Benign Prostatic Hyperplasia
Conditions
Keywords
Surgery, Prostate, Laser 532 nm, Photo selective Vaporization of the Prostate (PVP), TransUrethral Resection of the Prostate (TURP), Men health
Brief 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.
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.
Interventions
Sponsors
Ministry of Health, France
American Medical Systems
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Rate of complication needing re-hospitalisation or reintervention | from the surgical procedure until one year follow-up |
| Evaluation of quality of life | during follow up |
| Patient satisfaction | during follow up |
| Risk of ignoring a localized prostate cancer needing a curative management. | at one year |
Countries
France
Outcome results
None listed