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

Phase 4

Completed

• Conditions: Benign Prostatic Hyperplasia (BPH)
• Interventions: Device: Greenlight XPS Laser; Device: BiVAP Saline Vaporization of the prostate

• Registration Number: NCT01500057
• Lead Sponsor: Brooklyn Urology Research Group

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 study consists of a screening phase, treatment, followed by follow-up visits at 1 week, 4 weeks, 3 months, 6 months, and 12 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-16
• Study First Submitted QC: 2011-12-23
• Study First Posted: 2011-12-26
• Primary Completion: 2016-10-10
• Study Completion: 2016-10-10
• Status Verified: 2018-04
• Results First Submitted: 2018-04-13
• Results First Submitted QC: 2018-04-13
• Last Update Submitted: 2018-04-13
• Results First Posted: 2018-05-14
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Greenlight XPS Laser	Greenlight XPS Laser	Greenlight XPS Laser of the prostate
BiVAP Saline Vaporization	BiVAP Saline Vaporization of the prostate	BiVAP Saline Vaporization of the prostate

Primary Outcome Measures

Name	Time	Method
Change From Baseline in American Urological Association Symptom Score	Baseline and 12 months	The American Urological Association Symptom Score range is 0-35 with 35 being the most severe urinary symptoms
Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax)	baseline and 12 months	maximum urinary flow rate was measures using uroflow device

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to 12 Months in Post Void Residual Volume	baseline and 12 months	post void residual was measured using a bladder scan device

Trial Locations

Locations (1)

Brooklyn Urology Research Group; 🇺🇸 Brooklyn, New York, United States