benign prostatic obstruction enlarged prostate
Conditions
Interventions
All subjects undergo a transperineal laser ablation of their prostate under
local anaesthesia using the Echolaser® system. Two to four laser fibres are
placed in the prostate and laser light induces
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male - 40 years of age - Peak urinary flow rate (Qmax): *5 mL/sec to *15 mL/sec, with a minimum voided volume of *125 mL, measured with uroflowmetry or urodynamic investigation - Post-void residual (PVR): * 250 mL - Prostate volume: * 30 and * 80 cc - Urodynamic investigation proven bladder outlet obstruction
Exclusion criteria
Exclusion criteria: - Previous invasive prostate intervention (TURP, laser, ablation, etc.) - History of prostate or bladder cancer - Indwelling Foley catheter or clean intermittent catheterization (CIC) - A clinical suspicion for prostate cancer (without recent (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter for feasibility is the number of successful TPLA procedures. For safety the main study parameter is the number of grade 3 adverse events based on the CTCAE v5.0 within the first 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secundairy study parameters are functional outcomes for voiding using uroflow and IPSS and erectile function using the IIEF. Furthermore tissue changes are evaluated with imaging. | — |
Countries
Netherlands
Outcome results
None listed