Benign Prostatic Hyperplasia (BPH)Phase 4NCT01500057

Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia

A Phase 4 study testing Greenlight XPS Laser and BiVAP Saline Vaporization of the prostate in people with Benign Prostatic Hyperplasia (BPH), run by Brooklyn Urology Research Group at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Benign Prostatic Hyperplasia (BPH)
What is being tested?: Greenlight XPS Laser and BiVAP Saline Vaporization of the prostate
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteUnited States
Study dates: Dec 2011to 10 Oct 2016
Phase: Phase 4
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 18 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

male over the age of 18 years
present with symptomatic/ obstructive symptoms secondary to PBH requiring surgical intervention
subjects must read, understand and sign the Informed Consent
AUA ≥ 15
Qmax < 15mL/sec
Stopped BPH medication. Alpha blockers 15 days 5-α-reductase 3 months
Prostate volume ≥ 30g

Who cannot join

PVR > 300ml
Current urine retention
Previous surgical or invasive treatments (TURP, TUMT, TUNA)
PSA ≥ 4 (must have negative biopsy within last 12 months)
Neurogenic bladder
Obstruction due to urethral stricture
Any disorder or condition of the subject that the investigator believes will counter indicate their inclusion in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Brooklyn Urology Research Group
Brooklyn, New York, 11215

Other trials in United States

About this study

Official title: An Open-Label Randomized Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia

This is a Phase 4, prospective, open-label, randomized study of Greenlight XPS Laser versus BiVAP Saline Vaporization of the prostate in men with symptomatic Benign Prostatic Hyperplasia (BPH). The study consists of a screening phase, treatment, followed by follow-up visits at 1 week, 4 weeks, 3 months, 6 months, and 12 months.

Conditions: Benign Prostatic Hyperplasia (BPH)
Being tested: Greenlight XPS Laser, BiVAP Saline Vaporization of the prostate
Keywords: enlarged prostate
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 LaserDevice
Treatment of BPH with Greenlight XPS laser
BiVAP Saline Vaporization of the prostateDevice
treatment of BPH with BiVAP Saline Vaporization

Study groups in NCT01500057
Study group	Role	What they receive
Greenlight XPS Laser	Active comparator	Greenlight XPS Laser of the prostate Receives: Device: Greenlight XPS Laser
BiVAP Saline Vaporization	Active comparator	BiVAP Saline Vaporization of the prostate Receives: Device: BiVAP Saline Vaporization of the prostate

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in American Urological Association Symptom Score
The American Urological Association Symptom Score range is 0-35 with 35 being the most severe urinary symptoms
Measured: Baseline and 12 months
Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax)
maximum urinary flow rate was measures using uroflow device
Measured: baseline and 12 months

Secondary outcomes (1)

Change From Baseline to 12 Months in Post Void Residual Volume
post void residual was measured using a bladder scan device
Measured: baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201110 Oct 2016

First posted26 Dec 2011 (estimated)
Study startDec 2011
Primary completion10 Oct 2016
Study completion10 Oct 2016

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 Hyperplasia (BPH)Studies of the same condition, open and under way.
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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01500057
Sponsor's protocol ID: WIRB Protocol# 20111638
Status last verified: Apr 2018
First submitted: 16 Dec 2011
Last updated: 14 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Benign Prostatic Hyperplasia (BPH) trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Randomized Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT01500057
Acronym / sponsor ID: WIRB Protocol# 20111638
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: enlarged prostate
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Brooklyn Urology Research GroupUniversity, hospital or other
Collaborators: American Medical Systems, Richard Wolf Medical Instruments Corporation (RWMIC)
Study start: Dec 2011
Primary completion: 10 Oct 2016 (actual)
Study completion: 10 Oct 2016 (actual)
First posted: 26 Dec 2011 (estimated)
Results: Posted 14 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Greenlight XPS Laser	Active comparator	Device: Greenlight XPS LaserGreenlight XPS Laser of the prostate
BiVAP Saline Vaporization	Active comparator	Device: BiVAP Saline Vaporization of the prostateBiVAP Saline Vaporization of the prostate

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

male over the age of 18 years
present with symptomatic/ obstructive symptoms secondary to PBH requiring surgical intervention
subjects must read, understand and sign the Informed Consent
AUA ≥ 15
Qmax < 15mL/sec

Key exclusion criteria (7 listed)

PVR > 300ml
Current urine retention
Previous surgical or invasive treatments (TURP, TUMT, TUNA)
PSA ≥ 4 (must have negative biopsy within last 12 months)
Neurogenic bladder

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 LaserTreatment of BPH with Greenlight XPS laser	Device	Greenlight XPS Laser
BiVAP Saline Vaporization of the prostatetreatment of BPH with BiVAP Saline Vaporization	Device	BiVAP Saline Vaporization

Primary outcome

Change From Baseline in American Urological Association Symptom Score
Time frame: Baseline and 12 months
The American Urological Association Symptom Score range is 0-35 with 35 being the most severe urinary symptoms
Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax)
Time frame: baseline and 12 months
maximum urinary flow rate was measures using uroflow device

1 secondary outcome

Change From Baseline to 12 Months in Post Void Residual Volume
Time frame: baseline and 12 months

Results and safety

Results posted to the registry on 14 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Greenlight XPS Laser	31	25
BiVAP Saline Vaporization	35	31

Primary outcome: Change From Baseline in American Urological Association Symptom Score

Time frame: Baseline and 12 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Greenlight XPS Laser n = 23	BiVAP Saline Vaporization n = 27
Value	-14.7 (9.0)	-10.5 (8.6)

Population analysed: All people who completed the study and had data available

Primary outcome: Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax)

Time frame: baseline and 12 months. Mean (Standard Deviation). Unit: ml/sec

Measure	Greenlight XPS Laser n = 23	BiVAP Saline Vaporization n = 24
Value	5.9 (8.6)	2.3 (8.3)

Population analysed: all participants who completed the study and have available data

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Greenlight XPS Laser	0 of 31 (0%)	2 of 31 (6.5%)	0 of 31
BiVAP Saline Vaporization	0 of 35 (0%)	4 of 35 (11.4%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Benign Prostatic Hyperplasia (BPH)

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 7 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 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2018). 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?

Change From Baseline in American Urological Association Symptom Score (time frame: Baseline and 12 months). 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?

On the ClinicalTrials.gov record for NCT01500057.

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 14 May 2018.