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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- BPH
- Sponsor
- University of Rome Tor Vergata
- Enrollment
- 160
- Locations
- 4
- Primary Endpoint
- Clinical symptoms changes at 6 months and 12 months follow-up evaluated with objective and subjective parameters
- Last Updated
- 6 years ago
Overview
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.
Investigators
Guglielmo Manenti
Principle Investigator
University of Rome Tor Vergata
Eligibility Criteria
Inclusion Criteria
- •≥ 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
Outcomes
Primary Outcomes
Clinical symptoms changes at 6 months and 12 months follow-up evaluated with objective and subjective parameters
Time Frame: 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 Outcomes
- Treatment safety measured by complications incidence(30 days)