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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01732991
Recruitment Status : Completed
First Posted : November 26, 2012
Last Update Posted : September 1, 2015
Information provided by (Responsible Party):
University Hospital, Tours

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.

Condition or disease Intervention/treatment Phase
Prostatic Hypertrophy, Benign Device: prostatic photo-vaporization (PVP) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing the Impact of the Prostatic Photo-vaporization (PVP) With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound
Study Start Date : September 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: prostatic photo-vaporization
prostatic photo-vaporization (PVP) surgery with laser Greenlight
Device: prostatic photo-vaporization (PVP)
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.

Primary Outcome Measures :
  1. Evolution of thickness of the average necrotic area [ Time Frame: J0 (immediately after surgery) M1, M6 and M12 ]
    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.

Secondary Outcome Measures :
  1. Evolution of urinary irritative signs over 12 months [ Time Frame: J0, M1, M6 and M12 ]
    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)

  2. Evolution of prostatic volume over 12 months [ Time Frame: J0, M1, M6 and M12 ]
    Evolution of prostatic volume over 12 months (prostatic monitoring MRI and contrast-enhanced ultrasound)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01732991

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Chru Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
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Principal Investigator: Franck BRUYERE, MD CHRU TOURS
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Responsible Party: University Hospital, Tours Identifier: NCT01732991    
Other Study ID Numbers: PHAO 2012 - FB / PROPIL
First Posted: November 26, 2012    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015
Keywords provided by University Hospital, Tours:
Prostatic Hypertrophy, Benign
Greenlight laser
Prostatic photovaporization
Prostatic MRI
Prostatic contrast-enhanced ultrasound
Urinary irritative signs
Postoperative necrotic area
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Pathological Conditions, Anatomical
Prostatic Diseases