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

August 18, 2024 updated by: Francesco Sessa, University of Florence

European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Obstruction (BPO)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients referred to the centers participating in the study

Description

Inclusion Criteria:

  • Age ≥18 years;
  • Prostate volume ≥ 30 mL;
  • Moderate-to-severe LUTS according to International Prostatic Symptoms Score (IPSS ≥8)
  • Consent to participate;

Exclusion Criteria:

  • Absence of consent;
  • Subsequent withdrawal of consent;
  • Diagnosis or suspicion of prostate cancer at multiparametric magnetic resonance
  • Documented bladder impaired contractility
  • Urethral stenosis
  • Previous prostate surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of partecipants needing for other surgery
Time Frame: 5 years
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)
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment-Related Adverse Events according to Clavien-Dindo Scale
Time Frame: 6 months
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)
6 months
Number of Participants with Treatment-Related Adverse Events according to Comprehensive Complication Index
Time Frame: 6 months
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)
6 months
Change from Baseline in the International Prostatic Symptoms Score (IPSS)
Time Frame: 5 years
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)
5 years
Change from Baseline in the IPSS - Quality of Life score
Time Frame: 5 years
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)
5 years
Change from Baseline in the International Index of Erectile Function (IIEF-5)
Time Frame: 5 years
Patient-reported outcome measure about erectile function evaluated by International Index of Erectile Function (IIEF-5) - values from 0 to 25 (higher values mean a better outcome)
5 years
Change from Baseline in the Male Sexual Health Questionnaire bother (MSHQ bother)
Time Frame: 5 years
Patient-reported outcome measure about impact of ejaculatory disfunctions in quality of life evaluated by Male Sexual Health Questionnaire bother (MSHQ bother) - values from 0 to 5 (higher scores mean a worse outcome)
5 years
Change from Baseline in the Male Sexual Health Questionnaire 3-items (MSHQ 3-items)
Time Frame: 5 years
Patient-reported outcome measure about ejaculatory function evaluated by Male Sexual Health Questionnaire 3-items (MSHQ 3-items) - values from 0 to 15 (higher scores mean a better outcome)
5 years
Change from Baseline in maximum flow rate (ml/s)
Time Frame: 5 years
Change from Baseline in maximum flow rate (ml/s) evaluated at uroflowmetry
5 years
Change from Baseline in post void residual volume (ml)
Time Frame: 5 years
Change from Baseline in post void residual volume (ml) evaluated with sovrapubic ultrasound or bladderscan after spontaneous micturition
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florence

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2024

Primary Completion (Estimated)

January 1, 2034

Study Completion (Estimated)

January 1, 2034

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 18, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 18, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25691

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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