A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial

Vanderbilt University Medical Center

Status and phase: Completed; Phase 3

Conditions: Benign Prostatic Hyperplasia

Treatments: Procedure: Moses laser enucleation of prostate

Study type: Interventional

Funder types: Other

Identifiers

NCT04263987

MOLEP Study

Details and patient eligibility

About

Holmium laser enucleation of the prostate (HOLEP) has proven to be efficacious and safe for the treatment of benign prostatic hypertrophy (BPH). New laser technologies such as the Moses Pulse laser system provide for improved energy delivery which may decrease blood loss and operative time. We seek to evaluate Moses technology for enucleation of the prostate in the setting of BPH.

Full description

This is a single-center, prospective, double-blinded, randomized controlled trial comparing MOLEP to HOLEP. Inclusion criteria included all symptomatic BPH patients desiring enucleation with prostate sizes > 80ccs based on cross-sectional imaging. Patients are randomized in a 1:1 fashion and the study is powered to evaluate for a difference in operative time (i.e. alpha=0.05,N=21 per group). All surgeries will be performed with a 550 μm fiber. At the start of each case, a laser technician would be notified of randomization via envelope and randomize the settings to either Moses or traditional mode. The surgeons and patients were blinded to which mode was used. All surgeries will be performed using a two lobe technique and laser settings between 2J and 20-40Hz. Further recorded endpoints include change in blood loss, reduction in International Prostate Symptom Score (IPSS), improvement in uroflow parameters, and complications postoperatively at 6 weeks.

Enrollment: 60 patients

Sex: Male

Ages: 50 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Any man with clinical symptoms fo BPH requiring surgery who has a prostate sized at greater than 80 grams

Exclusion criteria

• Anyone actively on anticoagulation perioperatively

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Holmium Laser Enucleation of Prostate

Active Comparator group

Description:

Traditional holmium laser enucleation of the prostate as currently performed

Treatment:

Procedure: Moses laser enucleation of prostate

Moses Holmium Laser Enucleation of Prostate

Experimental group

Description:

holmium laser enucleation of the prostate as currently performed but with Moses laser settings activated.

Treatment:

Procedure: Moses laser enucleation of prostate