THIS STUDY IS A RANDOMIZED CLINICAL TRIAL COMPARING TRANSURETHRAL PROSTATE RESECTION (TURP) AND ECHOLASER SORACTELITE-TRANSPERINEAL LASER ABLATION (TPLA) 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.
Lower urinary tract symptoms (IPSS >= 8);
Poor efficacy after at least six months of medical therapy or intolerance to medical treatment for BPH;
Prostate volume: 40ml-80ml;
Ability to give informed consent.
Previous surgery for benign prostatic hyperplasia;
Indwelling bladder catheter or intermittent bladder catheterization;
Diagnosis of bladder stones;
Recurrent urinary tract infections or intraprostatic abscesses;
Parallel
ECHOLASER-TPLA
Procedure/Surgerytransperineal laser ablation of prostatic adenoma, by transrectal ultrasound guide.
TURP
Procedure/SurgeryTransurethral resection of prostate, by uretrocistoscopy approach.
Symptomatology Improvement by International Prostate Symptoms Score (PSS-SCORE)
After 3,6 and 12 months of follow-up International Prostate Symptom Score (IPSS) questionnaire will be administered to all participants to evaluate changes in subjective symptoms and quality of life (Lower IPSS values indicate an improvement in the symptoms reported by the patient). The IPSS ranges from 0 to 35, with scores interpreted as follows: 0-7 indicates mild symptoms, 8-19 indicates moderate symptoms, and 20-35 indicates severe symptoms
Changes in the maximum urinary flow rate at Uroflowmetry (Qmax)
Uroflowmetry will be conducted to assess improvements in urinary maximum flow (Qmax: ml/sec). Differences among preoperative status versus 6, 12 months after treatment
Change in Ejaculatory function as assessed by the Male Sexual Health Questionnaire - Ejaculatory function domain (MSHQ-EJD)
To assess the impact of the procedures on anterograde ejaculatory function, we will use the Male Sexual Health Questionnaire - Ejaculation Disfunction (MSHQ-EJD). Higher scores reflect better ejaculatory function, with the questionnaire ranging from 0 to 15. Additionally, a final question, scored from 0 to 5, assesses the difficulty experienced by the patient during ejaculation. For this specific question, higher scores correspond to greater levels of difficulty reported (0: no difficulty, 5: extremely bothered).
Changes in Post Void Residual (PVR)
Uroflowmetry will be conducted to assess improvements post voided residual (PVR: ml). Milliliters will be used to report PVR
Changes in Sexual Funtion
To assess the impact of the procedures on penile erection, we will use the International Index of Erectile Function (IIEF5) questionnaire. The questionnaire hasn't got units of measurement; they are expressed in absolute numbers. Higher IIEF5 values indicate better erectile function. The IIEF-5 score ranges from 0 to 25. Scores of 22 to 25 indicate normal erectile function, while scores of 17 to 21 suggest mild erectile dysfunction. Scores between 12 and 16 indicate mild-to-moderate dysfunction, 8 to 11 moderate dysfunction, and scores below 7 indicate severe erectile dysfunction
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