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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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ClinicalTrials.gov Identifier: NCT01500057
Recruitment Status : Completed
First Posted : December 26, 2011
Results First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Collaborators:
American Medical Systems
Richard Wolf Medical Instruments Corporation (RWMIC)
Information provided by (Responsible Party):
Ivan Grunberger, MD, Brooklyn Urology Research Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia (BPH) Device: Greenlight XPS Laser Device: BiVAP Saline Vaporization of the prostate Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2011
Actual Primary Completion Date : October 10, 2016
Actual Study Completion Date : October 10, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500057


Locations
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United States, New York
Brooklyn Urology Research Group
Brooklyn, New York, United States, 11215
Sponsors and Collaborators
Brooklyn Urology Research Group
American Medical Systems
Richard Wolf Medical Instruments Corporation (RWMIC)
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Ivan Grunberger, MD, Medical Director, Brooklyn Urology Research Group
ClinicalTrials.gov Identifier: NCT01500057    
Other Study ID Numbers: WIRB Protocol# 20111638
First Posted: December 26, 2011    Key Record Dates
Results First Posted: May 14, 2018
Last Update Posted: May 14, 2018
Last Verified: April 2018
Keywords provided by Ivan Grunberger, MD, Brooklyn Urology Research Group:
enlarged prostate
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases