Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia

An Open-Label Randomized Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia

This is a Phase 4, prospective, open-label, randomized study of Greenlight XPS Laser versus BiVAP Saline Vaporization of the prostate in men with symptomatic Benign Prostatic Hyperplasia (BPH). The study consists of a screening phase, treatment, followed by follow-up visits at 1 week, 4 weeks, 3 months, 6 months, and 12 months.

Inclusion Criteria:

• male over the age of 18 years
• present with symptomatic/ obstructive symptoms secondary to PBH requiring surgical intervention
• subjects must read, understand and sign the Informed Consent
• AUA ≥ 15
• Qmax < 15mL/sec
• Stopped BPH medication. Alpha blockers 15 days 5-α-reductase 3 months
• Prostate volume ≥ 30g

Exclusion Criteria:

• PVR > 300ml
• Current urine retention
• Previous surgical or invasive treatments (TURP, TUMT, TUNA)
• PSA ≥ 4 (must have negative biopsy within last 12 months)
• Neurogenic bladder
• Obstruction due to urethral stricture
• Any disorder or condition of the subject that the investigator believes will counter indicate their inclusion in the study