and improving urinary symptoms. Nevertheless, differences in their physical properties and modes of action may impact their success rates and clinical outcomes. In our institution it is standard practice to use one laser or the other according to their availability in the operating room.

Primary Objective: To demonstrate the superiority of MoLEP over ThuFLEP in terms of enucleation efficiency.

Secondary Objectives: a) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of perioperative bleeding.

b) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of postoperative hospital stay.

c) To demonstrate the non-inferiority of ThuFLEP compared to ThuFLEP in terms of perioperative complications.

d) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in urinary symptoms.

e) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in flowmetric variables.

Study Type: Prospective, randomized, non-blind, multicentric clinical trial. Intervention: 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 ThuFLEP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50 cases) and possessing experience with both laser types, will perform the surgical procedure.

Primary Outcome Measures: SURGICAL TIME, Difference in surgical time between MoLEP and ThuFLEP in prostates larger than 80 cc., Total time of Surgery procedure
Secondary Outcome Measures: Perioperative bleeding, Differences in perioperative bleeding between MoLEP and ThuFLEP. Difference in haemoglobin level between preoperative blood test and control blood test postoperatively within 24 hours after surgery)., From date of preoperative blood test to date of control blood test postoperatively within 24 hours after surgery|Postoperative hospital stay, Difference in postoperative hospital stay time between MoLEP and ThuFLEP. Number of days of hospitalization after surgery. Three categories will be recorded: Ambulatory (\<16 hours of stay), Less than 24 hours, More than 24 hours (individual length of stay will be recorded)., From date and time of end of surgery to date and time of hospital discharge assessed up to 1 month|Perioperative complications, Difference in the incidence of perioperative complications between MoLEP and ThuFLEP. All possible complications will be recorded and classified according to the Clavien- Dindo scale from date of surgery to end of study., From date of surgery to date of the end of follow-up 3 years|Urinary symptoms, Difference in improvement of urinary symptoms after MoLEP compared to ThuFLEP. IPSS questionnaire will be performed in all study visits: Changes in total score and quality of life score before and after surgery will be compared between patients undergoing MoLEP and ThuFLEP., From date of enrollment to date of the end of follow-up 3 years|Flowmetric variables maximum flow, Difference in improvement of flowmetric values after MoLEP compared to ThuFLEP. Uroflowmetry will be performed at baseline, 3 months, 6 months and annual follow-up visits: Changes in maximum flow measured in ml/s before and after surgery will be compared between patients undergoing MoLEP and ThuFLEP.

A uroflowmetry will be considered valid if the patient reports that it is representative of their current voiding quality and if it presents a voided volume \> 150 ml., From date of surgery to date of the end of follow-up 3 years|Flowmetric variables average flow, Difference in improvement of flowmetric values after MoLEP compared to ThuFLEP. Uroflowmetry will be performed at baseline, 3 months, 6 months and annual follow-up visits: Changes in average flow measured in ml/s before and after surgery will be compared between patients undergoing MoLEP and ThuFLEP.

A uroflowmetry will be considered valid if the patient reports that it is representative of their current voiding quality and if it presents a voided volume \> 150 ml., From date of surgery to date of the end of follow-up 3 years|Flowmetric variables post-void residual, Difference in improvement of flowmetric values after MoLEP compared to ThuFLEP. Uroflowmetry will be performed at baseline, 3 months, 6 months and annual follow-up visits: Changes in post-void residual measured in ml before and after surgery will be compared between patients undergoing MoLEP and ThuFLEP.

A uroflowmetry will be considered valid if the patient reports that it is representative of their current voiding quality and if it presents a voided volume \> 150 ml., From date of surgery to date of the end of follow-up 3 years