Transperineal Laser Ablation for Treatment of Benign Prostatic Obstruction
Raktažodžiai
Santrauka
apibūdinimas
This study is set up as a prospective, single centre, interventional pilot study.
Eligible patients are diagnosed with LUTS due to BPO at the outpatient clinic of the department of Urology at the Academic Medical Center (AMC) and have an indication for surgical treatment. The investigators aim to include 20 patients.
Eligible patients will be informed about this study by the urologist in the outpatient clinic. Information about the study will be provided both orally and in written form.
The TPLA procedure is performed with the Echolaser X4 system. The system uses a diode laser source that operates at the 1064nm wavelength. The maximum energy delivered is 10 watts per laser source. The system works with the concept of thermoablation, resulting in coagulative necrosis of tissue. Two to four fibers are introduced in the prostate under untrasound vision. Ablation will be performed with 3 watts power per fibre and a total of 1200 - 1800 J will be delivered per fibre in 400 - 600 s.
Follow-up will exist of four visits following surgery at 4 weeks, three, six and 12 months. The visits imply medical history, adverse event registration, physical examination (on indication) and uroflowmetry. Patient-reported outcome measures (PROMs) are used to measure functional outcomes. Used PROMs are the International Prostate Symptom Score (IPSS), International Index of Erectile Function 15 (IIEF-15), Visual Analogue Scale (VAS) and hematuria grading scale (HGS). In addition to this, imaging will exist of a contrast enhanced ultrasound (CEUS) at four weeks and 12 months.
Datos
| Paskutinį kartą patikrinta: | 12/31/2018 |
| Pirmasis pateikimas: | 08/21/2018 |
| Numatytas registravimas pateiktas: | 08/27/2018 |
| Pirmas paskelbtas: | 08/30/2018 |
| Paskutinis atnaujinimas pateiktas: | 01/17/2019 |
| Paskutinis atnaujinimas paskelbtas: | 01/21/2019 |
| Faktinė studijų pradžios data: | 10/17/2018 |
| Numatoma pirminio užbaigimo data: | 06/30/2019 |
| Numatoma studijų užbaigimo data: | 06/30/2020 |
Būklė ar liga
Intervencija / gydymas
Device: TPLA
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: TPLA TPLA procedure | Device: TPLA Minimal invasive coagulation of prostatic tissue by laser |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 40 Years Į 40 Years |
| Tinkamos studijoms lytys | Male |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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 ≤ 120 cc, measured by transrectal ultrasound - Urodynamic investigation proven bladder outlet obstruction - Signed informed consent Exclusion Criteria: - Previous invasive prostate intervention (TURP, laser, ablation, etc.) - History of prostate or bladder cancer - Indwelling Foley catheter or clean intermittent catheterization (CIC) - PSA of ≥ 3.0 ng/mL without negative biopsies - Inability or unwillingness to tolerate temporary discontinuation of anticoagulation or anti-platelet therapy - Other conditions / status - Active urinary tract infection / prostatitis - Macroscopic haematuria without a known contributing factor - Poor detrusor muscle function or other neurological disorder that would impact bladder function (eg, multiple sclerosis, Parkinson's disease, spinal cord injuries, (diabetic) polyneuropathy) - Concurrent malignancy except basal skin cancer - History of lower urinary tract surgery (eg, TURP, laser, urinary diversion, artificial urinary sphincter, penile prosthesis) - History of pelvic radiation therapy or radical pelvic surgery - History of bladder neck contracture and/or urethral strictures within the 5 years prior to the informed consent date - Bladder stones - Medical contraindication for undergoing TPLA surgery (eg, infection, coagulopathy, significant cardiac or other medical risk factors for surgery) - Diagnosed or suspected bleeding disorder |
Rezultatas
Pirminės rezultatų priemonės
1. Incidence of technical successful TPLA treatments [24 hours following TPLA treatment]
2. Incidence of TPLA treatment-emergent adverse events [30 days following TPLA treatment]
Antrinės rezultatų priemonės
1. Functional outcomes of TPLA [12 months following TPLA treatment]
2. Spontaneous voiding post TPLA [24 hours following TPLA treatment]
3. Erectile function [12 months following TPLA treatment]
4. Antegrade ejaculation [12 months following TPLA treatment]
