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

Study Overview
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Brief Summary
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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.

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

Conditions
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BPH, Prostate Hyperplasia, Urinary Frequency/Urgency

Intervention / Treatment
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* Device: MRI Guided Transrectal Periuretheral Transitional Zone Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of lower urinary track symptoms (LUTS). Prostate volume of 40 - 200 cc. Men ≥ 45 years old. IPSS ≥ 15. BPH Impact Index ≥ 5. Exclusion Criteria: 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. Life expectancy of less than two years. Unable or unwilling to complete all required questionnaires and follow-up assessments.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLA for BPH Active Treatment<br> | Device: MRI Guided Transrectal Periuretheral Transitional Zone Ablation<br>* Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.<br>* Other names: Visualase;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) Change |  | Time Frame: Baseline, 2 months, 4 months, 6 months and 24 months | 
| International Prostate Symptom Score Quality of Life Question Change |  | Time Frame: Baseline, 2 months, 4 months, 6 months and 24 months | 
| BPH Impact Index Change |  | Time Frame: Baseline, 2 months, 4 months, 6 months and 24 months | 
| Sexual Health Inventory of Men (SHIM) Score Change |  | Time Frame: Baseline, 2 months, 4 months, 6 months and 24 months | 
| Number and severity of adverse events |  | Continuous until completion of the study at 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH, Benign Prostatic Hypertrophy, MRI, Prostate, Lower Urinary Tract Symptoms, Nocturia, Incomplete bladder emptying