Registry: TPLA for LUTS

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT03776006
Study type	Observational [Patient Registry]
Source	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact	H Beerlage, Prof.
Phone	+31 20 5664776
Email	h.p.beerlage@amc.uva.nl
Status	Not yet recruiting
Phase
Start date	February 1, 2019
Completion date	February 1, 2029

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.