Registry: TPLA for LUTS

Registry of Transperineal Laser Ablation for Treatment of Lower Urinary Tract Symptoms With Use of the Echolaser® Device: A Multicentre, International Registry to Evaluate the Treatment of LUTS in Terms of Long-term Efficacy, Functional Outcomes and Safety

Rationale: The treatment of lower urinary tract symptoms (LUTS) due to benign prostatic enlargement in men with transperineal laser ablation (TPLA) may offer advantages in functional outcomes and safety over current standard therapies. As the technique is relatively new, indications and outcomes for this treatment are subject of investigation. However, the technique is already applied outside clinical studies. Clinical information from these treatments can be useful for future research. The aim of this study is to collect data on patients treated with transperineal laser ablation of the prostate outside clinical trials and to provide data on safety and functional outcomes in these patients in order to improve treatment.

Objective: To assess long-term efficacy of transperineal laser ablation for lower urinary tract symptoms, to assess functional outcomes, to assess safety, to determine baseline patient characteristics, to collect information on possible differences between centres applying treatment of transperineal laser ablation and to explore the optimal treatment indications and possible limitations.

Study design: This is an international prospective observational study in which data is recorded of patients who are treated with transperineal laser ablation for lower urinary tract symptoms.

Study population: Male patients treated with transperineal laser ablation for lower urinary tract symptoms due to benign prostatic enlargement.

Main study parameters/endpoints: The primary endpoint of this study is long-term efficacy of transperineal laser ablation for lower urinary tract symptoms measured by the time until surgical retreatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Urinary Tract Symptoms; Benign Prostate Hyperplasia; Benign Prostatic Hypertrophy With Outflow Obstruction
• Intervention / Treatment: Procedure: Transperineal Laser Ablation

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: H Beerlage, Prof.; Phone Number: +31 20 5664776; Email: h.p.beerlage@amc.uva.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

The study population comprises those patients presenting with lower urinary tract symptoms due to benign prostatic enlargement and are planned to undergo transperineal laser ablation in the participating centres.

Description

Inclusion Criteria:

• Male
• Presenting with lower urinary tract symptoms
• Indication for transperineal laser ablation
• Signed informed consent form

Exclusion Criteria:

• Age < 18 years
• Previous or active treatment for prostate cancer (active surveillance is not seen as active treatment)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TPLA	Procedure: Transperineal Laser Ablation; Transperineal Laser Ablation of the Prostate; Other Names: Echolaser X4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term treatment efficacy measured by the time until surgical retreatment.	The treatment effectiveness is measured by the time until the need for surgical retreatment. This is measured by the time between the TPLA treatment and retreatment indicated due to new micturion problems. The time is expressed in years.	5 years following TPLA treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experienced functional efficacy measured by change in International Prostate Symptom Score	The experienced functional efficacy is measured by change in the International Prostate Symptom Score (IPSS). The IPSS is a is a self-administered scale of 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) will be evaluated separately.	12 months following TPLA treatment
Objectified functional efficacy measured by change of maximum flow by uroflowmetry.	Change in maximum urinary flow rate after 12 months compared to baseline.	12 months following TPLA treatment
Long-term treatment efficacy measured by the time until restart of urological medication.	The treatment effectiveness is measured by the time until the need for medical treatment due to new miction symptoms. This is measured by the time between the TPLA treatment and start of medical treatment for LUTS. The time is expressed in years.	5 years following TPLA treatment
Procedural safety measuered by the incidence of TPLA procedure related adverse events, reported by the CTCAE v5.0..	Number of intraoperative adverse events using the CTCAE v5.0. Procedural safety is shown when no adverse events of grade 3 or higher.	1 day following TPLA treatment
Treatment safety measured by adverse event incidence at 30 days, reported by the CTCAE v5.0	Number of adverse events using the CTCAE v5.0. Treatment safety is shown when no adverse events of grade 3b or higher are reported at 30 days post-TPLA treatment.	30 days following TPLA treatment

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): February 1, 2029
• Study Completion (Anticipated): February 1, 2029

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 14, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 17, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: LUTS; Transperineal laser ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Pathological Conditions, Anatomical; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms; Hypertrophy
• Other Study ID Numbers: W18_316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No