GreenLight XPS Laser System Retrospective Chart Review

Boston Scientific

Status: Completed

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: GreenLight XPS Laser System

Study type: Observational

Funder types: Industry

Identifiers

NCT02139969

PE1401

Details and patient eligibility

About

The purpose of this study is to gain information on the safety, efficacy, and quality of life in subjects who have had the GreenLight XPS procedure.

Full description

This is a retrospective chart review conducted at six centers in the United States and Canada. This review will evaluate the safety and efficacy of GreenLight XPS in subjects who received treatment on or after 01-Aug-2010.

Enrollment: 956 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men who have had a GreenLight XPS procedure with a MoXy Fiber since 01-Aug-2010.

Exclusion criteria

• Subject has had prior radiation.
• Subject has a diagnosis of neurogenic bladder confirmed by urodynamic studies (BOO, detrusor overactivity (DO), impaired detrusor contractor (IDC))
• Subject has a neurologic disorder that would impact bladder function (MS, Parkinson, Spinal Cord Injury) (note: Stroke patients not excluded)
• Subject has an artificial urinary sphincter

Trial design

956 participants in 1 patient group

GreenLight XPS Laser System

Description:

Treatment of BPH in men using the GreenLight XPS Laser System and the MoXy fiber

Treatment:

Device: GreenLight XPS Laser System