Clinical trial NCT06565741: EEAP Using Moses 2.0 Technology Vs the Thulium Fiber Laser in Medium-Large Prostates
Official title: Prospective and Randomized Analysis of Endoscopic Prostate Enucleation Using Moses 2.0 Technology Versus the New Thulium Fiber Laser in Medium and Large Prostates.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostatic Hyperplasia
Surgery
Endoscopic Anatomical Enucleation of the Prostate (EEAP)
Keywords: Medium and Large Prostates
Endoscopic Prostate Enucleation
Endoscopic anatomical enucleation of the prostate (EEAP)
Holmium laser
Thulium Fiber laser
Moses 2.0 Technology
Lead sponsor: Fundacio Puigvert
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 120
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 ThuFLEP.
Primary purpose: TREATMENT

Brief summary: Introduction: Endoscopic anatomical enucleation of the prostate (EEAP) with lasers has emerged as an effective and less invasive surgical option compared to traditional methods. Among the various available laser options, Holmium laser and Thulium Fiber laser have stood out as two prominent approaches for performing endoscopic prostate enucleation. These technologies have 3 showcased their effectiveness in ablating prostatic tissue and improving urinary symptoms. Nevertheless, differences in their physical properties and modes of action may impact their success rates and clinical outcomes. In our institution it is standard practice to use one laser or the other according to their availability in the operating room.

Primary Objective: To demonstrate the superiority of MoLEP over ThuFLEP in terms of enucleation efficiency.

Secondary Objectives: a) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of perioperative bleeding.

b) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of postoperative hospital stay.

c) To demonstrate the non-inferiority of ThuFLEP compared to ThuFLEP in terms of perioperative complications.

d) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in urinary symptoms.

e) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in flowmetric variables.

Study Type: Prospective, randomized, non-blind, multicentric clinical trial. Intervention: 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 ThuFLEP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50 cases) and possessing experience with both laser types, will perform the surgical procedure.

Detailed description: Surgery and Follow-up Schedule

* Surgeries will be performed between September 2024 and September 2025.
* Initial follow-up at 3 months.
* Completion of the first phase of the study: March 2026.

Scheduled of Visits: Selection Visit, 1-Month Postoperative Visit, 3-Month Follow-up, 6-Month Follow-up, Annual Follow-up Visit (1-3 years).

Sample size calculation was done using the main outcome variable (total surgical time). Previous studies indicate that surgical time for ThuFLEP is 71.6 minutes \[8\]. The time for MoLEP may be at least 5 minutes less. Accepting an alpha risk of 5% and a beta risk of 20% in a two-tailed test, a total of 120 patients are needed (60 in each study group). A common standard deviation of 9 minutes change is assumed. A loss to follow-up rate of 15% has been estimated.

Randomization between the two surgery groups will be performed using the Efron procedure to balance the groups in terms of the number of subjects. The calculation will be carried out with the !RndSeq macro for SPSS Statistics. It will be conducted centrally by a person independent of the surgeon.

Statistical Analysis: For quantitative variables, measures of central tendency and dispersion will be .provided. Normality tests will be conducted using the Shapiro-Wilk test. For qualitative variables, valid percentages will be shown. Sociodemographic and clinical data, as well as the main study variables, will be compared between study groups using the Student's t-test (Mann-Whitney U test in case of non-normality). Chi-square test or Fisher's test (if any observed frequency is \<5) will be used for qualitative variables. A multivariate linear regression model will be constructed to determine variables related to surgical time. Beta coefficients and 95% confidence intervals (CI) will be determined. A preliminary study will be conducted on potential confounding and interacting factors. Adjustment will be made for clinically or bibliographically relevant variables. Interaction will be tested using the likelihood ratio test. A significant difference will be accepted in all tests with a p-value \<0.05. R Studio statistical package (V2.5.1) will be used for data analysis.

Eligibility criteria: Inclusion Criteria:

* Males aged between 40 and 90 years.
* Patients who, due to their lower urinary tract symptoms, are candidates for

BPH surgery, including:

* Obstructive urinary symptoms evaluated through IPSS with a score \&gt;7 and QoL \&gt; 2 or acute urinary reten on refractory to catheter removal.
* Obstructive urinary flow evaluated through uroflowmetry with Qmax\&lt; 15 ml/s, obstruction demonstrated by pressure/flow study, prostatic origin haematuria refractory to medical treatment, or acute urinary retention refractory to catheter removal.

  * Prostatic volume measured by transabdominal ultrasound, transrectal ultrasound, or magnetic resonance imaging of more than 80 cc.
  * Prostate-specific antigen (PSA) \&lt; 4 ng/ml, or with multiparametric prostate magnetic resonance imaging reporting PIRADS \&lt; 3 or equal to 3 with PSA density \&lt; 15%.

Exclusion Criteria:

* Diagnosis, suspicion, or history of urethral stenosis or urethral surgery.
* History of prostate surgery or pelvic radiotherapy.
* Diagnosis or suspicion of prostate cancer or urothelial cancer.
* Body mass index superior to 30.

Primary outcomes:
measure: SURGICAL TIME
timeFrame: Total time of Surgery procedure
Secondary outcomes:
measure: Perioperative bleeding
timeFrame: From date of preoperative blood test to date of control blood test postoperatively within 24 hours after surgery
measure: Postoperative hospital stay
timeFrame: From date and time of end of surgery to date and time of hospital discharge assessed up to 1 month
measure: Perioperative complications
timeFrame: From date of surgery to date of the end of follow-up 3 years
measure: Urinary symptoms
timeFrame: From date of enrollment to date of the end of follow-up 3 years
measure: Flowmetric variables maximum flow
timeFrame: From date of surgery to date of the end of follow-up 3 years
measure: Flowmetric variables average flow
timeFrame: From date of surgery to date of the end of follow-up 3 years
measure: Flowmetric variables post-void residual
timeFrame: From date of surgery to date of the end of follow-up 3 years
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Univesitari de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Fundacio Puigvert
city: Barcelona
country: Spain
facility: Clinic Hospital of Barcelona
Study officials:
affiliation: Fundacio Puigvert
name: Ivan Schwartzmann Jochamowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Enikeev D, Glybochko P, Okhunov Z, Alyaev Y, Rapoport L, Tsarichenko D, Enikeev M, Sorokin N, Dymov A, Taratkin M. Retrospective Analysis of Short-Term Outcomes After Monopolar Versus Laser Endoscopic Enucleation of the Prostate: A Single Center Experience. J Endourol. 2018 May;32(5):417-423. doi: 10.1089/end.2017.0898. Epub 2018 Mar 13.
citation: Nottingham CU, Large T, Agarwal DK, Rivera ME, Krambeck AE. Comparison of Newly Optimized Moses Technology vs Standard Holmium:YAG for Endoscopic Laser Enucleation of the Prostate. J Endourol. 2021 Sep;35(9):1393-1399. doi: 10.1089/end.2020.0996. Epub 2021 Jul 15.
citation: Wani MM, Sriprasad S, Bhat T, Madaan S. Is Thulium laser enucleation of prostate an alternative to Holmium and TURP surgeries - A systematic review? Turk J Urol. 2020 Nov;46(6):419-426. doi: 10.5152/tud.2020.20202. Epub 2020 Oct 9.
citation: Fraundorfer MR, Gilling PJ. Holmium:YAG laser enucleation of the prostate combined with mechanical morcellation: preliminary results. Eur Urol. 1998;33(1):69-72. doi: 10.1159/000019535.
citation: Elmansy H, Hodhod A, Elshafei A, Noureldin YA, Mehrnoush V, Zakaria AS, Hadi RA, Fathy M, Abbas L, Kotb A, Shahrour W. Comparative analysis of MOSESTM technology versus novel thulium fiber laser (TFL) for transurethral enucleation of the prostate: A single-institutional study. Arch Ital Urol Androl. 2022 Jun 29;94(2):180-185. doi: 10.4081/aiua.2022.2.180.
citation: 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.
citation: Enikeev D, Netsch C, Rapoport L, Gazimiev M, Laukhtina E, Snurnitsyna O, Alekseeva T, Becker B, Taratkin M, Glybochko P. Novel thulium fiber laser for endoscopic enucleation of the prostate: A prospective comparison with conventional transurethral resection of the prostate. Int J Urol. 2019 Dec;26(12):1138-1143. doi: 10.1111/iju.14115. Epub 2019 Sep 22.