Registry: TPLA for LUTS

NCT03776006 | Not Yet Recruiting DMC

• 1 other identifier: W18_316
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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

Keywords

Transperineal laser ablation; LUTS

Outcome Measures

Primary Outcomes (1)

• Long-term treatment efficacy measured by the time until surgical retreatment.

  The treatment effectiveness is measured by the time until the need for surgical retreatment. This is measured by the time between the TPLA treatment and retreatment indicated due to new micturion problems. The time is expressed in years.

  5 years following TPLA treatment

Secondary Outcomes (5)

• Experienced functional efficacy measured by change in International Prostate Symptom Score

  12 months following TPLA treatment

• Objectified functional efficacy measured by change of maximum flow by uroflowmetry.

  12 months following TPLA treatment

• Long-term treatment efficacy measured by the time until restart of urological medication.

  5 years following TPLA treatment

• Procedural safety measuered by the incidence of TPLA procedure related adverse events, reported by the CTCAE v5.0..

  1 day following TPLA treatment

• Treatment safety measured by adverse event incidence at 30 days, reported by the CTCAE v5.0

  30 days following TPLA treatment

Study Arms (1)

TPLA

Procedure: Transperineal Laser Ablation

Interventions

Transperineal Laser Ablation PROCEDURE

Transperineal Laser Ablation of the Prostate

Also known as: Echolaser X4

TPLA

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male
• Presenting with lower urinary tract symptoms
• Indication for transperineal laser ablation
• Signed informed consent form

You may not qualify if:

• Age \< 18 years
• Previous or active treatment for prostate cancer (active surveillance is not seen as active treatment)

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

H Beerlage, Prof.

CONTACT

+31 20 5664776; h.p.beerlage@amc.uva.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 14, 2018
• Study Start: February 1, 2019
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 18, 2019

Record last verified: 2019-01