Outpatient Holmium LASER Enucleation of the Prostate: Benefit of MOSES(TM) 2.0 Technology

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Mar 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called Holmium Laser Enucleation of the Prostate (HoLEP), which is used to treat a condition known as Benign Prostatic Hypertrophy (BPH), where the prostate gland becomes enlarged and causes urinary problems. The trial aims to see if using a new technology called MOSES 2.0 can improve the success of this outpatient surgery. This means that patients might be able to go home the same day after the procedure instead of staying in the hospital.

To participate in this study, men must be over 50 years old and have significant symptoms from BPH that require surgery. They should have a certain size of prostate and specific scores indicating their urinary difficulties. However, there are some reasons a person might not be eligible, such as having had previous prostate surgery or certain health conditions that would make surgery risky. Participants can expect to undergo a procedure that aims to relieve their symptoms and improve their quality of life, with the added benefit of using the advanced MOSES 2.0 technology.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Subject over 50 years old
• • BPH whose symptoms require surgical management
• • Preoperative prostate volume measured by ultrasound (suprapubic or transrectal) ≥ 40g
• • IPSS score \> 15 and Quality of Life score ≥ 3
• • Maximum urinary output (Qmax) \< 15 ml/sec
• Exclusion Criteria:
• • Inability to read or write French
• • Patients with comorbidities contraindicating general anesthesia
• • Patients not eligible for outpatient care according to French recommendations (high risk of complications after general anesthesia, place of residence more than 150 km from an emergency department, alone at home the night following the intervention) .
• • History of BPH surgery
• • History of prostate cancer
• • Preoperative prostate volume measured by ultrasound (suprapubic or transrectal) \< 40g
• • Existence or history of urethral stricture
• • Existence or suspicion of a "neurological" bladder
• • Positive preoperative cytobacteriological examination not treated appropriately
• • Adult patients subject to a legal protection measure or unable to express their consent
• • Patients deprived of liberty by a judicial or administrative decision or hospitalized without consent or admitted to a health or social establishment for purposes other than research