Prostatic Hypertrophy, Benign Clinical Trial
Official title:
Assessing the Impact of the Prostatic Photo-vaporization (PVP) With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound
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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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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