ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Benign Prostatic Hyperplasia (BPH)
Interventions: Device: Greenlight XPS Laser
Device: BiVAP Saline Vaporization of the prostate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Greenlight XPS Laser

Greenlight XPS Laser of the prostate

Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser

BiVAP Saline Vaporization

BiVAP Saline Vaporization of the prostate

BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization


Participant Flow:   Overall Study
    Greenlight XPS Laser   BiVAP Saline Vaporization
STARTED   31   35 
COMPLETED   25   31 
NOT COMPLETED   6   4 
Lost to Follow-up                6                4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Greenlight XPS Laser

Greenlight XPS Laser of the prostate

Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser

BiVAP Saline Vaporization

BiVAP Saline Vaporization of the prostate

BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization

Total Total of all reporting groups

Baseline Measures
   Greenlight XPS Laser   BiVAP Saline Vaporization   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   35   66 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.5  (8.1)   65.5  (10.0)   67.4  (9.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      31 100.0%      35 100.0%      66 100.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   31   35   66 


  Outcome Measures

1.  Primary:   Change From Baseline in American Urological Association Symptom Score   [ Time Frame: Baseline and 12 months ]

2.  Primary:   Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax)   [ Time Frame: baseline and 12 months ]

3.  Secondary:   Change From Baseline to 12 Months in Post Void Residual Volume   [ Time Frame: baseline and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ivan Grunberger, M.D. Medical Director
Organization: Brooklyn Urology Research Group
phone: 718-230-7788
e-mail: ivg9002@nyp.org



Responsible Party: Ivan Grunberger, MD, Brooklyn Urology Research Group
ClinicalTrials.gov Identifier: NCT01500057     History of Changes
Other Study ID Numbers: WIRB Protocol# 20111638
First Submitted: December 16, 2011
First Posted: December 26, 2011
Results First Submitted: April 13, 2018
Results First Posted: May 14, 2018
Last Update Posted: May 14, 2018