Overview

This trial is active, not recruiting.

Condition benign prostatic hyperplasia (bph)
Treatments greenlight xps laser, bivap saline vaporization of the prostate
Phase phase 4
Sponsor Brooklyn Urology Research Group
Collaborator American Medical Systems
Start date December 2011
End date July 2016
Trial size 60 participants
Trial identifier NCT01500057, WIRB Protocol# 20111638

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Greenlight XPS Laser of the prostate
greenlight xps laser
Treatment of BPH with Greenlight XPS laser
(Active Comparator)
BiVAP Saline Vaporization of the prostate
bivap saline vaporization of the prostate
treatment of BPH with BiVAP Saline Vaporization

Primary Outcomes

Measure
AUA Symptom score
time frame: Baseline and 12 months

Secondary Outcomes

Measure
uroflow and post void residual
time frame: baseline and 12 months

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Brooklyn Urology Research Group.