EEAP Using Moses 2.0 Technology Vs the Thulium Fiber Laser in Medium-Large Prostates

Puigvert Foundation

Status: Enrolling

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

Treatments: Procedure: ThuFLEP; Procedure: MoLEP

Study type: Interventional

Funder types: Other

Identifiers

NCT06565741

C-2024-23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Male

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Endoscopic Prostate Enucleation Using Moses 2.0 Technology

Active Comparator group

Description:

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

Treatment:

Procedure: MoLEP

Endoscopic Prostate Enucleation Using the New Thulium Fiber Laser

Active Comparator group

Description:

Thulium Fiber laser to endoscopic prostate enucleation (ThuFLEP).

Treatment:

Procedure: ThuFLEP