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

Benign Prostatic Hyperplasia (BPH) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500057
• Other study ID #: WIRB Protocol# 20111638
• Status: Completed
• Phase: Phase 4
• Start date: December 2011
• Est. completion date: October 10, 2016

Study information

• Verified date: April 2018
• Source: Brooklyn Urology Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 10, 2016
• Est. primary completion date: October 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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-a-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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• Greenlight XPS Laser
Treatment of BPH with Greenlight XPS laser
• BiVAP Saline Vaporization of the prostate
treatment of BPH with BiVAP Saline Vaporization

Locations

Country	Name	City	State
United States	Brooklyn Urology Research Group	Brooklyn	New York

Sponsors (3)

Lead Sponsor	Collaborator
Brooklyn Urology Research Group	American Medical Systems, Richard Wolf Medical Instruments Corporation (RWMIC)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change From Baseline to 12 Months in Post Void Residual Volume	post void residual was measured using a bladder scan device	baseline and 12 months