Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia

University of Rome Tor Vergata

Status: Unknown

Conditions: Lower Urinary Tract Symptoms; BPH

Treatments: Device: Transperineal Focal Laser Ablation (TPLA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04198103

RS.99

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male
• ≥ 50 years of age
• International Prostate Symptoms (IPSS) ≥12
• Peak urinary flow rate (Qmax): <15 ml
• Prostate volume: ≥ 30 ml, measured by transrectal ultrasound
• Post-void residual (PVR): <400 ml
• Signed informed consent

Exclusion criteria

• MRI signs of malignancy confirmed by biopsy investigation
• urethral stenosis
• serious coagulation disorders
• inadequate compliance
• ischemic pathology in the previous six months
• active phase inflammatory pathology

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

SoracteLite

Experimental group

Description:

Transperineal Focal Laser Ablation (TPLA)

Treatment:

Device: Transperineal Focal Laser Ablation (TPLA)