BPH, Lower Urinary Tract Symptoms
Conditions
Keywords
BPH, LUTS
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.
Interventions
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.
Sponsors
Ospedale Regina Apostolorum
European Institute of Oncology
University of Rome Tor Vergata
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Treatment safety measured by complications incidence | 30 days | Number of incidence of Complication according to modified Clavien classification system |
Countries
Italy
Outcome results
None listed