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.
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
956
El Camino Urology Medical Group, Inc.
Mountain View, California, United States
Georgia Urology
Atlanta, Georgia, United States
Affiliates Division, Comprehensive Urology
Westland, Michigan, United States
Houston Metro Urology
Houston, Texas, United States
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.
Time frame: 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.
Time frame: 365 Days
Characteristics of the Study Procedure
Summary of the study procedure, including length of procedure and lasing time
Time frame: 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)
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.
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.
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Urology of Virginia, PLLC
Virginia Beach, Virginia, United States
University of Montreal Hospital Center
Montreal, Quebec, Canada
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline through six months post-procedure.