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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
80
transperineal laser ablation of prostatic adenoma, by transrectal ultrasound guide.
Transurethral resection of prostate, by uretrocistoscopy approach.
UOC Urologia e Trapianti di Rene Policlinico di Bari
Bari, ITALY/Bari, Italy
RECRUITINGUOC Urologia e Trapianti di Rene Policlinico di Bari
Bari, ITALY/Bari, Italy
ACTIVE_NOT_RECRUITINGSymptomatology 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
Time frame: one, three, six, twelve months after treatment
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
Time frame: 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).
Time frame: Differences among preoperative status versus 3, 6, 12 months after treatmente, three, six, twelve mounth after treatment
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
Time frame: Differences among preoperative status versus 3, 6, 12 months after treatment
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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
Time frame: Differences among preoperative status versus 3, 6, 12 months after treatment
Change in NIH Chronic Prostatitis Symptom Index (NIH-CPSI) score
Total NIH-CPSI score ranging from 0 to 43, assessing pain, urinary symptoms, and quality of life. Higher scores indicate worse symptoms.
Time frame: Differences among preoperative status versus 3, 6, 12 months after treatment
Change in Pelvic Pain and Urgency/Frequency (PUF) score
Pelvic Pain and Urgency/Frequency (PUF) questionnaire score (0-35), higher scores indicate worse symptoms.
Time frame: Differences among preoperative status versus 3, 6, 12 months after treatment
Prostate Specific Antigen (PSA) value
PSA will be reported by combining nanograms and milliliters (ng/ml).
Time frame: Differences among preoperative status versus 3, 6, 12 months after treatment
Postoperative complications
The Clavien-Dindo classification categorizes complications related to a surgical procedure on a scale from 1 to 5. The severity of the complication increases with higher Clavien-Dindo scores.
Time frame: up to 3 months
Length of hospital stay
Duration of hospitalization measured in days from admission to discharge.
Time frame: From hospital admission to discharge at three days (up to three days)
Duration of urinary catheterization
Time (in days) from placement of the urinary catheter to its removal.
Time frame: From catheter insertion to catheter removal at seven days (up to seven days)
Operative time
Duration of the procedure measured in minutes
Time frame: During the surgical procedure (day 0)