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

NCT01500057 | Completed Phase 4 Results

• 1 other identifier: WIRB Protocol# 20111638
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia (BPH)

Keywords

enlarged prostate

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline and 12 months

• Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax)

  maximum urinary flow rate was measures using uroflow device

  baseline and 12 months

Secondary Outcomes (1)

• Change From Baseline to 12 Months in Post Void Residual Volume

  baseline and 12 months

Study Arms (2)

Greenlight XPS Laser

ACTIVE COMPARATOR

Greenlight XPS Laser of the prostate

Device: Greenlight XPS Laser

BiVAP Saline Vaporization

ACTIVE COMPARATOR

BiVAP Saline Vaporization of the prostate

Device: BiVAP Saline Vaporization of the prostate

Interventions

Greenlight XPS Laser DEVICE

Treatment of BPH with Greenlight XPS laser

Greenlight XPS Laser

BiVAP Saline Vaporization of the prostate DEVICE

treatment of BPH with BiVAP Saline Vaporization

BiVAP Saline Vaporization

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brooklyn Urology Research Group: lead
• American Medical Systems: collaborator
• Richard Wolf Medical Instruments Corporation (RWMIC): collaborator

Study Sites (1)

Brooklyn Urology Research Group

Brooklyn, New York, 11215, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Ivan Grunberger, M.D. Medical Director
• Organization: Brooklyn Urology Research Group

ivg9002@nyp.org

718-230-7788

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: December 16, 2011
• First Posted: December 26, 2011
• Study Start: December 1, 2011
• Primary Completion: October 10, 2016
• Study Completion: October 10, 2016
• Last Updated: May 14, 2018
• Results First Posted: May 14, 2018

Record last verified: 2018-04

Locations

US (1)