Trial Outcomes & Findings for Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia (NCT NCT01500057)

NCT ID: NCT01500057

Last Updated: 2018-05-14

Results Overview

The American Urological Association Symptom Score range is 0-35 with 35 being the most severe urinary symptoms

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 66 participants
• Primary outcome timeframe: Baseline and 12 months
• Results posted on: 2018-05-14

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	31	35
Overall Study COMPLETED	25	31
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Measure	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
Overall Study Lost to Follow-up	6	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Greenlight XPS Laser n=31 Participants Greenlight XPS Laser of the prostate Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser	BiVAP Saline Vaporization n=35 Participants BiVAP Saline Vaporization of the prostate BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization	Total n=66 Participants Total of all reporting groups
Age, Continuous	69.5 years STANDARD_DEVIATION 8.1 • n=93 Participants	65.5 years STANDARD_DEVIATION 10.0 • n=4 Participants	67.4 years STANDARD_DEVIATION 9.2 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	31 Participants n=93 Participants	35 Participants n=4 Participants	66 Participants n=27 Participants
Region of Enrollment United States	31 Participants n=93 Participants	35 Participants n=4 Participants	66 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: All people who completed the study and had data available

The American Urological Association Symptom Score range is 0-35 with 35 being the most severe urinary symptoms

Outcome measures

Measure	Greenlight XPS Laser n=23 Participants Greenlight XPS Laser of the prostate Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser	BiVAP Saline Vaporization n=27 Participants BiVAP Saline Vaporization of the prostate BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization
Change From Baseline in American Urological Association Symptom Score	-14.7 units on a scale Standard Deviation 9.0	-10.5 units on a scale Standard Deviation 8.6

PRIMARY outcome

Timeframe: baseline and 12 months

Population: all participants who completed the study and have available data

maximum urinary flow rate was measures using uroflow device

Outcome measures

Measure	Greenlight XPS Laser n=23 Participants Greenlight XPS Laser of the prostate Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser	BiVAP Saline Vaporization n=24 Participants BiVAP Saline Vaporization of the prostate BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization
Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax)	5.9 ml/sec Standard Deviation 8.6	2.3 ml/sec Standard Deviation 8.3

SECONDARY outcome

Timeframe: baseline and 12 months

Population: all participants who completed the study and have available data

post void residual was measured using a bladder scan device

Outcome measures

Measure	Greenlight XPS Laser n=23 Participants Greenlight XPS Laser of the prostate Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser	BiVAP Saline Vaporization n=24 Participants BiVAP Saline Vaporization of the prostate BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization
Change From Baseline to 12 Months in Post Void Residual Volume	-61.9 ml Standard Deviation 104.0	-36.7 ml Standard Deviation 122.2

Adverse Events

Greenlight XPS Laser

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

BiVAP Saline Vaporization

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Greenlight XPS Laser n=31 participants at risk Greenlight XPS Laser of the prostate Greenlight XPS Laser: Treatment of BPH with Greenlight XPS laser	BiVAP Saline Vaporization n=35 participants at risk BiVAP Saline Vaporization of the prostate BiVAP Saline Vaporization of the prostate: treatment of BPH with BiVAP Saline Vaporization
Renal and urinary disorders urethral stricture	0.00% 0/31 • 12 months	8.6% 3/35 • Number of events 3 • 12 months
Renal and urinary disorders urinary retention	6.5% 2/31 • Number of events 2 • 12 months	2.9% 1/35 • Number of events 1 • 12 months

Additional Information

Ivan Grunberger, M.D. Medical Director

Brooklyn Urology Research Group

Phone: 718-230-7788

Email: ivg9002@nyp.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place