Actively Recruiting
Randomized Clinical Trial Comparing Transurethral Prostate Resection (TURP) and Echolaser Soractelite-TPLA (Transperineal Laser Ablation) for Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction
Led by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Updated on 2025-12-17
80
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial is investigating treatments for lower urinary tract symptoms caused by benign prostatic obstruction in men aged 40 to 85. The study compares two procedures: transurethral prostate resection (TURP) and Echolaser Soractelite-Transperineal Laser Ablation (TPLA). The goal is to determine whether TPLA is not worse than TURP in improving symptoms as measured by the International Prostate Symptom Score (IPSS). Participants are randomly assigned to receive either the TPLA procedure, which uses transperineal laser ablation guided by transrectal ultrasound, or the TURP procedure, which involves transurethral resection of the prostate via uretrocystoscopy. Both treatments aim to relieve urinary symptoms by addressing prostate enlargement. During the study, participants will be monitored at one, three, six, and twelve months after treatment. Researchers will measure symptom scores using IPSS, compare urine flow rates (Q-Max uroflow), and track inpatient timing related to treatment. The study will assess and compare these outcomes to evaluate the safety and effectiveness of each procedure over time.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged between 40 and 85 years
- Lower urinary tract symptoms with IPSS score of 8 or higher
- Prostate volume between 40ml and 80ml
- Unresponsive or intolerant to drug treatment for benign prostatic obstruction
- Ability to give informed consent
You will not qualify if you...
- Previous surgical treatment for benign prostatic obstruction
- Presence of bladder catheter
- Bladder stones
- Urinary or seminal infections
- Bladder hypo- or a-contractility
- Bladder tumors
- Urethral stricture
- Neurological bladder
- Refusal to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with follow-up assessments over 12 months
Participants undergo either transperineal laser ablation (ECHOLASER-TPLA) or transurethral resection of the prostate (TURP) to treat lower urinary tract symptoms due to benign prostatic obstruction.
1 procedure visit and 4 follow-up visits at 1, 3, 6, and 12 months
Trial Site Locations
Total: 2 locations
1
UOC Urologia e Trapianti di Rene Policlinico di Bari
Bari, ITALY/Bari, Italy, 70124
Actively Recruiting
2
UOC Urologia e Trapianti di Rene Policlinico di Bari
Bari, ITALY/Bari, Italy, 70124
Active, Not Recruiting
Research Team
M
Marcello MZ Zingarelli, medicine and surgery
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here