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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


N/A
50 Years
N/A
Not Enrolling
Male
Benign Prostatic Hyperplasia

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Trial Information

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. Patients were
randomized in two groups after inclusion. Perioperative data were collected, and follow-up
was conducted for one month.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Hospital stay

Outcome Time Frame:

end of hospitalization

Safety Issue:

No

Principal Investigator

Bertrand LUKACS, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris

Authority:

France: Ministry of Health

Study ID:

K060401

NCT ID:

NCT01043588

Start Date:

November 2007

Completion Date:

February 2011

Related Keywords:

  • Benign Prostatic Hyperplasia
  • Surgery
  • Prostate
  • Laser 532 nm
  • Photo selective Vaporization of the Prostate (PVP)
  • TransUrethral Resection of the Prostate (TURP)
  • Men health
  • Prostatic Hyperplasia
  • Hyperplasia

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