Transperineal Laser Ablation for Treatment of Benign Prostatic Obstruction

NCT03653117 | Completed

• 1 other identifier: 2018_149
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: With age a large group of men experience lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO). Standard treatment is a transurethral resection of the prostate or laser vaporization. As these techniques enter the prostate via the urethra, are invasive and require general or spinal anaesthesia. Transperineal laser ablation (TPLA) is a minimal invasive procedure, that can be performed under local anaesthesia. Objective: The primary objective of this study is to prove feasibility and safety of TPLA for LUTS due to BPO in healthy men. Secondary objectives: The secondary objectives are to determine functional voiding, erectile outcomes and changes on imaging.

Conditions

Prostatic Hyperplasia, Benign

Keywords

Transperineal laser ablation; LUTS; BPO; Laser ablation

Outcome Measures

Primary Outcomes (2)

• Incidence of technical successful TPLA treatments

  Number of technical successful performed TPLA treatments without failures related to the machine or procedure.

  24 hours following TPLA treatment

• Incidence of TPLA treatment-emergent adverse events

  Number of adverse events using the CTCAE v5.0. Procedural safety is shown when there are no adverse events of grade 3 or higher.

  30 days following TPLA treatment

Secondary Outcomes (4)

• Functional outcomes of TPLA

  12 months following TPLA treatment

• Spontaneous voiding post TPLA

  24 hours following TPLA treatment

• Erectile function

  12 months following TPLA treatment

• Antegrade ejaculation

  12 months following TPLA treatment

Study Arms (1)

TPLA

EXPERIMENTAL

TPLA procedure

Device: Transperineal laser ablation

Interventions

Transperineal laser ablation DEVICE

Minimal invasive coagulation of prostatic tissue by laser

Also known as: Echolaser X4

TPLA

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Elesta S.R.L.: collaborator

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Related Publications (1)

• van Kollenburg RAA, van Riel LAMJG, Oddens JR, de Reijke TM, van Leeuwen TG, de Bruin DM. Contrast-enhanced Ultrasound Imaging Following Transperineal Laser Ablation for Lower Urinary Tract Symptoms. Urology. 2025 Apr;198:141-147. doi: 10.1016/j.urology.2024.11.043. Epub 2024 Nov 26.

  PMID: 39603354 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of the Urology department

Model Details: This study is a prospective, single centre, interventional pilot study.

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 31, 2018
• Study Start: October 18, 2018
• Primary Completion: May 23, 2022
• Study Completion: May 23, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

NL (1)