NCT06649357Recruiting
Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate
Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate. A Prospective Randomized Multicentric Study
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 17 Oct 2024
- Start date
- Apr 2025
- Primary completion date
- Nov 2030
- Lead sponsor
- Fundacio Puigvert
- NCT number
- NCT06649357
What you commit to
- Study type: Interventional
- Planned participants: 130
- From Apr 2025 to the primary completion date, Nov 2030
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior prostatic obstructive or urethral surgery.
- Lack of flowmetry or IPSS data before surgery.
- Diagnosis or suspicion of hypo/acontractile detrusor before prostatic obstructive surgery.
Other illness
- Diagnosis or suspicion of neurogenic bladder or neurological disease.
- History of pelvic radiation therapy.
Other
- Diagnosis of prostate neoplasia.
- Diagnosis of urothelial neoplasia.
Who the study is looking for
- 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.
Sex: Male · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundació Puigvert Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario de Cabueñes Coordinator of this site? Confirm its status | Gijón | Spain | Recruiting |
| Hospital Univesitari de Bellvitge Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Not yet recruiting |
| Hospital Universitario Marques de Valdecillas Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Complejo Hospitalario Universitario De Santiago De Compostela Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Hospital Universitario Rio Hortega Coordinator of this site? Confirm its status | Valladolid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.