RANDOMIZED
Conditions
Brief summary
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.
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
* 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.
Exclusion criteria
* Previous surgery for benign prostatic hyperplasia; * Indwelling bladder catheter or intermittent bladder catheterization; * Diagnosis of bladder stones; * Recurrent urinary tract infections or intraprostatic abscesses; * Severe detrusor hypocontractility or acontractility; * Hydronefrosis due to urinary retention; * Urethral strictures or diagnosis of neurogenic bladder; * Diagnosis of bladder cancer; * Diagnosis or clinical suspicion of prostate cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatology Improvement by International Prostate Symptoms Score (PSS-SCORE) | one, three, six, twelve months after treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the maximum urinary flow rate at Uroflowmetry (Qmax) | Differences among preoperative status versus 6, 12 months after treatment | 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) | Differences among preoperative status versus 3, 6, 12 months after treatmente, three, six, twelve mounth after treatment | 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) | Differences among preoperative status versus 3, 6, 12 months after treatment | Uroflowmetry will be conducted to assess improvements post voided residual (PVR: ml). Milliliters will be used to report PVR |
| Changes in Sexual Funtion | Differences among preoperative status versus 3, 6, 12 months after treatment | 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 |
| Change in NIH Chronic Prostatitis Symptom Index (NIH-CPSI) score | Differences among preoperative status versus 3, 6, 12 months after treatment | Total NIH-CPSI score ranging from 0 to 43, assessing pain, urinary symptoms, and quality of life. Higher scores indicate worse symptoms. |
| Change in Pelvic Pain and Urgency/Frequency (PUF) score | Differences among preoperative status versus 3, 6, 12 months after treatment | Pelvic Pain and Urgency/Frequency (PUF) questionnaire score (0-35), higher scores indicate worse symptoms. |
| Prostate Specific Antigen (PSA) value | Differences among preoperative status versus 3, 6, 12 months after treatment | PSA will be reported by combining nanograms and milliliters (ng/ml). |
| Postoperative complications | up to 3 months | 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. |
| Length of hospital stay | From hospital admission to discharge at three days (up to three days) | Duration of hospitalization measured in days from admission to discharge. |
| Duration of urinary catheterization | From catheter insertion to catheter removal at seven days (up to seven days) | Time (in days) from placement of the urinary catheter to its removal. |
| Operative time | During the surgical procedure (day 0) | Duration of the procedure measured in minutes |
Countries
Italy
Contacts
CONTACTMarcello MZ Zingarelli, medicine and surgery
Outcome results
None listed