Overview

This trial is active, not recruiting.

Condition benign prostatic hyperplasia
Treatment greenlight xps laser system
Sponsor American Medical Systems
Start date May 2014
End date November 2014
Trial size 1000 participants
Trial identifier NCT02139969, PE1401

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
greenlight xps laser system

Primary Outcomes

Measure
Evaluate the proportion of patients who have mild or no BPH symptoms at 2-years post-procedure
time frame: 2-years post-procedure
Evaluate the occurrence of adverse events related to the study treatment.
time frame: Up to 4 years

Secondary Outcomes

Measure
Summarize characteristics of the study procedure and immediate outcomes.
time frame: Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
Assess changes in quality of life related to BPH symptoms.
time frame: Baseline through five years post-procedure
Assess changes in objective measures of urologic function.
time frame: From baseline through five years post-procedure.
Characterize medical attention sought for treatment-related adverse events.
time frame: Up to 90 days post-procedure.
Evaluate the frequency of treatment-related urinary incontinence.
time frame: Up to 12 months post-procedure.
Assess the occurrence of surgical retreatment for BPH in GreenLight XPS patients.
time frame: Procedure through five years post-procedure.

Eligibility Criteria

Male participants of any age.

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

Additional Information

Official title GreenLight XPS Laser System for the Treatment of Benign Prostatic Hyperplasia: Evaluation of Safety, Efficacy, and Quality of Life Through Retrospective Chart Review
Principal investigator Mahmood A. Hai, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by American Medical Systems.