NCT04198103

Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia

Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia: A Feasibility Study - Results at 6 and 12 Months From a Retrospective Multi-centric Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: University of Rome Tor Vergata · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study investigated the effectiveness and safety of SoracteLite ™- Trans-Perineal Laser ablation (TPLA) in the treatment of patients with symptomatic Benign Prostatic Hyperplasia (BPH) at 6 and 12 months follow-up

Detailed description

The purpose of this study was to investigate the effectiveness and safety of SoracteLite ™ - Trans-Perineal Laser ablation (TPLA) in the treatment of patients with symptomatic benign prostatic hyperplasia (BPH) at 6 and 12 months follow-up. Methods: Patients with urinary symptoms secondary to BPH underwent TPLA under local anaesthesia in four centers. Under US guidance, up to four 21G applicators were inserted in the prostatic tissue. Each treatment was performed with diode laser operating at 1064 nm changing the illumination time according to prostate size.

Conditions

• BPH
• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DEVICE	Transperineal Focal Laser Ablation (TPLA)	The intervention will take place in an ambulatory setting using EchoLaser system. The treatment consists of the trasmission of laser energy into the tissue through the percutaneous insertion of optical fiber under local anesthesia. Within each needle, an optic fiber of 300 µm will be inserted. Each ablation lasts 6 minutes and each fiber ablates 1800J at a power of 3W. At the end of the first ablation there is a pull-back of about 1 cm from the original ablation location. According to the dimension of the middle lobe of the prostate, multiple pullbacks can be used for a total duration of about 30minutes. At the end of the treatment corticosteroid is given for anti-edema and anti-inflammatory effects and Antibiotic therapy and gastroprotective therapy is given. After an adequate amount of time for observation, the patient is dismissed.

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-11-01
• Completion: 2020-03-01
• First posted: 2019-12-13
• Last updated: 2019-12-13

Locations

4 sites across 1 country: Italy