EEAP Using Moses 2.0 Technology vs the Thulium Fiber Laser in Medium-Large Prostates
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-90
SponsorFundacio Puigvert
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males aged between 40 and 90 years.
Patients who, due to their lower urinary tract symptoms, are candidates for
Obstructive urinary symptoms evaluated through IPSS with a score >7 and QoL > 2 or acute urinary reten on refractory to catheter removal.
Obstructive urinary flow evaluated through uroflowmetry with Qmax< 15 ml/s, obstruction demonstrated by pressure/flow study, prostatic origin haematuria refractory to medical treatment, or acute urinary retention refractory to catheter removal.
Disqualifiers
Diagnosis, suspicion, or history of urethral stenosis or urethral surgery.
History of prostate surgery or pelvic radiotherapy.
Diagnosis or suspicion of prostate cancer or urothelial cancer.
Body mass index superior to 30.
Trial design
Design model
Parallel
Treatments tested in this trial
MoLEP
Procedure/SurgeryPatients 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.
ThuFLEP
Procedure/SurgeryPatients 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Endoscopic Prostate Enucleation Using Moses 2.0 TechnologyActive comparator 1 intervention
Group B: Endoscopic Prostate Enucleation Using the New Thulium Fiber LaserActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
SURGICAL TIME
Difference in surgical time between MoLEP and ThuFLEP in prostates larger than 80 cc.
Time frame
Total time of Surgery procedureSecondary outcomes
1
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).
Time frame
From date of preoperative blood test to date of control blood test postoperatively within 24 hours after surgery2
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).
Time frame
From date and time of end of surgery to date and time of hospital discharge assessed up to 1 month3
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.
Time frame
From date of surgery to date of the end of follow-up 3 years4
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.
Time frame
From date of enrollment to date of the end of follow-up 3 yearsSponsors and contacts
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Source ClinicalTrials.gov