BPHNCT03131544

MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)

A study testing MRI Guided Transrectal Periuretheral Transitional Zone Ablation in people with BPH and Prostate Hyperplasia, run by Prostate Laser Center, PLLC 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 45 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: BPH, Prostate Hyperplasia, Urinary Frequency/Urgency
What is being tested?: MRI Guided Transrectal Periuretheral Transitional Zone Ablation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 17 Apr 2017to 15 May 2020
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 45 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Diagnosis of lower urinary track symptoms (LUTS).
Prostate volume of 40 - 200 cc.
Men ≥ 45 years old.
IPSS ≥ 15.
BPH Impact Index ≥ 5.

Who cannot join

History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, or findings suggestive of likely underlying prostate cancer.
Need to catheterize to relieve obstruction.
Daily use of incontinence materials/padding.
Neurogenic or hypotonic bladder, Parkinson's Disease, or a history of uncontrolled diabetes.
Prior interventional or surgical treatment of BPH.
Penile prosthesis.

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Artificial urinary sphincter or collagen bladder injection.
Urethral stricture.
Bleeding disorder/coagulopathy.
Inability to refrain from blood thinners in the peri-procedural period.
Inability or chooses not to provide informed consent.
Any serious medical condition which would make proceeding to treatment unsafe.
Significant contraindication to MRI or gadolinium contrast.
Hip replacement.
Lack of a rectum.
Life expectancy of less than two years.
Unable or unwilling to complete all required questionnaires and follow-up assessments.

Trial locations and contacts

1 site in 1 country.

United States1 site

Prostate Laser Center, PLLC
Houston, Texas, 77030

Other trials in United States

About this study

Over 100,000 BPH procedures are performed annually in the US. The purpose of this study is to evaluate the effectiveness of performing MRI guided transrectal laser ablation using a 980 nm laser (VisualaseTM by Medtronic, Inc., a Minnesota, U.S.A. company) to treat benign prostatic hypertrophy (BPH). The laser system will be used to necrotize urological soft tissue within the prostate under MRI guidance. This will be a single center, single arm prospective trial with an anticipated enrollment of 10 men. Patients who elect this treatment option and choose to be part of the study will be enrolled consecutively.

Conditions: BPH, Prostate Hyperplasia, Urinary Frequency/Urgency
Being tested: MRI Guided Transrectal Periuretheral Transitional Zone Ablation
Keywords: BPH, Benign Prostatic Hypertrophy, MRI, Prostate, Lower Urinary Tract Symptoms, Nocturia, Incomplete bladder emptying
Medical subject headings: Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Nocturia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MRI Guided Transrectal Periuretheral Transitional Zone AblationDevice
Also called Visualase
Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.

Study groups in NCT03131544
Study group	Role	What they receive
FLA for BPH Active Treatment	Experimental	Not described Receives: Device: MRI Guided Transrectal Periuretheral Transitional Zone Ablation

What is being measured

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

International Prostate Symptom Score (IPSS) Change
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
Measured: From baseline to 2 months
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")
Measured: From baseline to 2 months
BPH Impact Index Change
This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)
Measured: From baseline to 2 months
Sexual Health Inventory of Men (SHIM) Score Change
This survey rates erectile function from 0 (no function) to 25 (full function)
Measured: From baseline to 2 months
Number of Adverse Events
We asked patients to self-report adverse events.
Measured: Continuous until completion of the study at 2 years
International Prostate Symptom Score (IPSS) Change
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
Measured: From baseline to 4 months
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")
Measured: From baseline to 4 months
BPH Impact Index Change
This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)
Measured: From baseline to 4 months
Sexual Health Inventory of Men (SHIM) Score Change
This survey rates erectile function from 0 (no function) to 25 (full function)
Measured: From baseline to 4 months
International Prostate Symptom Score (IPSS) Change
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
Measured: From baseline to 6 months
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")
Measured: From baseline to 6 months
BPH Impact Index Change
This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)
Measured: From baseline to 6 months
Sexual Health Inventory of Men (SHIM) Score Change
This survey rates erectile function from 0 (no function) to 25 (full function)
Measured: From baseline to 6 months
International Prostate Symptom Score (IPSS) Change
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
Measured: From baseline to 24 months
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")
Measured: From baseline to 24 months
BPH Impact Index Change
This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)
Measured: From baseline to 24 months
Sexual Health Inventory of Men (SHIM) Score Change
This survey rates erectile function from 0 (no function) to 25 (full function)
Measured: From baseline to 24 months

Timeline

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

17 Apr 201715 May 2020

First posted27 Apr 2017
Study start17 Apr 2017
Primary completion15 Oct 2018
Study completion15 May 2020

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for BPHStudies 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03131544
Sponsor's protocol ID: Prostate Laser Center BPH 01
Status last verified: Apr 2024
First submitted: 16 Apr 2017
Last updated: 25 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Harman AL, Toth R, Karamanian A. Magnetic Resonance Imaging-Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hyperplasia. J Vasc Interv Radiol. 2023 Nov;34(11):2024-2028. doi: 10.1016/j.jvir.2023.07.015. Epub 2023 Jul 21. No abstract available.
PubMed 37481065

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

Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruitingPhase 3
Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Perioperative Parameter and Treatment Outcomes of Surgical Treatment for Benign Prostate Hyperplasia in Hong Kong
Benign Prostatic Hyperplasia

All BPH trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)
ClinicalTrials.gov ID: NCT03131544
Acronym / sponsor ID: Prostate Laser Center BPH 01
Conditions: BPH, Prostate Hyperplasia, Urinary Frequency/Urgency
Keywords: BPH, Benign Prostatic Hypertrophy, MRI, Prostate, Lower Urinary Tract Symptoms, Nocturia, Incomplete bladder emptying
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Prostate Laser Center, PLLCIndustry (pharma, biotech, devices)
Collaborators: Medtronic
Study start: 17 Apr 2017 (actual)
Primary completion: 15 Oct 2018 (actual)
Study completion: 15 May 2020 (actual)
First posted: 27 Apr 2017 (actual)
Results: Posted 25 Apr 2024

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
FLA for BPH Active Treatment	Experimental	Device: MRI Guided Transrectal Periuretheral Transitional Zone Ablation

Who may qualify

Ages: 45 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of lower urinary track symptoms (LUTS).
Prostate volume of 40 - 200 cc.
Men ≥ 45 years old.
IPSS ≥ 15.
BPH Impact Index ≥ 5.

Key exclusion criteria (17 listed)

History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, or findings suggestive of likely underlying prostate cancer.
Need to catheterize to relieve obstruction.
Daily use of incontinence materials/padding.
Neurogenic or hypotonic bladder, Parkinson's Disease, or a history of uncontrolled diabetes.
Prior interventional or surgical treatment of BPH.

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
MRI Guided Transrectal Periuretheral Transitional Zone AblationAlso: VisualasePatients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.	Device	FLA for BPH Active Treatment

Primary outcome

International Prostate Symptom Score (IPSS) Change
Time frame: From baseline to 2 months
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
Time frame: From baseline to 2 months
The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")
BPH Impact Index Change
Time frame: From baseline to 2 months
This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)
Sexual Health Inventory of Men (SHIM) Score Change
Time frame: From baseline to 2 months
This survey rates erectile function from 0 (no function) to 25 (full function)
Number of Adverse Events
Time frame: Continuous until completion of the study at 2 years
We asked patients to self-report adverse events.
International Prostate Symptom Score (IPSS) Change
Time frame: From baseline to 4 months
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
Time frame: From baseline to 4 months
The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")
BPH Impact Index Change
Time frame: From baseline to 4 months
This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)
Sexual Health Inventory of Men (SHIM) Score Change
Time frame: From baseline to 4 months
This survey rates erectile function from 0 (no function) to 25 (full function)
International Prostate Symptom Score (IPSS) Change
Time frame: From baseline to 6 months
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
Time frame: From baseline to 6 months
The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")
BPH Impact Index Change
Time frame: From baseline to 6 months
This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)
Sexual Health Inventory of Men (SHIM) Score Change
Time frame: From baseline to 6 months
This survey rates erectile function from 0 (no function) to 25 (full function)
International Prostate Symptom Score (IPSS) Change
Time frame: From baseline to 24 months
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
Time frame: From baseline to 24 months
The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")
BPH Impact Index Change
Time frame: From baseline to 24 months
This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)
Sexual Health Inventory of Men (SHIM) Score Change
Time frame: From baseline to 24 months
This survey rates erectile function from 0 (no function) to 25 (full function)

Results and safety

Results posted to the registry on 25 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Focal Laser Ablation (FLA) for BPH Active Treatment	10	9

Primary outcome: International Prostate Symptom Score (IPSS) Change

Time frame: From baseline to 2 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n = 10
Value	-17.5 (4.3)

Primary outcome: International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change

Time frame: From baseline to 2 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n = 10
Value	-3.4 (0.8)

Primary outcome: BPH Impact Index Change

Time frame: From baseline to 2 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n = 10
Value	-6.9 (2.1)

Primary outcome: Sexual Health Inventory of Men (SHIM) Score Change

Time frame: From baseline to 2 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n = 10
Value	1.9 (2.7)

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FLA for BPH Active Treatment	0 of 10 (0%)	4 of 10 (40%)	0 of 10

Limitations and caveats (from the sponsor): One patient dropped out after 6 month because his symptoms returned and he underwent a TURP.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37481065Harman AL, Toth R, Karamanian A. Magnetic Resonance Imaging-Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hyperplasia. J Vasc Interv Radiol. 2023 Nov;34(11):2024-2028. doi: 10.1016/j.jvir.2023.07.015. Epub 2023 Jul 21. No abstract available.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for BPH

Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruitingPhase 3
Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
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Recruiting
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RecruitingObservational study
Perioperative Parameter and Treatment Outcomes of Surgical Treatment for Benign Prostate Hyperplasia in Hong Kong
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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 MRI Guided Transrectal Periuretheral Transitional Zone Ablation in people with BPH and Prostate Hyperplasia, run by Prostate Laser Center, PLLC 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 5 inclusion and 17 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 Apr 2024. 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 Apr 2024). 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) Change (time frame: From baseline to 2 months). The study lists 17 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 NCT03131544, which also lists 1 linked publication.

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 Apr 2024.