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Completed

NCT Number: NCT02139969

GreenLight XPS Laser System Retrospective Chart Review

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Sex eligibility

Male

Study type

Observational

Primary location

University of Montreal Hospital Center, Montreal, Quebec, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GreenLight XPS Laser System

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 16, 2014
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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