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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Brooklyn Urology Research Group.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
American Medical Systems
Richard Wolf Medical Instruments Corporation (RWMIC)
Information provided by (Responsible Party):
Ivan Grunberger, MD, Brooklyn Urology Research Group
ClinicalTrials.gov Identifier:
NCT01500057
First received: December 16, 2011
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Brooklyn Urology Research Group:

Primary Outcome Measures:
  • AUA Symptom score [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • uroflow and post void residual [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500057

Locations
United States, New York
Brooklyn Urology Research Group Recruiting
Brooklyn, New York, United States, 11215
Contact: Celeste Egan, NP    718-230-1202    ceganBURG@gmail.com   
Principal Investigator: Ivan Grunberger, MD         
Sponsors and Collaborators
Brooklyn Urology Research Group
American Medical Systems
Richard Wolf Medical Instruments Corporation (RWMIC)
  More Information

No publications provided

Responsible Party: Ivan Grunberger, MD, Medical Director, Brooklyn Urology Research Group
ClinicalTrials.gov Identifier: NCT01500057     History of Changes
Other Study ID Numbers: WIRB Protocol# 20111638
Study First Received: December 16, 2011
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Brooklyn Urology Research Group:
enlarged prostate

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014