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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

December 16, 2011
December 26, 2011
April 13, 2018
May 14, 2018
May 14, 2018
December 2011
October 10, 2016   (Final data collection date for primary outcome measure)
  • 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
  • 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
AUA Symptom score [ Time Frame: Baseline and 12 months ]
Complete list of historical versions of study NCT01500057 on ClinicalTrials.gov Archive Site
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
uroflow and post void residual [ Time Frame: baseline and 12 months ]
Not Provided
Not Provided
 
Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Benign Prostatic Hyperplasia (BPH)
  • Device: Greenlight XPS Laser
    Treatment of BPH with Greenlight XPS laser
  • Device: BiVAP Saline Vaporization of the prostate
    treatment of BPH with BiVAP Saline Vaporization
  • Active Comparator: Greenlight XPS Laser
    Greenlight XPS Laser of the prostate
    Intervention: Device: Greenlight XPS Laser
  • Active Comparator: BiVAP Saline Vaporization
    BiVAP Saline Vaporization of the prostate
    Intervention: Device: BiVAP Saline Vaporization of the prostate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
60
October 10, 2016
October 10, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01500057
WIRB Protocol# 20111638
No
Not Provided
Not Provided
Ivan Grunberger, MD, Brooklyn Urology Research Group
Brooklyn Urology Research Group
  • American Medical Systems
  • Richard Wolf Medical Instruments Corporation (RWMIC)
Not Provided
Brooklyn Urology Research Group
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP