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Completed

NCT Number: NCT01732991

Assessing the Impact of the 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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Chru Tours

Tours, 37044, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prostatic photo-vaporization (PVP)

Device

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

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

Acronym: PROPIL

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 26, 2012
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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