NCT06649357 Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate
| NCT ID | NCT06649357 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacio Puigvert |
| Condition | Prostate Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2030-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2025-04-01 with a primary completion date of 2030-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Patients with maximum flow rate \< 15 ml/sec before obstructive surgery or with maximum flow rate \> 15 ml/sec and urodynamic study showing high-flow obstruction defined as bladder outlet obstruction index \> 40. * Patients with moderate to severe lower urinary tract symptoms (LUTS) according to the International Prostate Symptom Score (IPSS). Score between 8 and 35. * Patients with a prostate volume between 40 and 80 cc, measured by urological ultrasound or MRI. Exclusion Criteria: * History of prior prostatic obstructive or urethral surgery. * Diagnosis of prostate neoplasia. * Diagnosis of urothelial neoplasia. * Lack of flowmetry or IPSS data before surgery. * Diagnosis or suspicion of hypo/acontractile detrusor before prostatic obstructive surgery. * Diagnosis or suspicion of neurogenic bladder or neurological disease. * History of pelvic radiation therapy.
Contact & Investigator
Ivan Schwartzmann Jochamowitz, MD
PRINCIPAL INVESTIGATOR
Fundacio Puigvert
Frequently Asked Questions
Who can join the NCT06649357 clinical trial?
This trial is open to male participants only, studying Prostate Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06649357 currently recruiting?
Yes, NCT06649357 is actively recruiting participants. Contact the research team at ischwartzm@fundacio-puigvert.es for enrollment information.
Where is the NCT06649357 trial being conducted?
This trial is being conducted at Santiago de Compostela, Spain, Barcelona, Spain, L'Hospitalet de Llobregat, Spain, Santander, Spain and 2 additional locations.
Who is sponsoring the NCT06649357 clinical trial?
NCT06649357 is sponsored by Fundacio Puigvert. The principal investigator is Ivan Schwartzmann Jochamowitz, MD at Fundacio Puigvert. The trial plans to enroll 130 participants.