Treatment of Benign Prostatic HyperplasiaNCT02683980
Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH
A study testing Lumenis Pulse P120H and Xpeeda side firing fiber in people with Treatment of Benign Prostatic Hyperplasia, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
Twenty (20) subjects presenting with a hyperplasia enlarged prostate and candidates for surgery will undergo a single treatment for ablation of the prostate using the study device. Follow up visits are scheduled for the day of release from the hospital and at 1 and 3 months post procedure. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Treatment of Benign Prostatic Hyperplasia
- What is being tested?
- Lumenis Pulse P120H and Xpeeda side firing fiber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 1 Nov 2017
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject will be older than 18 years of age
- Subject was diagnosed with enlarged prostate of ≥ 30 gr volume
- Subject is a candidate for surgery treatment
- Subject is willing and has signed the Informed Consent Form
- AUA score ≥ 12
- Qmax <15 mL/s
Who cannot join
- Need to perform concomitant procedure, other than prostate vaporization
- PVR > 300 mL
- Current Urine retention and Pdet <40 cm H20
- Documented or suspected prostate cancer and / or bladder cancer
- Neurogenic bladder disorder / neurogenic voiding dysfunction
- Urethral strictures
Show all 12Show fewer
- Previous prostatic, bladder neck, or urethral surgery
- Known history of spinal cord injury
- Urogenital trauma
- Bladder neck stricture
- Evidence of urinary tract infection
- History of chronic prostatitis
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Methodist Hospital
New York, New York, 11215
About this study
Twenty (20) subjects presenting with a hyperplasia enlarged prostate and candidates for surgery will undergo a single treatment for ablation of the prostate using the study device. Follow up visits are scheduled for the day of release from the hospital and at 1 and 3 months post procedure.
The primary objective of this study is to explore Vaporization efficacy and safety when treating BPH (Benign prostatic hyperplasia) with the contact side firing fiber with recommended settings.
- Being tested
- Lumenis Pulse P120H and Xpeeda side firing fiber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumenis Pulse P120H and Xpeeda side firing fiberDevice
| Study group | Role | What they receive |
|---|---|---|
| Ablation of the prostate | Experimental | ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Receives: Device: Lumenis Pulse P120H and Xpeeda side firing fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ablation Time
Calculate the lasing time (in minutes) to ablate the prostate as an indication for treatment efficiency.
Measured: Intraprocedural (procedure time is typically 1 to 3 hours)
Ablation Rate
Ablation rate is the change in prostate volume measured by trans-rectal ultrasound divided by the procedure time.
Ablation rate= (baseline prostate volume - 3-Month prostate volume in mL) / Procedure time in minutes
Measured: Baseline and 3-month follow-up visit
Efficiency of the Laser to Ablate the Prostate
Ablation efficiency is the change in prostate volume, as measured by trans-urethral ultrasound, between baseline and the 3-month follow-up visit divided by energy.
Efficiency = (Baseline prostate volume in mL - prostate volume at the 3-month follow-up visit) / energy in J
Measured: Baseline and 3-month follow-up visit
Safety: Intraoperative Complications
Number and type of intraoperative complications
Measured: Intraoperative (procedure time is typically 1 to 3 hours)
Safety: Perioperative Complications
Number of Re-Catheterizations and number of Readmissions were evaluated within this Outcome Measure. Erectile Dysfunction is reported separately. Other complications with reporting of Level of Severity (mild, moderate, or severe) are listed as part of this Outcome Measure. These other complications were Bleeding, Dysuria, Hematuria, Urgency, Urinary Incontinence, Urinary Retention, Frequency, and Nocturia
Measured: Post-procedure through 3 months
Secondary outcomes (10)
Erectile Dysfunction
Sum score of International Index of Erectile Function (IIEF-5) questionnaire which measures erectile function, orgasmic function, sexual desire, and satisfaction. Each question is ranked 1-5 with a total sum score of 5 (severe erectile dysfunction) to 25 (normal function).
Measured: Baseline and 3-month follow-up visit
Visibility During Procedure
Rating on a scale of 1 (Poor) to 5 (Excellent) of the visibility during the procedure
Measured: Intraprocedural (procedure time is typically 1 to 3 hours)
Number of Fibers Used During Procedure
Number of fibers used during the BPH procedure
Measured: Intraprocedural (procedure time is typically 1 to 3 hours)
Catheterization Time
Number of days catheter was in place post-ablation of the prostate
Measured: Postoperatively through study completion up to 3 months
Hospital Stay Duration
Number of days in hospital
Measured: Procedure through discharge from hospital (typically 1 day, but measured through end of study up to 3 months)
International Prostate Symptom Score Quality of Life
The International Prostate Symptom Score (IPSS) is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the lower urinary tract symptoms of benign prostatic hyperplasia (BPH). The Quality of Life question has a scale of 0-6, with 0=delighted and 6=terrible.
Measured: Baseline, 1-month and 3-month follow-up visits
Qmax Uroflow
The maximum urine flow rate (Qmax) is a measure of the quantity of urine excreted in a specified period of time, expressed in cubic centimeters/second (cc/sec).
Measured: Baseline, 1-month and 3-month follow-up visits
PVR (Post-void Residual)
Volume of urine remaining in the bladder after voiding, measured via ultrasound
Measured: Baseline, 1-month and 3-month follow-up visits
PSA (Prostate-specific Antigen)
Prostate-specific antigen, or PSA, is a protein produced by cells of the prostate gland. Prostate cancer can cause elevated PSA levels.
Measured: Baseline and 3-month follow-up visit
Americal Urological Association (AUA) Symptom Index
The American Urological Association (AUA) Symptom Index assesses the severity of lower urinary tract symptoms in men, particularly related to benign prostatic hyperplasia. The AUA Symptom Score ranges from 0 to 35, with higher scores indicating more severe urinary symptoms related to benign prostatic hyperplasia (BPH).
Measured: Baseline, 1-month and 3-month follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
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 Treatment of 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lumenis Be Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683980
- Sponsor's protocol ID
- LUM-SBU-VP-15-02
- Status last verified
- Nov 2025
- First submitted
- 31 Jan 2016
- Last updated
- 25 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH
- ClinicalTrials.gov ID
- NCT02683980
- Acronym / sponsor ID
- LUM-SBU-VP-15-02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Lumenis Be Ltd.
- Study start
- Feb 2016 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Posted 25 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Twenty (20) subjects presenting with a hyperplasia enlarged prostate and candidates for surgery will undergo a single treatment for ablation of the prostate using the study device. Follow up visits are scheduled for the day of release from the hospital and at 1 and 3 months post procedure.
The primary objective of this study is to explore Vaporization efficacy and safety when treating BPH (Benign prostatic hyperplasia) with the contact side firing fiber with recommended settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation of the prostate | Experimental | Device: Lumenis Pulse P120H and Xpeeda side firing fiberablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject will be older than 18 years of age
- Subject was diagnosed with enlarged prostate of ≥ 30 gr volume
- Subject is a candidate for surgery treatment
- Subject is willing and has signed the Informed Consent Form
- AUA score ≥ 12
Key exclusion criteria (12 listed)
- Need to perform concomitant procedure, other than prostate vaporization
- PVR > 300 mL
- Current Urine retention and Pdet <40 cm H20
- Documented or suspected prostate cancer and / or bladder cancer
- Neurogenic bladder disorder / neurogenic voiding dysfunction
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 |
|---|---|---|
| Lumenis Pulse P120H and Xpeeda side firing fiber | Device | Ablation of the prostate |
Primary outcome
Ablation Time
Time frame: Intraprocedural (procedure time is typically 1 to 3 hours)
Calculate the lasing time (in minutes) to ablate the prostate as an indication for treatment efficiency.
Ablation Rate
Time frame: Baseline and 3-month follow-up visit
Ablation rate is the change in prostate volume measured by trans-rectal ultrasound divided by the procedure time. Ablation rate= (baseline prostate volume - 3-Month prostate volume in mL) / Procedure time in minutes
Efficiency of the Laser to Ablate the Prostate
Time frame: Baseline and 3-month follow-up visit
Ablation efficiency is the change in prostate volume, as measured by trans-urethral ultrasound, between baseline and the 3-month follow-up visit divided by energy. Efficiency = (Baseline prostate volume in mL - prostate volume at the 3-month follow-up visit) / energy in J
Safety: Intraoperative Complications
Time frame: Intraoperative (procedure time is typically 1 to 3 hours)
Number and type of intraoperative complications
Safety: Perioperative Complications
Time frame: Post-procedure through 3 months
Number of Re-Catheterizations and number of Readmissions were evaluated within this Outcome Measure. Erectile Dysfunction is reported separately. Other complications with reporting of Level of Severity (mild, moderate, or severe) are listed as part of this Outcome Measure. These other complications were Bleeding, Dysuria, Hematuria, Urgency, Urinary Incontinence, Urinary Retention, Frequency, and Nocturia
10 secondary outcomes
Erectile Dysfunction
Time frame: Baseline and 3-month follow-up visit
Visibility During Procedure
Time frame: Intraprocedural (procedure time is typically 1 to 3 hours)
Number of Fibers Used During Procedure
Time frame: Intraprocedural (procedure time is typically 1 to 3 hours)
Catheterization Time
Time frame: Postoperatively through study completion up to 3 months
Hospital Stay Duration
Time frame: Procedure through discharge from hospital (typically 1 day, but measured through end of study up to 3 months)
International Prostate Symptom Score Quality of Life
Time frame: Baseline, 1-month and 3-month follow-up visits
Qmax Uroflow
Time frame: Baseline, 1-month and 3-month follow-up visits
PVR (Post-void Residual)
Time frame: Baseline, 1-month and 3-month follow-up visits
PSA (Prostate-specific Antigen)
Time frame: Baseline and 3-month follow-up visit
Americal Urological Association (AUA) Symptom Index
Time frame: Baseline, 1-month and 3-month follow-up visits
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- 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.
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?
A study testing Lumenis Pulse P120H and Xpeeda side firing fiber in people with Treatment of Benign Prostatic Hyperplasia, run by Boston Scientific Corporation at 1 site in United States.
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 6 inclusion and 12 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 25 Nov 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2025). 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?
Ablation Time (time frame: Intraprocedural (procedure time is typically 1 to 3 hours)). The study lists 5 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 25 Nov 2025.