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European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms

ConditionsBenign Prostatic HyperplasiaProstatic Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorUniversity of Florence

About this trial

The goal of this observational study is to assess mid- and long-term effectiveness of Transperineal Laser Ablation of Prostate (TPLA) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic obstruction measured by need and/or time until surgical retreatment.

Data regarding patient-reported outcomes measures (PROMs), flowmetry parameters and safety about consecutive patients undergoing TPLA will be collected in a dedicated platform.

Secondary objectives of the study are:

* To assess functional and safety outcomes in patients treated with transperineal laser ablation for LUTS due to benign prostatic obstruction; * To identify possible differences in characteristics of patients treated with transperineal laser ablation among the centers and possible relations between treatment application and outcomes, in order to explore the optimal indications and possible limitations of TPLA for LUTS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years;

Prostate volume ≥ 30 mL;

Moderate-to-severe LUTS according to International Prostatic Symptoms Score (IPSS ≥8)

Consent to participate;

Disqualifiers

Absence of consent;

Subsequent withdrawal of consent;

Diagnosis or suspicion of prostate cancer at multiparametric magnetic resonance

Documented bladder impaired contractility

Trial population

Patients referred to the centers participating in the study

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Transperineal Laser Ablation of Prostate

    Procedure/Surgery

    Transperineal Laser Ablation of the Prostate is an ultra minimally-invasive procedure that consists in the insertion trough the perineum skin of laser fibers into the prostatic adenoma, under US guidance. Laser energy generates an area of coagulative necrosis that will bring to a reduction of the prostatic volume.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Rate of partecipants needing for other surgery

Mid- and long-term effectiveness of TPLA measured by need and/or time until surgical retreatment for BPO (e.g. Transurethral resection of prostate (TURP), endoscopic enucleation, simple prostatectomy)

Time frame
5 years

Secondary outcomes

1

Number of Participants with Treatment-Related Adverse Events according to Clavien-Dindo Scale

Number of Participants with Treatment-Related Adverse Events as Assessed by Clavien-Dindo scale (score from I to V - higher scores mean a worse outcome)

Time frame
6 months
2

Number of Participants with Treatment-Related Adverse Events according to Comprehensive Complication Index

Number of Participants with Treatment-Related Adverse Events as Assessed by Comprehensive Complication Index. The Comprehensive Complication Index (CCI) reflects the gravity of the overall complication burden on the patient on a scale from 0 (no complication) to 100 (death)

Time frame
6 months
3

Change from Baseline in the International Prostatic Symptoms Score (IPSS)

Patient-reported outcome measure about urinary symptoms evaluated by International Prostatic Symptoms Score (IPSS) - values from 0 to 35 (higher scores mean a worse outcome)

Time frame
5 years
4

Change from Baseline in the IPSS - Quality of Life score

Patient-reported outcome measure about impact of urinary symptoms on quality of life evaluated by IPSS - Quality of Life (QoL) questionnaire (values from 0 to 6 - higher scores mean a worse outcome)

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florence

Lead sponsor

Source ClinicalTrials.gov
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