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

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, France
American Medical Systems
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01043588
First received: December 21, 2009
Last updated: April 30, 2013
Last verified: December 2012
  Purpose

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.


Condition Intervention
Benign Prostatic Hyperplasia
Procedure: TURP
Procedure: PVP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Hospital stay [ Time Frame: end of hospitalization ] [ Designated as safety issue: No ]
  • Clinical symptoms at 1-yr follow-up evaluated with usual objective and subjective parameters [ Time Frame: at one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of complication needing re-hospitalisation or reintervention [ Time Frame: from the surgical procedure until one year follow-up ] [ Designated as safety issue: Yes ]
  • Risk of ignoring a localized prostate cancer needing a curative management. [ Time Frame: at one year ] [ Designated as safety issue: Yes ]
  • Total and post-operative costs during follow-up. [ Time Frame: from the surgical procedure until one year follow-up ] [ Designated as safety issue: No ]
  • Evaluation of side effects during follow-up. [ Time Frame: from the surgical procedure until one year follow-up ] [ Designated as safety issue: Yes ]
  • Patient satisfaction [ Time Frame: during follow up ] [ Designated as safety issue: No ]
  • Evaluation of quality of life [ Time Frame: during follow up ] [ Designated as safety issue: No ]

Enrollment: 142
Study Start Date: November 2007
Study Completion Date: February 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 : TURP
Surgery: TransUrethral Resection of the Prostate
Procedure: TURP
TransUrethral Resection of the Prostate
2 : PVP
Surgery: Photo selective Vaporization of the Prostate
Procedure: PVP
Photo selective Vaporization of the Prostate

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043588

Locations
France
Hôpital TENON - Service d'Urologie
Paris, France, 75020
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
American Medical Systems
Investigators
Principal Investigator: Bertrand LUKACS, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01043588     History of Changes
Other Study ID Numbers: K060401
Study First Received: December 21, 2009
Last Updated: April 30, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Surgery
Prostate
Laser 532 nm
Photo selective Vaporization of the Prostate (PVP)
TransUrethral Resection of the Prostate (TURP)
Men health

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014