RANDOMIZED
Conditions
Brief summary
THIS STUDY IS A RANDOMIZED CLINICAL TRIAL COMPARING TRANSURETHRAL PROSTATE RESECTION (TURP) AND ECHOLASER SORACTELITE-TPLA (TRANSPERINEAL LASER ABLATION) IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC OBSTRUCTION. THE PRIMARY GOAL IS TO SHOW THE NON-INFERIORITY OF TPLA VERSUS TURP BY IPSS-SCORE.
Interventions
PROCEDUREECHOLASER-TPLA
transperineal laser ablation of prostatic adenoma, by transrectal ultrasound guide.
PROCEDURETURP
Transurethral resection of prostate, by uretrocistoscopy approach.
Sponsors
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* age, Lower urinary tract simptoms (IPSS \>= 8), uncompliance or no achived drugs treatment for IPB, prostate volume 40ml-80ml , ability to express informed consent.
Exclusion criteria
* previous surgical tretment for IPB, bladder catheter, bladder stones, urinary or seminal infections, hypo-/a-contractilitis of bladder, bladder tuomrs, urethral stricture, neurological bladder, refuse to sign informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IS TO SHOW THE NON-INFERIORITY OF TPLA VERSUS TURP BY IPSS-SCORE | one, three, six, twelve mounth after treatment |
Secondary
| Measure | Time frame |
|---|---|
| COMPARE Q-MAX UROFLOW | one, three, six, twelve mounth after treatment |
| COMPARE INPATIENT-TIMING | one, three, six, twelve mounth after treatment |
Countries
Italy
Contacts
Primary ContactMarcello MZ Zingarelli, medicine and surgery
Outcome results
None listed