Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia

Not Applicable

• Conditions: Lower Urinary Tract Symptoms; BPH
• Interventions: Device: Transperineal Focal Laser Ablation (TPLA)

• Registration Number: NCT04198103
• Lead Sponsor: University of Rome Tor Vergata

Brief 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.

Study Timeline

• Study Start: 2018-11-01
• Primary Completion: 2019-11-01
• Study First Submitted: 2019-11-08
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-12
• Last Update Submitted: 2019-12-12
• Study First Posted: 2019-12-13
• Last Update Posted: 2019-12-13
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SoracteLite	Transperineal Focal Laser Ablation (TPLA)	Transperineal Focal Laser Ablation (TPLA)

Primary Outcome Measures

Name	Time	Method
Clinical symptoms changes at 6 months and 12 months follow-up evaluated with objective and subjective parameters	12 months	Improvement of obstructive symptomatology correlated to BPH. The evaluation will be based on urodynamic studies of Qmax, post void and residual volume

Secondary Outcome Measures

Name	Time	Method
Treatment safety measured by complications incidence	30 days	Number of incidence of Complication according to modified Clavien classification system

Trial Locations

Locations (4)

Casa di Cura Santa Rita; 🇮🇹 Atripalda, AV, Italy

ASST Bergamo Est; 🇮🇹 Seriate, BG, Italy

Policlinico Tor Vergata (PTV) Foundation: UOC Department of Diagnostic Imaging and Interventional Radiology; 🇮🇹 Rome, RM, Italy

IGreco Ospedali Riuniti; 🇮🇹 Cosenza, Italy