Assessing the Impact of the PVP With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound

Study Overview
=================
Brief Summary
-----------------
The PVP by Greenlight laser 180W is becoming a potential therapeutic alternative in the treatment of benign prostatic hypertrophy (BPH) as recommended. The PVP creates a prostatic box after the vaporization of the prostatic tissue of BPH. The underlying prostatic tissue is the site of an ischemic necrosis secondary to the thermal effects of proximity of the PVP. We intend to measure by prostatic MRI and contrast-enhanced ultrasound the necrosis.

Detailed Description
-----------------
The laser PVP with an optical fiber firing side carries out a vaporization of next prostatic tissue and a necrosis of underlying prostatic tissue which corresponds to a postoperative inflammatory area. One of the side effects of this technique is the irritative syndrome which may involve urinary frequency, urgency or burning urination in approximately 10 to 20% at 1 month. The current literature does report neither the analysis of the underlying inflammatory necrotic area in prostatic vaporized tissue, nor the analysis of the urinary irritative signs post-laser PVP. Progresses in the field of functional ultrasound imaging allow us to consider a study of evolution of the underlying necrotic area devoid of micro-vascularisation under effect of PVP laser. The parallel with results of MRI (radiological technique most referenced) during the same period would help to support the experimental results of prostatic contrast-enhanced ultrasound.

Official Title
-----------------
Assessing the Impact of the Prostatic Photo-vaporization (PVP) With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound

Conditions
-----------------
Prostatic Hypertrophy, Benign

Intervention / Treatment
-----------------
* Device: prostatic photo-vaporization (PVP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 40 years old without an upper age limit Informed orally and in writing, having signed a consent which match to the research Patient with a benign prostatic hypertrophy requiring surgical treatment by PVP Person affiliated to a social security system Exclusion Criteria: Contraindications to MRI for patients with: ocular metallic foreign object any electronic medical device implanted by irremovable way (pacemakers, neuro-stimulator, cochlear implants ...) metallic heart valve, old heart valves are specially an absolute contraindication because of risk of dysfunction vascular clips implanted formerly on brain aneurysm Allergy to Gadolinium Contraindications to the contrast medium Sonovue: Hypersensitivity to hexafluorinated sulphur or any other components of Sonovue Recent acute coronary syndrome (within 6 months before the intervention) Unstable ischemic heart disease (myocardial infarction being formed or evolving, typical angina of rest in the previous month) Significant worsening of cardiac symptoms between the pre anaesthesia consultation and intervention Recent intervention (less than 6 months) on coronary arteries or other factor suggesting clinical instability (changes in ECG, changes in clinical or biological parameters) Acute heart failure or heart failure stage III or IV Severe arrhythmias Right-left shunt Acute endocarditis Valve prothesis Severe pulmonary hypertension (pulmonary artery pressure > 90mmHg) Systemic hypertension uncontrolled Respiratory distress syndrome Prostatic biopsy < 30 days or anal pathology Patient with prostate cancer Patient with a urinary infection Patient with preoperative urinary catheter Patient with a contraindication for surgery Adult patient with a legal protection measure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prostatic photo-vaporization<br>prostatic photo-vaporization (PVP) surgery with laser Greenlight | Device: prostatic photo-vaporization (PVP)<br>* Prostatic photo-vaporization using a lithium laser of 532nm wavelength (GREEN-LIGHT XPS™,American Medical Systems, Minnetonka, MN, USA) emitting by a fiber MoXy™ a maximum power of 180 W continuously. Using common practice and according to the CE labelling.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of thickness of the average necrotic area | The primary outcome measure is the measurement of the thickness of the average necrotic area in millimeters on prostatic monitoring MRI and contrast-enhanced ultrasound (no hypothesis in this descriptive study). The variables will be collected immediately after surgery as well as M1, M6 and M12. | J0 (immediately after surgery) M1, M6 and M12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of urinary irritative signs over 12 months | Evolution of urinary irritative signs over 12 months (prostatic monitoring MRI and contrast-enhanced ultrasound): score of IPSS questionary, results of the examination (binary variable) | J0, M1, M6 and M12 | 
| Evolution of prostatic volume over 12 months | Evolution of prostatic volume over 12 months (prostatic monitoring MRI and contrast-enhanced ultrasound) | J0, M1, M6 and M12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostatic Hypertrophy, Benign, Greenlight laser, Prostatic photovaporization, Prostatic MRI, Prostatic contrast-enhanced ultrasound, Urinary irritative signs, Postoperative necrotic area