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

NCT06649357 | Recruiting FDA Device

• 1 other identifier: C2024 35
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 6

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.

Conditions

Prostate Hyperplasia; Surgery; Endoscopic Anatomical Enucleation of the Prostate (EEAP)

Keywords

Prostate hyperplasia; Surgery; Endoscopic anatomical enucleation of the prostate (EEAP)

Outcome Measures

Primary Outcomes (1)

• Postoperative hospital stay

  Variation in length of hospital stay after each procedure. Difference in postoperative hospital stay time between MoLEP and BiTURP. Number of hours in the hospital after the procedure if finished, organized in the following categories: Outpatient procedure (less than 16 hours), 1 day of hospitalization (≤ 24 hours), 2 days of hospitalization (≤ 48 hours), 3 days of hospitalization (≤ 72 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

Secondary Outcomes (5)

• SURGICAL TIME

  Total time of Surgery procedure

• The bladder catheterization time

  Total time of bladder catheterization procedure

• Perioperative complications

  From date of surgery to date of the end of follow-up 5 years

• TREATMENT

  From date of surgery to date of the end of follow-up 5 years

• Urinary symptoms

  From date of enrollment to date of the end of follow-up 5 years

Study Arms (2)

MoLEP

ACTIVE COMPARATOR

Endoscopic Prostate Enucleation Using Moses 2.0 Technology Pulse modulation technology in Moses 2.0applied to Holmium Laser Endoscopic Prostate (MoLEP).

Device: MoLEP

BiTURP

ACTIVE COMPARATOR

Bipolar Transurethral Resection of the Prostate

Device: BiTURP

Interventions

MoLEP DEVICE

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 BiTURP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50cases) and possessing experience with both laser types, will perform the surgical procedure.

MoLEP

BiTURP DEVICE

Patients with an indication for surgery for BPH viaEEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or BiTURP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50cases) and possessing experience with both laser types, will perform the surgical procedure.

BiTURP

Eligibility Criteria

• Gender Eligibility Details: Males with an indication for BPH surgery with a prostatic volume \>80cc measured by urological ultrasound or magnetic resonance imaging (MRI).
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio Puigvert: lead

Study Sites (6)

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

RECRUITING

Fundacio Puigvert

Barcelona, BARCELONA, 08025, Spain

RECRUITING

Hospital Univesitari de Bellvitge

L'Hospitalet de Llobregat, BARCELONA, 08907, Spain

NOT YET RECRUITING

Hospital Universitario Marqués de Valdecillas

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Universitario de Cabueñes

Gijón, Principality of Asturias, 33394, Spain

RECRUITING

Hospital Universitario Río Hortega

Valladolid, Valladolid, 47012, Spain

RECRUITING

Related Publications (9)

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  PMID: 33285214 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010 Jun 1;152(11):726-32. doi: 10.7326/0003-4819-152-11-201006010-00232. Epub 2010 Mar 24.

  PMID: 20335313 BACKGROUND

• Dowd K, ElMansy H, Sharour W, Kotb A, Shaver C, El Tayeb MM. Wolf Piranha vs Storz Prostate Morcellation Devices: A Retrospective Multi-Institutional Study. J Endourol. 2021 Nov;35(11):1671-1674. doi: 10.1089/end.2020.0541.

  PMID: 34128395 BACKGROUND

• Gauhar V, Gilling P, Pirola GM, Chan VW, Lim EJ, Maggi M, Teoh JY, Krambeck A, Castellani D. Does MOSES Technology Enhance the Efficiency and Outcomes of Standard Holmium Laser Enucleation of the Prostate? Results of a Systematic Review and Meta-analysis of Comparative Studies. Eur Urol Focus. 2022 Sep;8(5):1362-1369. doi: 10.1016/j.euf.2022.01.013. Epub 2022 Jan 31.

  PMID: 35105516 BACKGROUND

• Zhang Y, Yuan P, Ma D, Gao X, Wei C, Liu Z, Li R, Wang S, Liu J, Liu X. Efficacy and safety of enucleation vs. resection of prostate for treatment of benign prostatic hyperplasia: a meta-analysis of randomized controlled trials. Prostate Cancer Prostatic Dis. 2019 Dec;22(4):493-508. doi: 10.1038/s41391-019-0135-4. Epub 2019 Feb 28.

  PMID: 30816336 BACKGROUND

• Kuntz RM, Lehrich K, Ahyai SA. Holmium laser enucleation of the prostate versus open prostatectomy for prostates greater than 100 grams: 5-year follow-up results of a randomised clinical trial. Eur Urol. 2008 Jan;53(1):160-6. doi: 10.1016/j.eururo.2007.08.036. Epub 2007 Aug 28.

  PMID: 17869409 BACKGROUND

• Naspro R, Suardi N, Salonia A, Scattoni V, Guazzoni G, Colombo R, Cestari A, Briganti A, Mazzoccoli B, Rigatti P, Montorsi F. Holmium laser enucleation of the prostate versus open prostatectomy for prostates >70 g: 24-month follow-up. Eur Urol. 2006 Sep;50(3):563-8. doi: 10.1016/j.eururo.2006.04.003. Epub 2006 May 2.

  PMID: 16713070 BACKGROUND

• Gravas S, Gacci M, Gratzke C, Herrmann TRW, Karavitakis M, Kyriazis I, Malde S, Mamoulakis C, Rieken M, Sakalis VI, Schouten N, Speakman MJ, Tikkinen KAO, Cornu JN. Summary Paper on the 2023 European Association of Urology Guidelines on the Management of Non-neurogenic Male Lower Urinary Tract Symptoms. Eur Urol. 2023 Aug;84(2):207-222. doi: 10.1016/j.eururo.2023.04.008. Epub 2023 May 17.

  PMID: 37202311 BACKGROUND

• Freyer PJ. A New Method of Performing Perineal Prostatectomy. Br Med J. 1900 Mar 24;1(2047):698-9. doi: 10.1136/bmj.1.2047.698-a. No abstract available.

  PMID: 20758920 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ivan Schwartzmann Jochamowitz, MD

  Fundacio Puigvert

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan Schwartzmann Jochamowitz, MD

CONTACT

0034934169700; ischwartzm@fundacio-puigvert.es

Silvia Mateu, MD

CONTACT

0034934169700; smateu@fundacio-puigvert.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients who are candidates according to standard medical practice for BPH surgery with a prostate volume ≤ 80 cc measured by urological ultrasound or magnetic resonance imaging (MRI). Surgery will be randomly assigned using MoLEP or Bi-TURP.

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 18, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be available when the study results are published.
• Access Criteria: Open

Locations

ES (6)