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Registry: TPLA for LUTS

A

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Not yet enrolling

Conditions

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

Treatments

Procedure: Transperineal Laser Ablation

Study type

Observational

Funder types

Other

Identifiers

NCT03776006
W18_316

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

Male

Volunteers

No Healthy Volunteers

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)

Trial design

500 participants in 1 patient group

TPLA
Treatment:
Procedure: Transperineal Laser Ablation

Trial contacts and locations

0

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Central trial contact

H Beerlage, Prof.

Data sourced from clinicaltrials.gov

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