Clinical trial NCT02139969: GreenLight XPS Laser System Retrospective Chart Review
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-05-16
Enrollment: 956
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of males who have had the GreenLight XPS procedure with the MoXy fiber on or after 01-Aug-2010. The cohort will be selected from six pre-selected urology clinics in the US and one pre-selected urology clinic in Canada.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: 6 months post-procedure
measure: Occurrence of Adverse Events Related to the Study Treatment.
timeFrame: 365 Days
Secondary outcomes:
measure: Characteristics of the Study Procedure
timeFrame: Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
measure: Characteristics of the Study Procedure and Immediate Outcomes
timeFrame: Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
measure: Assess Changes in Quality of Life Related to BPH Symptoms.
timeFrame: Baseline through six months post-procedure
measure: Assess Changes in Objective Measures of Urologic Function.
timeFrame: Baseline through six months post-procedure.
measure: Number of Participants With ER Visits, Hospital Admissions, and Surgical Re-treatments for Treatment-related Adverse Events Up to 90 Days Post-Procedure
timeFrame: Up to 90 days post-procedure.
measure: Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence
timeFrame: 90 days, 180 days
measure: Assess the Occurrence of Surgical Retreatment for BPH in GreenLight XPS Patients.
timeFrame: Procedure through five years post-procedure.
measure: Characteristics of the Study Procedure and Immediate Outcomes
timeFrame: Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
measure: Length of Hospital Stay
timeFrame: The number of days from admission through discharge from the medical facility will be measured.
measure: Type of Hospital Stay
timeFrame: Data will be collected during the time of their hospital stay from admission through discharge
measure: Number of Participants Stratified by Number of Fibers Used During Procedure
timeFrame: Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
measure: Assess Changes in Objective Measures of Urologic Function
timeFrame: Baseline through six months post-procedure
measure: Changes in Objective Measures of Urologic Function
timeFrame: Baseline through six months post-procedure.
measure: Assess Changes in Objective Measures of Urologic Function.
timeFrame: From baseline through six months post-procedure.
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: El Camino Urology Medical Group, Inc.
state: California
city: Atlanta
country: United States
facility: Georgia Urology
state: Georgia
city: Westland
country: United States
facility: Affiliates Division, Comprehensive Urology
state: Michigan
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: Virginia Beach
country: United States
facility: Urology of Virginia, PLLC
state: Virginia
city: Montreal
country: Canada
facility: University of Montreal Hospital Center
state: Quebec
Study officials:
affiliation: Affiliates Division, Comprehensive Urology
name: Mahmood A. Hai, M.D.
role: PRINCIPAL_INVESTIGATOR
References: