Benign Prostatic HyperplasiaREVAPRONCT01043588
TRP Versus Photo Selective Vaporization for Obstructive Benign Prostatic Hyperplasia Management
A study testing TURP and PVP in people with Benign Prostatic Hyperplasia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this study is to compare medical efficacy and cost effectiveness of two surgical options for obstructive BPH management : transurethral resection of the prostate with photo selective vaporization of the prostate using the high powered 532nm laser. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- TURP and PVP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2007to Feb 2011
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, 50 years of age or older.
- American Society of Anesthesiology (ASA) classification of physical status, class 1-3
- Signed an informed consent at the beginning of the study.
- Patients presenting with LUTS associated to benign prostatic enlargement for more than 3 months, needing a surgical management, with at least one of the following situations: disability score ≥3, I-PSS ≥12, or full urinary retention
- Qmax ≤12ml /s for no drained patients with voided volume> 125 ml.
- Estimated prostate weight between 25g and 80g
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- Patient free of catheter with PVR ≤ 300cc
- Patient without renal disorders.
- No prostate cancer suspicion at clinical examination, including DRE.
- PSA ≤ 10 ng/ml, with negative prostate biopsies of PSA is between 4 and 10 ng/mL if patient is 75 years or younger or has a life expectancy of more than 10 years.
- In case of anticoagulation or anti-aggregation therapy, necessary preoperative visit by anaesthesiologist to determine the supply therapy around surgery.
- In case of current BPH medical management, alpha blockers and herbal medicines should be stopped one week before surgery and 5-alpha-reductase-inhibitors should be stopped one month before surgery.
- Patient must be affiliated to the French social healthcare or equivalent
Who cannot join
- Uncontrolled cardiopulmonary disorder, previously or recently diagnosed by standard methods
- Assessed sphincter detrusor dyssynergia, or myasthenia, multiple sclerosis, or Parkinson disease.
- History of pelvic lesions with abdominal sphincter injury.
- Urinary tract infection without antibiotics.
- Patient with urinary catheter or suprapubic catheter because of an acute urinary retention linked to an alternative diagnosis or impaired bladder sensation.
- Subject with neurogenic bladder and/or sphincter abnormalities
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- Subject with confirmed or suspected malignancy of the prostate or the bladder.
- Previous prostatic surgery.
- History of bladder stone, major hematuria, urethral stricture, bladder neck stenosis.
- Patient having a prosthesis in the procedure area
- Patient with an active anorectal disease
- Treatment emergency
- Individual unable to respect timing and visits determined by the protocol.
- Constitutional hemostasis and coagulation abnormalities not linked to oral medications
- Any disease or patient condition which can be a contra indication to his enrolment in the study, according to the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transurethral Resection of the Prostate With Photo Selective Vaporization of the Prostate Using the High Powered 532nm Laser Obstructive Benign Prostatic Hyperplasia Management: Focus on Efficiency and Cost-effectiveness
The aim of this study is to compare medical efficacy and cost effectiveness of two surgical options for obstructive BPH management : transurethral resection of the prostate with photo selective vaporization of the prostate using the high powered 532nm laser.
Read the detailed description
The aim of this study is to compare medical efficacy and cost effectiveness of two surgical options for obstructive BPH management : transurethral resection of the prostate with photo selective vaporization of the prostate using the high powered 532nm laser. Patients were randomized in two groups after inclusion. Perioperative data were collected, and follow-up was conducted for one month.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- TURP, PVP
- Keywords
- Surgery, Prostate, Laser 532 nm, Photo selective Vaporization of the Prostate (PVP), TransUrethral Resection of the Prostate (TURP), Men health
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TURPProcedure or surgery
TransUrethral Resection of the Prostate
PVPProcedure or surgery
Photo selective Vaporization of the Prostate
| Study group | Role | What they receive |
|---|---|---|
| 1 : TURP | Other | Surgery: TransUrethral Resection of the Prostate Receives: Procedure: TURP |
| 2 : PVP | Other | Surgery: Photo selective Vaporization of the Prostate Receives: Procedure: PVP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital stay
Measured: end of hospitalization
Clinical symptoms at 1-yr follow-up evaluated with usual objective and subjective parameters
Measured: at one year
Secondary outcomes (6)
Rate of complication needing re-hospitalisation or reintervention
Measured: from the surgical procedure until one year follow-up
Risk of ignoring a localized prostate cancer needing a curative management.
Measured: at one year
Total and post-operative costs during follow-up.
Measured: from the surgical procedure until one year follow-up
Evaluation of side effects during follow-up.
Measured: from the surgical procedure until one year follow-up
Patient satisfaction
Measured: during follow up
Evaluation of quality of life
Measured: during follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startNov 2007
- Primary completionDec 2009
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, American Medical Systems
- Responsible party
- Sponsor
- Investigators
- Bertrand LUKACS, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043588
- Sponsor's protocol ID
- K060401
- Acronym
- REVAPRO
- Status last verified
- Dec 2012
- First submitted
- 21 Dec 2009
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bachmann A, Schurch L, Ruszat R, Wyler SF, Seifert HH, Muller A, Lehmann K, Sulser T. Photoselective vaporization (PVP) versus transurethral resection of the prostate (TURP): a prospective bi-centre study of perioperative morbidity and early functional outcome. Eur Urol. 2005 Dec;48(6):965-71; discussion 972. doi: 10.1016/j.eururo.2005.07.001. Epub 2005 Jul 18.
PubMed 16126327Lukacs B, Loeffler J, Bruyere F, Blanchet P, Gelet A, Coloby P, De la Taille A, Lemaire P, Baron JC, Cornu JN, Aout M, Rousseau H, Vicaut E; REVAPRO Study Group. Photoselective vaporization of the prostate with GreenLight 120-W laser compared with monopolar transurethral resection of the prostate: a multicenter randomized controlled trial. Eur Urol. 2012 Jun;61(6):1165-73. doi: 10.1016/j.eururo.2012.01.052. Epub 2012 Feb 8.
PubMed 22341632
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transurethral Resection of the Prostate With Photo Selective Vaporization of the Prostate Using the High Powered 532nm Laser Obstructive Benign Prostatic Hyperplasia Management: Focus on Efficiency and Cost-effectiveness
- ClinicalTrials.gov ID
- NCT01043588
- Acronym / sponsor ID
- REVAPRO / K060401
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Surgery, Prostate, Laser 532 nm, Photo selective Vaporization of the Prostate (PVP), TransUrethral Resection of the Prostate (TURP), Men health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France, American Medical Systems
- Study start
- Nov 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 7 Jan 2010 (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 aim of this study is to compare medical efficacy and cost effectiveness of two surgical options for obstructive BPH management : transurethral resection of the prostate with photo selective vaporization of the prostate using the high powered 532nm laser.
Detailed description
The aim of this study is to compare medical efficacy and cost effectiveness of two surgical options for obstructive BPH management : transurethral resection of the prostate with photo selective vaporization of the prostate using the high powered 532nm laser. Patients were randomized in two groups after inclusion. Perioperative data were collected, and follow-up was conducted for one month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 : TURP | Other | Procedure: TURPSurgery: TransUrethral Resection of the Prostate |
| 2 : PVP | Other | Procedure: PVPSurgery: Photo selective Vaporization of the Prostate |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male, 50 years of age or older.
- American Society of Anesthesiology (ASA) classification of physical status, class 1-3
- Signed an informed consent at the beginning of the study.
- Patients presenting with LUTS associated to benign prostatic enlargement for more than 3 months, needing a surgical management, with at least one of the following situations: disability score ≥3, I-PSS ≥12, or full urinary retention
- Qmax ≤12ml /s for no drained patients with voided volume> 125 ml.
Key exclusion criteria (15 listed)
- Uncontrolled cardiopulmonary disorder, previously or recently diagnosed by standard methods
- Assessed sphincter detrusor dyssynergia, or myasthenia, multiple sclerosis, or Parkinson disease.
- History of pelvic lesions with abdominal sphincter injury.
- Urinary tract infection without antibiotics.
- Patient with urinary catheter or suprapubic catheter because of an acute urinary retention linked to an alternative diagnosis or impaired bladder sensation.
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 |
|---|---|---|
| TURPTransUrethral Resection of the Prostate | Procedure or surgery | 1 : TURP |
| PVPPhoto selective Vaporization of the Prostate | Procedure or surgery | 2 : PVP |
Primary outcome
Hospital stay
Time frame: end of hospitalization
Clinical symptoms at 1-yr follow-up evaluated with usual objective and subjective parameters
Time frame: at one year
6 secondary outcomes
Rate of complication needing re-hospitalisation or reintervention
Time frame: from the surgical procedure until one year follow-up
Risk of ignoring a localized prostate cancer needing a curative management.
Time frame: at one year
Total and post-operative costs during follow-up.
Time frame: from the surgical procedure until one year follow-up
Evaluation of side effects during follow-up.
Time frame: from the surgical procedure until one year follow-up
Patient satisfaction
Time frame: during follow up
Evaluation of quality of life
Time frame: during follow up
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 1 May 2013.
- Background: PubMed 16126327Bachmann A, Schurch L, Ruszat R, Wyler SF, Seifert HH, Muller A, Lehmann K, Sulser T. Photoselective vaporization (PVP) versus transurethral resection of the prostate (TURP): a prospective bi-centre study of perioperative morbidity and early functional outcome. Eur Urol. 2005 Dec;48(6):965-71; discussion 972. doi: 10.1016/j.eururo.2005.07.001. Epub 2005 Jul 18.
- Derived from this study: PubMed 22341632Lukacs B, Loeffler J, Bruyere F, Blanchet P, Gelet A, Coloby P, De la Taille A, Lemaire P, Baron JC, Cornu JN, Aout M, Rousseau H, Vicaut E; REVAPRO Study Group. Photoselective vaporization of the prostate with GreenLight 120-W laser compared with monopolar transurethral resection of the prostate: a multicenter randomized controlled trial. Eur Urol. 2012 Jun;61(6):1165-73. doi: 10.1016/j.eururo.2012.01.052. Epub 2012 Feb 8.
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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.
Bertrand LUKACS, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TURP and PVP in people with Benign Prostatic Hyperplasia, run by Assistance Publique - Hôpitaux de Paris 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 13 inclusion and 15 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 1 May 2013. 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?
Hospital stay (time frame: end of hospitalization). The study lists 2 primary outcomes in all. 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 NCT01043588, which also lists 2 linked publications.
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 1 May 2013.