Transperineal Laser Ablation for treatment of LUTS due to benign prostatic obstructio

Completed

Conditions: 10046590
10036958
10038365
benign prostatic obstruction
enlarged prostate

Registration Number: NL-OMON55617

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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

- 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 (< 1 year) negative
prostate biopsies) based on:
o Abnormal digital rectal examination
o Urologists judgement of the PSA level, preferably supported by a
nomogram (e.g. Prostaatwijzer (version 3 with TRUS volume) outcome with an
indication for prostate biopsies.
- Inability or unwillingness to tolerate temporary discontinuation of
anticoagulation therapy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter for feasibility is the number of successful TPLA<br /><br>procedures. For safety the main study parameter is the number of grade 3<br /><br>adverse events based on the CTCAE v5.0 within the first 30 days.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secundairy study parameters are functional outcomes for voiding using<br /><br>uroflow and IPSS and erectile function using the IIEF. Furthermore tissue<br /><br>changes are evaluated with imaging.</p><br>