GreenLight XPS Laser System Retrospective Chart Review

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139969
• Other study ID #: PE1401
• Status: Completed
• Start date: May 2014
• Est. completion date: November 2014

Study information

• Verified date: January 2018
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 956
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• GreenLight XPS Laser System

Locations

Country	Name	City	State
Canada	University of Montreal Hospital Center	Montreal	Quebec
United States	Georgia Urology	Atlanta	Georgia
United States	Houston Metro Urology	Houston	Texas
United States	El Camino Urology Medical Group, Inc.	Mountain View	California
United States	Urology of Virginia, PLLC	Virginia Beach	Virginia
United States	Affiliates Division, Comprehensive Urology	Westland	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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.