Registry: TPLA for LUTS

Lower Urinary Tract Symptoms Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03776006
• Other study ID #: W18_316
• Status: Not yet recruiting
• Start date: February 1, 2019
• Est. completion date: February 1, 2029

Study information

• Verified date: January 2019
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: H Beerlage, Prof.
• Phone: +31 20 5664776
• Email: h.p.beerlage[@]amc.uva.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: February 1, 2029
• Est. primary completion date: February 1, 2029
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Transperineal Laser Ablation
Transperineal Laser Ablation of the Prostate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Experienced functional efficacy measured by change in International Prostate Symptom Score	The experienced functional efficacy is measured by change in the International Prostate Symptom Score (IPSS). The IPSS is a is a self-administered scale of 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) will be evaluated separately.	12 months following TPLA treatment
Secondary	Objectified functional efficacy measured by change of maximum flow by uroflowmetry.	Change in maximum urinary flow rate after 12 months compared to baseline.	12 months following TPLA treatment
Secondary	Long-term treatment efficacy measured by the time until restart of urological medication.	The treatment effectiveness is measured by the time until the need for medical treatment due to new miction symptoms. This is measured by the time between the TPLA treatment and start of medical treatment for LUTS. The time is expressed in years.	5 years following TPLA treatment
Secondary	Procedural safety measuered by the incidence of TPLA procedure related adverse events, reported by the CTCAE v5.0..	Number of intraoperative adverse events using the CTCAE v5.0. Procedural safety is shown when no adverse events of grade 3 or higher.	1 day following TPLA treatment
Secondary	Treatment safety measured by adverse event incidence at 30 days, reported by the CTCAE v5.0	Number of adverse events using the CTCAE v5.0. Treatment safety is shown when no adverse events of grade 3b or higher are reported at 30 days post-TPLA treatment.	30 days following TPLA treatment