Enucleation Ratio as a Novel Predictor of Symptomatic Improvement After HoLEP

Официальное название

Predictive Value of Enucleation Ratio for Symptomatic Improvement After HoLEP: A Multicenter Prospective Cohort Study

Обзор

The goal of this observational study is to determine whether the rate of prostate tissue removed during surgery relative to the preoperative total prostate volume (referred to as the "enucleation ratio") predicts symptomatic improvement 3 months after HoLEP. The main question it aims to answer is: \- What is the minimum enucleation ratio required to achieve clinically important symptomatic improvement? (Symptomatic improvement is referred to as a threshold of having an International Prostate Symptom Score (IPSS) lower than 8 points, which is determined by the American Urological Association (AUA) and European Association of Urology(EAU)).

Подробное описание

HoLEP has become a widespread and well-practiced surgical method for benign prostate obstruction (BPO). The method is known to have a steep learning curve, and mastery requires extensive practice. Treatment efficiency depends on removing the obstruction while protecting the delicate external urethral sphincter.

However, it's still unclear which pre-operative and intra-operative factors affect surgical outcome. Some authors have already contributed to this subject; in fact, changes in peak urinary flow rate, IPSS-QoL, and the absence of stress urinary incontinence and high-grade complications are among the agreed-upon criteria for successful surgery. As the main purpose of HoLEP, or any other benign prostate surgeries, is to remove obstruction, the more adenoma tissue to be removed, the less obstruction there will be. Yet not anatomic, but there's a surgical capsule around the prostate, which can stretch, causing residual tissue to obstruct the urethral passage. Leaving residual adenoma tissue is not uncommon and may affect the efficacy of HoLEP, particularly given the steep learning curve of the procedure. Therefore, it may be reasonable for one to consider that the higher the ratio of adenoma tissue removed, the better the outcomes could be.

Enucleation ratio is a novel parameter that has not been investigated previously in this context and is calculated by dividing the weight (grams) of morcellated adenoma tissue by the preoperatively measured prostate volume (mL). The density of the prostate is widely accepted as 1 gram per milliliter, so the enucleation ratio has no units.

Identifying a minimum enucleation ratio associated with clinically meaningful symptomatic improvement could provide surgeons with a measurable intraoperative target, potentially improving procedural standardization and patient counseling - particularly during the learning curve of HoLEP.

Вмешательства

• Процедура Holmium laser enucleation of prostate (HoLEP)
  HoLEP is a widespread and minimally invasive surgical method to treat LUTS caused by BPO. En-bloc or tri-lobar technique will be performed according to the surgeon's preference during the procedure.

Первичные конечные точки

• Achievement of mild symptom category (IPSS < 8) at 3 months after HoLEP [Срок оценки: 3 months after HoLEP]

Вторичные конечные точки (4)

• QoL score reduction of at least 1 point from the baseline at 3 months after HoLEP [Срок оценки: 3 months after HoLEP]
• Qmax > 15 mL/s achievement rate at 3 months after HoLEP [Срок оценки: 3 months after HoLEP]
• Ratio of high grade complications (Clavien-Dindo grade III or higher) within 1 month after HoLEP [Срок оценки: Within 1 month following HoLEP]
• Ratio of stress urinary incontinence at 3 months after HoLEP [Срок оценки: 3 months after HoLEP]

Критерии участия

Критерии включения

• Men aged 18 years pr older who are planned to undergo HoLEP.
• Participants who are willing to give informed consent.
• Participants who have moderate to severe LUTS (referring to IPSS score 8 points or more).
• No history of previous prostate or urethral surgery.

Критерии исключения

• Unwillingness to provide informed consent.
• Unwillingness to provide contact information or unreachability during follow-up periods.
• Incidental diagnosis of a urogenital malignancy requiring primary treatment after enrollment (e.g., bladder tumor, renal cell carcinoma, testicular tumor).

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Ondokuz Mayis University, Faculty of Medicine, Department of Urology — Samsun

Публикации

• Alkan I, Ozveri H, Akin Y, Ipekci T, Alican Y. Holmium laser enucleation of the prostate: surgical, functional, and quality-of-life outcomes upon extended follow-up. Int Braz J Urol. 2016 Mar-Apr;42(2):293-301. doi: 10.1590/S1677-5538.IBJU.2014.0561. PMID 27256184
• Grosso AA, Di Maida F, Nardoni S, Salvi M, Giudici S, Lambertini L, Cadenar A, Tellini R, Cocci A, Mari A, Minervini A, Tuccio A. Patterns and Predictors of Optimal Surgical and Functional Outcomes after Holmium Laser Enucleation of the Prostate (HoLEP): Introducing the Concept of "Trifecta". World J Mens Health. 2023 Jul;41(3):603-611. doi: 10.5534/wjmh.220042. Epub 2023 Jan 1. PMID 36593708
• Jeong CW, Oh JK, Cho MC, Bae JB, Oh SJ. Enucleation ratio efficacy might be a better predictor to assess learning curve of holmium laser enucleation of the prostate. Int Braz J Urol. 2012 May-Jun;38(3):362-71; discussions 372. doi: 10.1590/s1677-55382012000300009. PMID 22765867

Идентификаторы

NCT: NCT07591688 · MIUS.2026.003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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