Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia
This study is currently recruiting participants.
Verified February 2012 by Brooklyn Urology Research Group
Sponsor:
Brooklyn Urology Research Group
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
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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 |
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
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 June 18, 2013