Status:
COMPLETED
Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia
Lead Sponsor:
Brooklyn Urology Research Group
Collaborating Sponsors:
American Medical Systems
Richard Wolf Medical Instruments Corporation (RWMIC)
Conditions:
Benign Prostatic Hyperplasia (BPH)
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief 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 st...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2016
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01500057
Start Date
December 1 2011
End Date
October 10 2016
Last Update
May 14 2018
Active Locations (1)
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1
Brooklyn Urology Research Group
Brooklyn, New York, United States, 11215