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Not yet recruiting NCT03776006

Registry: TPLA for LUTS

— Observational Lower Urinary Tract Symptoms Benign Prostate Hyperplasia Benign Prostatic Hypertrophy With Outflow Obstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transperineal Laser Ablation.
Who it may be relevant to
Registry conditions: Lower Urinary Tract Symptoms, Benign Prostate Hyperplasia, Benign Prostatic Hypertrophy With Outflow Obstruction. Basic parameters: No limits · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure Transperineal Laser Ablation
    Transperineal Laser Ablation of the Prostate

Primary outcome measures

  • Long-term treatment efficacy measured by the time until surgical retreatment. [Time frame: 5 years following TPLA treatment]
Secondary outcome measures (5)
  • Experienced functional efficacy measured by change in International Prostate Symptom Score [Time frame: 12 months following TPLA treatment]
  • Objectified functional efficacy measured by change of maximum flow by uroflowmetry. [Time frame: 12 months following TPLA treatment]
  • Long-term treatment efficacy measured by the time until restart of urological medication. [Time frame: 5 years following TPLA treatment]
  • Procedural safety measuered by the incidence of TPLA procedure related adverse events, reported by the CTCAE v5.0.. [Time frame: 1 day following TPLA treatment]
  • Treatment safety measured by adverse event incidence at 30 days, reported by the CTCAE v5.0 [Time frame: 30 days following TPLA treatment]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT03776006 · W18_316

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗