Back to resultsPhase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia
Primary Purpose
Benign Prostatic Hyperplasia (BPH)
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Greenlight XPS Laser
BiVAP Saline Vaporization of the prostate
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH) focused on measuring enlarged prostate
Eligibility 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
Sites / Locations
- Brooklyn Urology Research Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Greenlight XPS Laser
BiVAP Saline Vaporization
Arm Description
Greenlight XPS Laser of the prostate
BiVAP Saline Vaporization of the prostate
Outcomes
Primary Outcome Measures
Change From Baseline in American Urological Association Symptom Score
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)
maximum urinary flow rate was measures using uroflow device
Secondary Outcome Measures
Change From Baseline to 12 Months in Post Void Residual Volume
post void residual was measured using a bladder scan device
Full Information
NCT ID
NCT01500057
First Posted
December 16, 2011
Last Updated
April 13, 2018
Sponsor
Brooklyn Urology Research Group
Collaborators
American Medical Systems, Richard Wolf Medical Instruments Corporation (RWMIC)
1. Study Identification
Unique Protocol Identification Number
NCT01500057
Brief Title
Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia
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 Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
October 10, 2016 (Actual)
Study Completion Date
October 10, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brooklyn Urology Research Group
Collaborators
American Medical Systems, Richard Wolf Medical Instruments Corporation (RWMIC)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia (BPH)
Keywords
enlarged prostate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Greenlight XPS Laser
Arm Type
Active Comparator
Arm Description
Greenlight XPS Laser of the prostate
Arm Title
BiVAP Saline Vaporization
Arm Type
Active Comparator
Arm Description
BiVAP Saline Vaporization of the prostate
Intervention Type
Device
Intervention Name(s)
Greenlight XPS Laser
Intervention Description
Treatment of BPH with Greenlight XPS laser
Intervention Type
Device
Intervention Name(s)
BiVAP Saline Vaporization of the prostate
Intervention Description
treatment of BPH with BiVAP Saline Vaporization
Primary Outcome Measure Information:
Title
Change From Baseline in American Urological Association Symptom Score
Description
The American Urological Association Symptom Score range is 0-35 with 35 being the most severe urinary symptoms
Time Frame
Baseline and 12 months
Title
Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax)
Description
maximum urinary flow rate was measures using uroflow device
Time Frame
baseline and 12 months
Secondary Outcome Measure Information:
Title
Change From Baseline to 12 Months in Post Void Residual Volume
Description
post void residual was measured using a bladder scan device
Time Frame
baseline and 12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Brooklyn Urology Research Group
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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