NCT03776006

Registry: TPLA for LUTS

Not yet recruiting Last updated 18 January 2019

What this trial tests

trial testing Transperineal Laser Ablation in Lower Urinary Tract Symptoms in 500 participants. Not yet recruiting.

Timeline

1 February 2019

Primary endpoint
1 February 2029

1 February 2029

Quick facts

Lead sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	500
Start date	1 February 2019
Primary completion	1 February 2029
Estimated completion	1 February 2029

Drugs / interventions tested

• Transperineal Laser Ablation

Conditions studied

• Lower Urinary Tract Symptoms — all drugs for Lower Urinary Tract Symptoms →
• Benign Prostate Hyperplasia — all drugs for Benign Prostate Hyperplasia →
• Benign Prostatic Hypertrophy With Outflow Obstruction — all drugs for Benign Prostatic Hypertrophy With Outflow Obstruction →

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →

Who can join

Eligibility, male only, with Lower Urinary Tract Symptoms or Benign Prostate Hyperplasia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Transperineal Laser Ablation Treatment for Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction: Protocol for a Prospective In Vivo Pilot Study.
   van Kollenburg RAA, van Riel LAMJG, Bloemen PR, Oddens JR, et al · · 2020 · cited 20× · PMID 31961326 · DOI 10.2196/15687