TRP Versus Photo Selective Vaporization for Obstructive Benign Prostatic Hyperplasia Management (REVAPRO)

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Procedure: TURP; Procedure: PVP

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 Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75020
    • Hôpital Tenon - Service d'Urologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Male, 50 years of age or older.
2. American Society of Anesthesiology (ASA) classification of physical status, class 1-3
3. Signed an informed consent at the beginning of the study.
4. 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
5. Qmax ≤12ml /s for no drained patients with voided volume> 125 ml.
6. Estimated prostate weight between 25g and 80g
7. Patient free of catheter with PVR ≤ 300cc
8. Patient without renal disorders.
9. No prostate cancer suspicion at clinical examination, including DRE.
10. 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.
11. In case of anticoagulation or anti-aggregation therapy, necessary preoperative visit by anaesthesiologist to determine the supply therapy around surgery.
12. 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.
13. Patient must be affiliated to the French social healthcare or equivalent

Exclusion Criteria:

1. Uncontrolled cardiopulmonary disorder, previously or recently diagnosed by standard methods
2. Assessed sphincter detrusor dyssynergia, or myasthenia, multiple sclerosis, or Parkinson disease.
3. History of pelvic lesions with abdominal sphincter injury.
4. Urinary tract infection without antibiotics.
5. Patient with urinary catheter or suprapubic catheter because of an acute urinary retention linked to an alternative diagnosis or impaired bladder sensation.
6. Subject with neurogenic bladder and/or sphincter abnormalities
7. Subject with confirmed or suspected malignancy of the prostate or the bladder.
8. Previous prostatic surgery.
9. History of bladder stone, major hematuria, urethral stricture, bladder neck stenosis.
10. Patient having a prosthesis in the procedure area
11. Patient with an active anorectal disease
12. Treatment emergency
13. Individual unable to respect timing and visits determined by the protocol.
14. Constitutional hemostasis and coagulation abnormalities not linked to oral medications
15. Any disease or patient condition which can be a contra indication to his enrolment in the study, according to the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1 : TURP; Surgery: TransUrethral Resection of the Prostate	Procedure: TURP; TransUrethral Resection of the Prostate
Other: 2 : PVP; Surgery: Photo selective Vaporization of the Prostate	Procedure: PVP; Photo selective Vaporization of the Prostate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospital stay	end of hospitalization
Clinical symptoms at 1-yr follow-up evaluated with usual objective and subjective parameters	at one year

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of complication needing re-hospitalisation or reintervention	from the surgical procedure until one year follow-up
Risk of ignoring a localized prostate cancer needing a curative management.	at one year
Total and post-operative costs during follow-up.	from the surgical procedure until one year follow-up
Evaluation of side effects during follow-up.	from the surgical procedure until one year follow-up
Patient satisfaction	during follow up
Evaluation of quality of life	during follow up

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Ministry of Health, France; American Medical Systems
• Investigators: Principal Investigator: Bertrand LUKACS, MD, Assistance Publique - Hopitaux de Paris

Publications and helpful links

General 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.
• Lukacs 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: December 21, 2009
• First Submitted That Met QC Criteria: January 6, 2010
• First Posted (Estimate): January 7, 2010

Study Record Updates

• Last Update Posted (Estimate): May 1, 2013
• Last Update Submitted That Met QC Criteria: April 30, 2013
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Surgery; Prostate; Men health; Laser 532 nm; Photo selective Vaporization of the Prostate (PVP); TransUrethral Resection of the Prostate (TURP)
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: K060401