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GreenLight XPS Laser System Retrospective Chart Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139969
Recruitment Status : Completed
First Posted : May 16, 2014
Results First Posted : November 9, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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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.

Condition or disease Intervention/treatment
Benign Prostatic Hyperplasia 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 Design
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Study Type : Observational
Actual Enrollment : 956 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Study Start Date : May 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

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Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. International Prostate Symptom Score (IPSS) [ Time Frame: 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.

  2. Occurrence of Adverse Events Related to the Study Treatment. [ Time Frame: 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 :
  1. Characteristics of the Study Procedure [ Time Frame: 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

  2. Characteristics of the Study Procedure and Immediate Outcomes [ Time Frame: Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days. ]
    Summary of characteristics of the study procedure and immediate outcomes: total energy used (kJ)

  3. Assess Changes in Quality of Life Related to BPH Symptoms. [ Time Frame: 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.

  4. Assess Changes in Objective Measures of Urologic Function. [ Time Frame: Baseline through six months post-procedure. ]
    Changes in objective measures of urologic function from baseline through six months post-procedure using Peak Flow Rate (Qmax)

  5. Number of Participants With ER Visits, Hospital Admissions, and Surgical Re-treatments for Treatment-related Adverse Events Up to 90 Days Post-Procedure [ Time Frame: 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

  6. Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence [ Time Frame: 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.

  7. Assess the Occurrence of Surgical Retreatment for BPH in GreenLight XPS Patients. [ Time Frame: 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.

  8. Characteristics of the Study Procedure and Immediate Outcomes [ Time Frame: 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

  9. Length of Hospital Stay [ Time Frame: 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

  10. Type of Hospital Stay [ Time Frame: 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)

  11. Number of Participants Stratified by Number of Fibers Used During Procedure [ Time Frame: 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

  12. Assess Changes in Objective Measures of Urologic Function [ Time Frame: Baseline through six months post-procedure ]
    Changes in objective measures of urologic function from baseline through six months post-procedure using post void residual

  13. Changes in Objective Measures of Urologic Function [ Time Frame: Baseline through six months post-procedure. ]
    Changes in objective measures of urologic function from baseline through six months post-procedure using prostate volume

  14. Assess Changes in Objective Measures of Urologic Function. [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139969


Locations
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United States, California
El Camino Urology Medical Group, Inc.
Mountain View, California, United States, 94040
United States, Georgia
Georgia Urology
Atlanta, Georgia, United States, 30308
United States, Michigan
Affiliates Division, Comprehensive Urology
Westland, Michigan, United States, 48186
United States, Texas
Houston Metro Urology
Houston, Texas, United States, 77027
United States, Virginia
Urology of Virginia, PLLC
Virginia Beach, Virginia, United States, 23462
Canada, Quebec
University of Montreal Hospital Center
Montreal, Quebec, Canada
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Mahmood A. Hai, M.D. Affiliates Division, Comprehensive Urology
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02139969    
Other Study ID Numbers: PE1401
First Posted: May 16, 2014    Key Record Dates
Results First Posted: November 9, 2020
Last Update Posted: November 9, 2020
Last Verified: January 2018
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases