GreenLight XPS Laser System Retrospective Chart Review

GreenLight XPS Laser System for the Treatment of Benign Prostatic Hyperplasia: Evaluation of Safety, Efficacy, and Quality of Life Through Retrospective Chart Review

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: GreenLight XPS Laser System

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.

• Study Type: Observational
• Enrollment (Actual): 956

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • University of Montreal Hospital Center
• United States
  • California
    • Mountain View, California, United States, 94040
      • El Camino Urology Medical Group, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Georgia Urology
  • Michigan
    • Westland, Michigan, United States, 48186
      • Affiliates Division, Comprehensive Urology
  • Texas
    • Houston, Texas, United States, 77027
      • Houston Metro Urology
  • Virginia
    • Virginia Beach, Virginia, United States, 23462
      • Urology of Virginia, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GreenLight XPS Laser System; Treatment of BPH in men using the GreenLight XPS Laser System and the MoXy fiber	Device: GreenLight XPS Laser System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Prostate Symptom Score (IPSS)	Evaluate the proportion of subjects who have mild or no BPH symptoms at six months post-procedure; e.g. an IPSS of eight or less at 6-month follow-up. An IPSS of eight or less indicates the subject is asymptomatic or has mild symptoms, a score of 9-21 indicates the subject has moderate symptoms, and a score of >21 indicates the subject has severe symptoms. IPSS scores can range from 0-35.	6 months post-procedure
Occurrence of Adverse Events Related to the Study Treatment.	Treatment-related adverse events include: Event related to the study device or procedure; Intra-operative adverse event related to the study device or procedure; Serious adverse events related to the study device or procedure The number of events as well as the number and percentage of subjects with the event will be calculated.	365 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of the Study Procedure	Summary of the study procedure, including length of procedure and lasing time	Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
Characteristics of the Study Procedure and Immediate Outcomes	Summary of characteristics of the study procedure and immediate outcomes: total energy used (kJ)	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.	Summarize IPSS-QOL from baseline through six months post-procedure for all data available during the retrospective review. The quality of life assessment responses includes: Delighted, Pleased, Mostly Satisfied, Mixed-neither satisfied or dissatisfied, Mostly Dissatisfied, Unhappy, or Terrible (range of 0 to 6).The results presented below represent the change from baseline to six months post-procedure for any response. Lower scores indicate a better outcome.	Baseline through six months post-procedure
Assess Changes in Objective Measures of Urologic Function.	Changes in objective measures of urologic function from baseline through six months post-procedure using Peak Flow Rate (Qmax)	Baseline through six months post-procedure.
Number of Participants With ER Visits, Hospital Admissions, and Surgical Re-treatments for Treatment-related Adverse Events Up to 90 Days Post-Procedure	Emergency room visit for an adverse event related to the study device or procedure within 90 days of procedure; Hospital admission for an adverse event related to the study device or procedure within 90 days of procedure; Surgical intervention for an adverse event related to the study device or procedure within 90 days of procedure	Up to 90 days post-procedure.
Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence	The percentage (count/n) of subjects with an ongoing urinary incontinence event at 90 and 180 days post-procedure. An incontinence event is considered ongoing if the onset was on or before the specified time point and the event is either unresolved or resolved after that time point.	90 days, 180 days
Assess the Occurrence of Surgical Retreatment for BPH in GreenLight XPS Patients.	Number of surgical re-treatment for BPH as a result of prostate tissue regrowth or insufficient prostatic tissue removal.	Procedure through five years post-procedure.
Characteristics of the Study Procedure and Immediate Outcomes	Summarize characteristics of the study procedure and immediate outcomes: length of catheterization	Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
Length of Hospital Stay	Summarize length of hospital stay (in days) from admission through discharge	The number of days from admission through discharge from the medical facility will be measured.
Type of Hospital Stay	Summarize characteristics of the type of hospital stay (in-patient vs out-patient with an overnight stay)	Data will be collected during the time of their hospital stay from admission through discharge
Number of Participants Stratified by Number of Fibers Used During Procedure	Summarize characteristics of the study procedure and immediate outcomes: number of fibers used	Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
Assess Changes in Objective Measures of Urologic Function	Changes in objective measures of urologic function from baseline through six months post-procedure using post void residual	Baseline through six months post-procedure
Changes in Objective Measures of Urologic Function	Changes in objective measures of urologic function from baseline through six months post-procedure using prostate volume	Baseline through six months post-procedure.
Assess Changes in Objective Measures of Urologic Function.	Changes in objective measures of urologic function from baseline through six months post-procedure using prostate specific antigen	From baseline through six months post-procedure.

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Mahmood A. Hai, M.D., Affiliates Division, Comprehensive Urology

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: May 13, 2014
• First Submitted That Met QC Criteria: May 14, 2014
• First Posted (Estimate): May 16, 2014

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: PE1401