Treatment for Benign Prostatic Obstruction: Transperineal Laser Ablation

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

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 Overview

• Status: Recruiting
• Conditions: RANDOMIZED
• Intervention / Treatment: Procedure: ECHOLASER-TPLA; Procedure: TURP

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcello MZ Zingarelli, medicine and surgery; Phone Number: +393405135446; Email: marcellozingarelli86@gmail.com

Study Locations

• Italy
  • ITALY/Bari
    • Bari, ITALY/Bari, Italy, 70124
      • Recruiting
      • UOC Urologia e Trapianti di Rene Policlinico di Bari
      • Contact: Pasquale PD Ditonno, medicine and surgery; Phone Number: +390805594390; Email: pasquale.ditonno@uniba.it
    • Bari, ITALY/Bari, Italy, 70124
      • Active, not recruiting
      • UOC Urologia e Trapianti di Rene Policlinico di Bari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: TPLA; Patients underwent TPLA tretment	Procedure: ECHOLASER-TPLA; transperineal laser ablation of prostatic adenoma, by transrectal ultrasound guide.; Other Names: TPLA
Other: TURP; Patients underwent TURP tretment	Procedure: TURP; Transurethral resection of prostate, by uretrocistoscopy approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one, three, six, twelve months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	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	Differences among preoperative status versus 3, 6, 12 months after treatment
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	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.	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.	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).	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.	up to 3 months
Length of hospital stay	Duration of hospitalization measured in days from admission to discharge.	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.	From catheter insertion to catheter removal at seven days (up to seven days)
Operative time	Duration of the procedure measured in minutes	During the surgical procedure (day 0)

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2024
• Primary Completion (Actual): December 25, 2025
• Study Completion (Estimated): December 25, 2026

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures; Urologic Surgical Procedures, Male; Prostatectomy; Transurethral Resection of Prostate
• Other Study ID Numbers: TPLA-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No