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

NCT06564415 | Recruiting

• 1 other identifier: 25691
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia; Prostatic Diseases

Keywords

TPLA; Transperineal Laser Ablation; LUTS; BPH; Benign Prostatic Obstruction

Outcome Measures

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)

  5 years

Secondary Outcomes (9)

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

  6 months

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

  6 months

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

  5 years

• Change from Baseline in the IPSS - Quality of Life score

  5 years

• Change from Baseline in the International Index of Erectile Function (IIEF-5)

  5 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: only biological males can be included
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred to the centers participating in the study

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

AOU Careggi

Florence, 50134, Italy

RECRUITING

Related Publications (12)

• Sessa F, Polverino P, Siena G, Bisegna C, Lo Re M, Spatafora P, Pecoraro A, Rivetti A, Moscardi L, Saladino M, Cocci A, Gacci M, Li Marzi V, Carini M, Minervini A, Campi R, Serni S. Transperineal Laser Ablation of the Prostate (TPLA) for Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction. J Clin Med. 2023 Jan 19;12(3):793. doi: 10.3390/jcm12030793.

  PMID: 36769454 BACKGROUND

• Polverino P, Lo Re M, Saladino M, Pecoraro A, Moscardi L, Rivetti A, Resta GR, Pezzoli M, Romano A, Somani BK, Siena G, Cocci A, Gacci M, Minervini A, Serni S, Campi R, Sessa F. Could transperineal interstitial laser ablation of the prostate be the right option for highly-comorbid patients with lower urinary tract symptoms due to benign prostatic obstruction? A preliminary single-center experience focusing on functional and safety outcomes. Minerva Urol Nephrol. 2024 Oct;76(5):646-649. doi: 10.23736/S2724-6051.23.05479-4. Epub 2023 Dec 13.

  PMID: 38093618 BACKGROUND

• Lo Re M, Polverino P, Rivetti A, Pecoraro A, Saladino M, Pezzoli M, Siena G, De Nunzio C, Li Marzi V, Gacci M, Serni S, Campi R, Sessa F. Transperineal laser ablation (TPLA) of the prostate for benign prostatic obstruction: the first 100 patients cohort of a prospective, single-center study. World J Urol. 2024 Jul 10;42(1):402. doi: 10.1007/s00345-024-05077-z.

  PMID: 38985193 BACKGROUND

• Canat HL, Gurbuz C, Bozkurt M. Transurethral resection of the prostate (TURP) versus transperineal laser ablation (TPLA) due to benign prostatic hyperplasia (BPH): prospective and comparative study. Int Urol Nephrol. 2023 Nov;55(11):2747-2752. doi: 10.1007/s11255-023-03717-8. Epub 2023 Jul 27.

  PMID: 37498422 BACKGROUND

• Minafra P, DE Rienzo G, Gerbasi S, Cindolo L, Battaglia M, Ditonno P. Three years outcomes of transperineal laser ablation of the prostate. Minerva Urol Nephrol. 2023 Aug;75(4):471-478. doi: 10.23736/S2724-6051.23.05270-9. Epub 2023 Jun 14.

  PMID: 37314812 BACKGROUND

• Bertolo R, Iacovelli V, Cipriani C, Carilli M, Vittori M, Antonucci M, Maiorino F, Signoretti M, Petta F, Travaglia S, Panei M, Bove P. Ejaculatory function following transperineal laser ablation vs TURP for benign prostatic obstruction: a randomized trial. BJU Int. 2023 Jul;132(1):100-108. doi: 10.1111/bju.16008. Epub 2023 Mar 30.

  PMID: 36917033 BACKGROUND

• Patelli G, Ranieri A, Paganelli A, Mauri G, Pacella CM. Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia: A Feasibility Study. Cardiovasc Intervent Radiol. 2017 Sep;40(9):1440-1446. doi: 10.1007/s00270-017-1662-9. Epub 2017 May 4.

  PMID: 28474112 BACKGROUND

• Pacella CM, Patelli G, Iapicca G, Manenti G, Perretta T, Ryan CP, Esposito R, Mauri G. Transperineal laser ablation for percutaneous treatment of benign prostatic hyperplasia: a feasibility study. Results at 6 and 12 months from a retrospective multi-centric study. Prostate Cancer Prostatic Dis. 2020 Jun;23(2):356-363. doi: 10.1038/s41391-019-0196-4. Epub 2019 Dec 11.

  PMID: 31827239 BACKGROUND

• Manenti G, Perretta T, Calcagni A, Ferrari D, Ryan CP, Fraioli F, Meucci R, Malizia A, Iacovelli V, Agro EF, Floris R. 3-T MRI and clinical validation of ultrasound-guided transperineal laser ablation of benign prostatic hyperplasia. Eur Radiol Exp. 2021 Sep 17;5(1):41. doi: 10.1186/s41747-021-00239-9.

  PMID: 34532768 BACKGROUND

• Frego N, Saita A, Casale P, Diana P, Contieri R, Avolio PP, Lazzeri M, Hurle R, Buffi NM, Guazzoni GF, Lughezzani G. Feasibility, safety, and efficacy of ultrasound-guided transperineal laser ablation for the treatment of benign prostatic hyperplasia: a single institutional experience. World J Urol. 2021 Oct;39(10):3867-3873. doi: 10.1007/s00345-021-03685-7. Epub 2021 Apr 3.

  PMID: 33811512 BACKGROUND

• de Rienzo G, Lorusso A, Minafra P, Zingarelli M, Papapicco G, Lucarelli G, Battaglia M, Ditonno P. Transperineal interstitial laser ablation of the prostate, a novel option for minimally invasive treatment of benign prostatic obstruction. Eur Urol. 2021 Jul;80(1):95-103. doi: 10.1016/j.eururo.2020.08.018. Epub 2020 Aug 28.

  PMID: 32868137 BACKGROUND

• Cai HJ, Fang JH, Kong FL, Xu CK, Chen CH, Wang W, Huang B. Ultrasound-guided transperineal laser ablation for percutaneous treatment of benign prostatic hyperplasia: a new minimally invasive interventional therapy. Acta Radiol. 2022 Apr;63(4):553-558. doi: 10.1177/02841851211003289. Epub 2021 Mar 28.

  PMID: 33779301 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia; Prostatic Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Francesco Sessa

CONTACT

+39 3287305299; francesco_sessa@hotmail.it

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: August 14, 2024
• First Posted: August 21, 2024
• Study Start: January 11, 2024
• Primary Completion (Estimated): January 1, 2034
• Study Completion (Estimated): January 1, 2034
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

IT (1)