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

April 13, 2018 updated by: Ivan Grunberger, MD, Brooklyn Urology Research Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11215
        • Brooklyn Urology Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Greenlight XPS Laser
Greenlight XPS Laser of the prostate
Device: Greenlight XPS Laser
Treatment of BPH with Greenlight XPS laser
Active Comparator: BiVAP Saline Vaporization
BiVAP Saline Vaporization of the prostate
Device: BiVAP Saline Vaporization of the prostate
treatment of BPH with BiVAP Saline Vaporization

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to 12 Months in Post Void Residual Volume
Time Frame: baseline and 12 months
post void residual was measured using a bladder scan device
baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brooklyn Urology Research Group

Collaborators

American Medical Systems
Richard Wolf Medical Instruments Corporation (RWMIC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

October 10, 2016

Study Completion (Actual)

October 10, 2016

Study Registration Dates

First Submitted

December 16, 2011

First Submitted That Met QC Criteria

December 23, 2011

First Posted (Estimate)

December 26, 2011

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

April 13, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIRB Protocol# 20111638

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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