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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
160
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.
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
Clinical symptoms changes at 6 months and 12 months follow-up evaluated with objective and subjective parameters
Improvement of obstructive symptomatology correlated to BPH. The evaluation will be based on urodynamic studies of Qmax, post void and residual volume
Time frame: 12 months
Treatment safety measured by complications incidence
Number of incidence of Complication according to modified Clavien classification system
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.