RecruitingNot Applicable

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

Spain130 participantsStarted 2025-04-01

Plain-language 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.

Who can participate

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Postoperative hospital stay

Timeframe: From date and time of end of surgery to date and time of hospital discharge assessed up to 1 month

Trial details

NCT IDNCT06649357

SponsorFundacio Puigvert

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-11

Contact for this trial

Ivan Schwartzmann Jochamowitz, MD

0034934169700 ischwartzm@fundacio-puigvert.es

View on ClinicalTrials.gov More Prostate Hyperplasia trials

Plain-language summary

Who can participate

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.