Prostatic Hypertrophy, BenignPROPILNCT01732991
Assessing the Impact of the PVP With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound
A study testing prostatic photo-vaporization (PVP) in people with Prostatic Hypertrophy, Benign, run by University Hospital, Tours at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Hypertrophy, Benign
- What is being tested?
- prostatic photo-vaporization (PVP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Prostatic Hypertrophy, Benign
- Being tested
- prostatic photo-vaporization (PVP)
- Keywords
- Prostatic Hypertrophy, Benign, Greenlight laser, Prostatic photovaporization, Prostatic MRI, Prostatic contrast-enhanced ultrasound, Urinary irritative signs, Postoperative necrotic area
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| prostatic photo-vaporization | Experimental | prostatic photo-vaporization (PVP) surgery with laser Greenlight Receives: Device: prostatic photo-vaporization (PVP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: J0 (immediately after surgery) M1, M6 and M12
Secondary outcomes (2)
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)
Measured: J0, M1, M6 and M12
Evolution of prostatic volume over 12 months
Evolution of prostatic volume over 12 months (prostatic monitoring MRI and contrast-enhanced ultrasound)
Measured: J0, M1, M6 and M12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic Hypertrophy, BenignStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck BRUYERE, MD, Principal investigator, CHRU TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732991
- Sponsor's protocol ID
- PHAO 2012 - FB / PROPIL
- Acronym
- PROPIL
- Status last verified
- Aug 2015
- First submitted
- 19 Nov 2012
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23837622
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of the Prostatic Photo-vaporization (PVP) With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound
- ClinicalTrials.gov ID
- NCT01732991
- Acronym / sponsor ID
- PROPIL / PHAO 2012 - FB / PROPIL
- Conditions
- Prostatic Hypertrophy, Benign
- Keywords
- Prostatic Hypertrophy, Benign, Greenlight laser, Prostatic photovaporization, Prostatic MRI, Prostatic contrast-enhanced ultrasound, Urinary irritative signs, Postoperative necrotic area
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prostatic photo-vaporization | Experimental | Device: prostatic photo-vaporization (PVP)prostatic photo-vaporization (PVP) surgery with laser Greenlight |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | prostatic photo-vaporization |
Primary outcome
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.
2 secondary outcomes
Evolution of urinary irritative signs over 12 months
Time frame: J0, M1, M6 and M12
Evolution of prostatic volume over 12 months
Time frame: J0, M1, M6 and M12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Results publication: PubMed 23837622Bruyere 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.
Related trials for Prostatic Hypertrophy, Benign
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franck BRUYERE, MD principal investigator
CHRU TOURS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prostatic photo-vaporization (PVP) in people with Prostatic Hypertrophy, Benign, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of thickness of the average necrotic area (time frame: J0 (immediately after surgery) M1, M6 and M12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01732991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.