MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)
1 other identifier
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2017
CompletedStudy Start
First participant enrolled
April 17, 2017
CompletedFirst Posted
Study publicly available on registry
April 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2020
CompletedResults Posted
Study results publicly available
April 25, 2024
CompletedApril 25, 2024
April 1, 2024
1.5 years
April 16, 2017
January 29, 2024
April 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (17)
International Prostate Symptom Score (IPSS) Change
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
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")
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)
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)
From baseline to 2 months
Number of Adverse Events
We asked patients to self-report adverse events.
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).
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")
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)
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)
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).
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")
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)
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)
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).
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")
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)
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)
From baseline to 24 months
Study Arms (1)
FLA for BPH Active Treatment
EXPERIMENTALInterventions
Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
Eligibility Criteria
You may qualify if:
- Diagnosis of lower urinary track symptoms (LUTS).
- Prostate volume of 40 - 200 cc.
- Men ≥ 45 years old.
- IPSS ≥ 15.
- BPH Impact Index ≥ 5.
You may not qualify if:
- 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.
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prostate Laser Center, PLLClead
- Medtroniccollaborator
Study Sites (1)
Prostate Laser Center, PLLC
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 37481065DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
One patient dropped out after 6 month because his symptoms returned and he underwent a TURP.
Results Point of Contact
- Title
- Dr. Ara Karamanian, Medical Director of the Prostate Program
- Organization
- Prostate Laser Center, PLLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2017
First Posted
April 27, 2017
Study Start
April 17, 2017
Primary Completion
October 15, 2018
Study Completion
May 15, 2020
Last Updated
April 25, 2024
Results First Posted
April 25, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share