GreenLight XPS Laser System Retrospective Chart Review
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Device: GreenLight XPS Laser System
- Registration Number
- NCT02139969
- Lead Sponsor
- Boston Scientific Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 956
- Men who have had a GreenLight XPS procedure with a MoXy Fiber since 01-Aug-2010.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description GreenLight XPS Laser System GreenLight XPS Laser System Treatment of BPH in men using the GreenLight XPS Laser System and the MoXy fiber
- Primary Outcome Measures
Name Time Method International Prostate Symptom Score (IPSS) 6 months post-procedure 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.
Occurrence of Adverse Events Related to the Study Treatment. 365 Days 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.
- Secondary Outcome Measures
Name Time Method Type of Hospital Stay Data will be collected during the time of their hospital stay from admission through discharge Summarize characteristics of the type of hospital stay (in-patient vs out-patient with an overnight stay)
Assess Changes in Objective Measures of Urologic Function. From baseline through six months post-procedure. Changes in objective measures of urologic function from baseline through six months post-procedure using prostate specific antigen
Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence 90 days, 180 days 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.
Length of Hospital Stay The number of days from admission through discharge from the medical facility will be measured. Summarize length of hospital stay (in days) from admission through discharge
Number of Participants Stratified by Number of Fibers Used During Procedure Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days. Summarize characteristics of the study procedure and immediate outcomes: number of fibers used
Changes in Objective Measures of Urologic Function Baseline through six months post-procedure. Changes in objective measures of urologic function from baseline through six months post-procedure using prostate volume
Assess Changes in Quality of Life Related to BPH Symptoms. Baseline through six months post-procedure 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.
Number of Participants With ER Visits, Hospital Admissions, and Surgical Re-treatments for Treatment-related Adverse Events Up to 90 Days Post-Procedure 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 procedureAssess the Occurrence of Surgical Retreatment for BPH in GreenLight XPS Patients. Procedure through five years post-procedure. Number of surgical re-treatment for BPH as a result of prostate tissue regrowth or insufficient prostatic tissue removal.
Assess Changes in Objective Measures of Urologic Function Baseline through six months post-procedure Changes in objective measures of urologic function from baseline through six months post-procedure using post void residual
Characteristics of the Study Procedure Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days. Summary of the study procedure, including length of procedure and lasing time
Characteristics of the Study Procedure and Immediate Outcomes Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days. Summarize characteristics of the study procedure and immediate outcomes: length of catheterization
Trial Locations
- Locations (6)
University of Montreal Hospital Center
🇨🇦Montreal, Quebec, Canada
El Camino Urology Medical Group, Inc.
🇺🇸Mountain View, California, United States
Houston Metro Urology
🇺🇸Houston, Texas, United States
Urology of Virginia, PLLC
🇺🇸Virginia Beach, Virginia, United States
Affiliates Division, Comprehensive Urology
🇺🇸Westland, Michigan, United States
Georgia Urology
🇺🇸Atlanta, Georgia, United States