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

Completed · Phase 4

Conditions studied: Benign Prostatic Hyperplasia (BPH)

In brief

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.

Key facts

Study ID

NCT01500057

Run by

Brooklyn Urology Research Group

People needed

66

Starts

2011-12-01

Expected to finish

2016-10-10

Last updated by the study team

2018-05-14

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Brooklyn Urology Research Group — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.