A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)

A single-arm open label pilot study observing intraoperative and postoperative outcomes of the Beacon Platform in HoLEP.

Inclusion criteria

• Male
• Subject has diagnosis of lower urinary tract symptoms and/or urinary retention due to benign prostatic enlargement causing bladder outlet obstruction,
• Subject is able and willing to comply with all the assessments of the study,
• Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the informed consent form,
• ≥ 45 years of Age,
• Prostate volume 40 - 120 cc by transrectal ultrasound (TRUS), magnetic resonance imaging (MRI), or computed tomography (CT), measured within one year prior to procedure,
• The subject is indicated for undergoing HoLEP procedure

Exclusion criteria

• Urethral stricture, meatal stenosis, or bladder neck contracture - either current or recurrent,
• History of prostate cancer or current/suspected bladder cancer,
• Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds,
• History of other diseases causing voiding dysfunction including urinary retention (e.g., diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.),
• Subjects with overactive bladder in the absence of benign prostatic obstruction as determined by the investigator,
• Acute urinary tract infection (UTI) or finding of asymptomatic bacteriuria (Note: subject can be enrolled if the UTI is treated)
• Previous pelvic irradiation or radical pelvic surgery,
• Previous prostate surgery, including enucleation, resection, vaporization, thermotherapy, ablation, stenting, or prostatic urethral lift,
• Inability to stop taking anticoagulants for at least 3 days prior to the procedure or antiplatelets and/or coumadin for at least 5 days prior to the procedure (Note: low dose aspirin therapy is permitted),
• Any severe illness that would prevent complete study participation or confound study results.
• Bleeding tendency disorders,
• Future fertility concerns,
• Subject has any other disease or condition(s) that would interfere with completion of the study and follow-up assessments, would increase risks of the procedure, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect outcomes,
• Concomitant participation in another interventional study