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

Launched by FUNDACIO PUIGVERT · Aug 19, 2024

Keywords

ClinConnect Summary

This clinical trial is comparing two different laser treatments for men with enlarged prostates, a condition known as benign prostatic hyperplasia (BPH). The study is specifically looking at a technique called endoscopic anatomical enucleation of the prostate (EEAP) using two types of lasers: the Moses 2.0 technology (MoLEP) and the Thulium Fiber laser (ThuFLEP). The researchers want to find out if the MoLEP method is better at removing prostate tissue efficiently while also checking if it causes less bleeding and leads to a shorter hospital stay than the ThuFLEP method.

To participate in this trial, men aged 40 to 90 who have urinary problems due to BPH and have a prostate size larger than 80 cc may be eligible. Participants will have their surgery assigned at random to either the MoLEP or ThuFLEP method, performed by an experienced surgeon. Throughout the study, participants can expect to be monitored for their recovery and improvements in urinary symptoms. It’s important to note that individuals with certain conditions, such as a history of prostate cancer or specific urinary problems, will not be able to participate in this trial.

Gender

MALE

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 \>7 and QoL \> 2 or acute urinary reten on refractory to catheter removal.
• • Obstructive urinary flow evaluated through uroflowmetry with Qmax\< 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) \< 4 ng/ml, or with multiparametric prostate magnetic resonance imaging reporting PIRADS \< 3 or equal to 3 with PSA density \< 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.