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

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.

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.