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

Brooklyn Urology Research Group

Status and phase

Completed

Phase 4

Conditions

Benign Prostatic Hyperplasia (BPH)

Treatments

Device: BiVAP Saline Vaporization of the prostate

Device: Greenlight XPS Laser

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01500057

WIRB Protocol# 20111638

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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