Registry: TPLA for LUTS

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
AgeNot listed
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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.

Eligibility criteria

Qualifiers

Male

Presenting with lower urinary tract symptoms

Indication for transperineal laser ablation

Signed informed consent form

Disqualifiers

Age < 18 years

Previous or active treatment for prostate cancer (active surveillance is not seen as active treatment)

Trial design

Treatments tested in this trial

  • Transperineal Laser Ablation

Treatment groups

500 Participants
are divided into 1 treatment group

Locations

This trial has no locations