Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia
This trial is active, not recruiting.
|Condition||benign prostatic hyperplasia (bph)|
|Treatments||greenlight xps laser, bivap saline vaporization of the prostate|
|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|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
AUA Symptom score
time frame: Baseline and 12 months
uroflow and post void residual
time frame: baseline and 12 months
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
|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|
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