What is this study comparing for lower urinary tract symptoms due to benign prostatic obstruction?

This study is comparing two procedures called TPLA and TURP to see if TPLA works as well as TURP to improve urinary symptoms. Researchers want to find out if the laser-based TPLA is not worse than the standard TURP surgery. The study is led by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari.

Who may be eligible for this lower urinary tract symptoms clinical trial?

Men aged 40 to 85 with moderate to severe urinary symptoms and a prostate size between 40ml and 80ml may be eligible. They should not have had previous prostate surgeries or certain bladder conditions and must be able to give informed consent. Please review eligibility criteria for more details.

Is there any cost to participate in this lower urinary tract symptoms clinical trial?

Study-related care, including the procedures and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 40Years - 85Years

MALE

ID07289243

Study Comparing Two Procedures for Treating Urinary Symptoms from Benign Prostate Obstruction in Men Aged 40 to 85

Led by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Updated on 2025-12-17

Participants Needed

Research Sites

52 weeks

Total Duration

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

Age: 40Years - 85Years

MALE

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

Research Team

Marcello MZ Zingarelli, medicine and surgery

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