Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate
NCT ID: NCT06649357
Last Updated: 2025-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
130 participants
INTERVENTIONAL
2025-04-01
2030-11-30
Brief Summary
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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.
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Detailed Description
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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.
However, the available studies often have short follow-up periods, most do not report on the surgeon's experience with HoLEP, and were based on early laser and morcellation technology. 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, resulting in shorter enucleation, haemostasis, and total surgical times for similar energy delivered. 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.
Hypothesis: MoLEP surgery is superior to Bi-TURP in terms of postoperative stay, bladder catheter duration, blood loss and transfusion rate, without significant functional outcomes, and retreatment rate, with no significant differences in surgical time.
Objectives:
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.
Study Design: This study is a prospective multicentric randomized and controlled trial. The study compares two types of BPH surgery without changing standard medical practice. The CONSORT guidelines for randomized clinical trials will be followed.
Participants: 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).
Intervention: 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.
Surgery and Follow-up Schedule:
* Surgeries will be conducted between November 2024 and April 2025
* Initial 6-month follow-up. Database construction and refinement: 2 months. Statistical analysis: 2 months. Preparation of the final report: 2 months. Completion of the first phase of the study: April 2026.
* Second phase follow-up: 24 months. Database construction and refinement: 2 months. Statistical analysis: 2 months. Preparation of the final report: 2 months. Dissemination of results: 2 months. Completion of the second phase of the study: October 2027
* Third phase follow-up: 5 years. Database construction and refinement: 2 months. Statistical analysis: 2 months. Preparation of the final report: 2 months. Dissemination of results: 2 months. Completion of the third phase of the study: October 2030.
Sample size calculation was calculated based on length of hospital stay. Previous studies indicate that the mean days of hospital stay is around 2,5 days in patients with RTU. The length of hospital stay for patients with MoLEP may be at least 1 day less. Around 10% of patients are treated with antiplatelet agents. In order to perform an analysis according to patients with and without this treatment, the sample size will be increased by 10%. Accepting an alpha risk of 5% and a beta risk of 20% in a two-tailed test, a total of 130 patients are needed (65 in each study group). A common standard deviation of 1 day is assumed. A loss to follow-up rate of 12% has been also estimated.
Statistical Analysis: Qualitative variables will be described with absolute frequencies and percentages. The description of quantitative variables will be performed using the mean, standard deviation (SD), median and quartiles. The Kolmogorov-Smirnov test will be used to assess the normality of distributions.
An initial bivariate intention to treat analysis will be performed in order to analyze potential differences according study groups. The relationship between two qualitative variables will be calculated using the chi-squared test or Fisher's exact test (frequency \<5). Quantitative variables will be compared using the Student's t-test (Mann Whitney. For non-normal distributions), analysis of variance \[ANOVA\] (\> 2 categories), linear regression test and Schea's multiple comparisons test. The linear relationship between the quantitative variables will be calculated using Pearson's correlation coefficient or Spearman's rank correlation test (when variable not normally distributed). Changes at the end of follow up in the main outcomes will be analyzed by Wilcoxon nonparametric test in the case of quantitative variables. The McNemar test will be used for the comparison of categorical variables. A backward stepwise linear regression analysis will be performed in order to determine which factors are independently associated to higher length of hospital stay. Study groups and variables with a p value \<0.2 in the univariate analysis will be included as independent variables. The results will be described with beta coefficient , 95% confidence interval (CI) and p-values. For all the tests, p-values \< 0.05 were considered statistically significant. The statistical package R Studio (V2.5.1) was used for the analyses.
Publications will be made with the results of the study, whether they are positive or negative. There will be at least 3 publication scheduled. This will be the results at 6 months, 2 years, and 5 years of follow up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MoLEP
Endoscopic Prostate Enucleation Using Moses 2.0 Technology Pulse modulation technology in Moses 2.0applied to Holmium Laser Endoscopic Prostate (MoLEP).
MoLEP
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.
BiTURP
Bipolar Transurethral Resection of the Prostate
BiTURP
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.
Interventions
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MoLEP
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.
BiTURP
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
MALE
No
Sponsors
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Fundacio Puigvert
OTHER
Responsible Party
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Ivan Schwartzmann, MD
Principal Investigator
Principal Investigators
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Ivan Schwartzmann Jochamowitz, MD
Role: PRINCIPAL_INVESTIGATOR
Fundacio Puigvert
Locations
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Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Fundacio Puigvert
Barcelona, BARCELONA, Spain
Hospital Univesitari de Bellvitge
L'Hospitalet de Llobregat, BARCELONA, Spain
Hospital Universitario Marqués de Valdecillas
Santander, Cantabria, Spain
Hospital Universitario de Cabueñes
Gijón, Principality of Asturias, Spain
Hospital Universitario Río Hortega
Valladolid, Valladolid, Spain
Countries
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Central Contacts
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Facility Contacts
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Lucía Mosquera, MD
Role: backup
Sergi Beato, MD
Role: backup
References
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Stout TE, Borofsky M, Soubra A. A Visual Scale for Improving Communication When Describing Gross Hematuria. Urology. 2021 Feb;148:32-36. doi: 10.1016/j.urology.2020.10.054. Epub 2020 Dec 5.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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C2024 35
Identifier Type: -
Identifier Source: org_study_id
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