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