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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prostatic photo-vaporization | Experimental | prostatic photo-vaporization (PVP) surgery with laser Greenlight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prostatic photo-vaporization (PVP) | Device | Prostatic photo-vaporization using a lithium laser of 532nm wavelength (GREEN-LIGHT XPSâ„¢,American Medical Systems, Minnetonka, MN, USA) emitting by a fiber MoXyâ„¢ a maximum power of 180 W continuously. Using common practice and according to the CE labelling. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications to MRI for patients with:
Allergy to Gadolinium
Contraindications to the contrast medium Sonovue:
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
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| Name | Affiliation | Role |
|---|---|---|
| Franck BRUYERE, MD | CHRU TOURS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chru Tours | Tours | 37044 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23837622 | Result | Bruyere F, Bodin T, Bleuzen A, Patat F, Brunereau L. Penetration depth with the XPS GreenLight laser assessed by contrast enhanced ultrasonography. J Endourol. 2013 Oct;27(10):1282-6. doi: 10.1089/end.2013.0368. Epub 2013 Aug 21. |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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|
Evolution of prostatic volume over 12 months (prostatic monitoring MRI and contrast-enhanced ultrasound) |
| J0, M1, M6 and M12 |
| D052801 |
| Male Urogenital Diseases |