TRP Versus Photo Selective Vaporization for Obstructive Benign Prostatic Hyperplasia Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Procedure: TURP
* Procedure: PVP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1 : TURP<br>Surgery: TransUrethral Resection of the Prostate | Procedure: TURP<br>* TransUrethral Resection of the Prostate<br>|
| Other: 2 : PVP<br>Surgery: Photo selective Vaporization of the Prostate | Procedure: PVP<br>* Photo selective Vaporization of the Prostate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Prostate, Laser 532 nm, Photo selective Vaporization of the Prostate (PVP), TransUrethral Resection of the Prostate (TURP), Men health