Clinical trial NCT03776006: Registry: TPLA for LUTS
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lower Urinary Tract Symptoms
Benign Prostate Hyperplasia
Benign Prostatic Hypertrophy With Outflow Obstruction
Keywords: Transperineal laser ablation
LUTS
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2018-12-14
Enrollment: 500
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


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)

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