Registry: TPLA for LUTS

NCT ID: NCT03776006

Last Updated: 2019-01-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2029-02-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

TPLA

Transperineal Laser Ablation

Intervention Type: PROCEDURE

Transperineal Laser Ablation of the Prostate

Interventions

Transperineal Laser Ablation

Transperineal Laser Ablation of the Prostate

Intervention Type: PROCEDURE

Other Intervention Names

Echolaser X4

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)

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Dr. T.M. de Reijke

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

H Beerlage, Prof.

Role: CONTACT

h.p.beerlage@amc.uva.nl

+31 20 5664776

Other Identifiers

W18_316

Identifier Type: -

Identifier Source: org_study_id