GreenLight XPS Laser System Retrospective Chart Review

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: GreenLight XPS Laser System


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GreenLight XPS Laser System<br>Treatment of BPH in men using the GreenLight XPS Laser System and the MoXy fiber | Device: GreenLight XPS Laser System<br> <br> |

What is the study measuring?
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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. |