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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
Prostate Laser Center, PLLC
Houston, Texas, United States
International Prostate Symptom Score (IPSS) Change
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
Time frame: 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")
Time frame: 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)
Time frame: 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)
Time frame: From baseline to 2 months
Number of Adverse Events
We asked patients to self-report adverse events.
Time frame: 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).
Time frame: 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")
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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")
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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")
Time frame: 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)
Time frame: 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)
Time frame: From baseline to 24 months
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