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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Transperineal Laser Ablation of Prostate
  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.

Первичные конечные точки

• Rate of partecipants needing for other surgery [Срок оценки: 5 years]

Вторичные конечные точки (9)

• Number of Participants with Treatment-Related Adverse Events according to Clavien-Dindo Scale [Срок оценки: 6 months]
• Number of Participants with Treatment-Related Adverse Events according to Comprehensive Complication Index [Срок оценки: 6 months]
• Change from Baseline in the International Prostatic Symptoms Score (IPSS) [Срок оценки: 5 years]
• Change from Baseline in the IPSS - Quality of Life score [Срок оценки: 5 years]
• Change from Baseline in the International Index of Erectile Function (IIEF-5) [Срок оценки: 5 years]
• Change from Baseline in the Male Sexual Health Questionnaire bother (MSHQ bother) [Срок оценки: 5 years]
• Change from Baseline in the Male Sexual Health Questionnaire 3-items (MSHQ 3-items) [Срок оценки: 5 years]
• Change from Baseline in maximum flow rate (ml/s) [Срок оценки: 5 years]
• Change from Baseline in post void residual volume (ml) [Срок оценки: 5 years]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• AOU Careggi — Florence

Публикации

• 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
• 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 PMID 38093618
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06564415 · 25691

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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