Clinical trial NCT01732991: Assessing the Impact of the PVP With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound
Official title: Assessing the Impact of the Prostatic Photo-vaporization (PVP) With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Hypertrophy, Benign
Keywords: Prostatic Hypertrophy, Benign
Greenlight laser
Prostatic photovaporization
Prostatic MRI
Prostatic contrast-enhanced ultrasound
Urinary irritative signs
Postoperative necrotic area
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2012-11-26
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Evolution of thickness of the average necrotic area
timeFrame: J0 (immediately after surgery) M1, M6 and M12
Secondary outcomes:
measure: Evolution of urinary irritative signs over 12 months
timeFrame: J0, M1, M6 and M12
measure: Evolution of prostatic volume over 12 months
timeFrame: J0, M1, M6 and M12
Other outcomes:
Locations:
city: Tours
country: France
facility: Chru Tours
Study officials:
affiliation: CHRU TOURS
name: Franck BRUYERE, MD
role: PRINCIPAL_INVESTIGATOR
References: