Benign Prostatic HyperplasiaNCT02139969
GreenLight XPS Laser System Retrospective Chart Review
An observational study of Benign Prostatic Hyperplasia, run by Boston Scientific Corporation at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- GreenLight XPS Laser System
- Type of treatment
- Medical device
- How many people
- 956 participants
- Where
- 6 sitesin 2 countries
- Study dates
- May 2014to Nov 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Men who have had a GreenLight XPS procedure with a MoXy Fiber since 01-Aug-2010.
Who cannot join
- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Georgia Urology
Atlanta, Georgia, 30308
Houston Metro Urology
Houston, Texas, 77027
El Camino Urology Medical Group, Inc.
Mountain View, California, 94040
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462
Affiliates Division, Comprehensive Urology
Westland, Michigan, 48186
About this study
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
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.
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- GreenLight XPS Laser System
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GreenLight XPS Laser SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| GreenLight XPS Laser System | Treatment of BPH in men using the GreenLight XPS Laser System and the MoXy fiber Receives: Device: GreenLight XPS Laser System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 365 Days
Secondary outcomes (14)
Characteristics of the Study Procedure
Summary of the study procedure, including length of procedure and lasing time
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From baseline through six months post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 956 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahmood A. Hai, M.D., Principal investigator, Affiliates Division, Comprehensive Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139969
- Sponsor's protocol ID
- PE1401
- Status last verified
- Jan 2018
- First submitted
- 13 May 2014
- Last updated
- 9 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02139969
- Acronym / sponsor ID
- PE1401
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 956 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Posted 9 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GreenLight XPS Laser System | – | Device: GreenLight XPS Laser SystemTreatment of BPH in men using the GreenLight XPS Laser System and the MoXy fiber |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Men who have had a GreenLight XPS procedure with a MoXy Fiber since 01-Aug-2010.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GreenLight XPS Laser System | Device | GreenLight XPS Laser System |
Primary outcome
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.
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.
14 secondary outcomes
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.
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.
Assess Changes in Quality of Life Related to BPH Symptoms.
Time frame: Baseline through six months post-procedure
Assess Changes in Objective Measures of Urologic Function.
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
Time frame: Up to 90 days post-procedure.
Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence
Time frame: 90 days, 180 days
Assess the Occurrence of Surgical Retreatment for BPH in GreenLight XPS Patients.
Time frame: Procedure through five years post-procedure.
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.
Length of Hospital Stay
Time frame: The number of days from admission through discharge from the medical facility will be measured.
Type of Hospital 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
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
Time frame: Baseline through six months post-procedure
Changes in Objective Measures of Urologic Function
Time frame: Baseline through six months post-procedure.
Assess Changes in Objective Measures of Urologic Function.
Time frame: From baseline through six months post-procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmood A. Hai, M.D. principal investigator
Affiliates Division, Comprehensive Urology
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia, run by Boston Scientific Corporation at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score (IPSS) (time frame: 6 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.