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NCT Number: NCT06564415

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transperineal Laser Ablation of Prostate

Procedure

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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. 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)

  6. 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)

  7. 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)

  8. 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

  9. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Sessa

CONTACT

[email protected]

+39 3287305299

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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