Набор скоро начнётся NCT07430423

The FLOW Registry.

— Наблюдательное Benign Prostatic Hyperplasia (BPH)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Benign Prostatic Hyperplasia (BPH). Базовые параметры: от 18 лет · Мужчины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

The FLOW Registry: Functional and Longitudinal Outcomes With Waterjet Ablation

Обзор

The purpose of this study is to create a database and prospective registry for data collection on patients with benign prostatic hyperplasia undergoing Aquablation of the prostate. All patients undergoing Aquablation of the prostate will be enrolled in the registry. Historical data from 1/1/2024- 11/30/2025 will be added through chart review. Current and future patient data will be collected through chart review during the subject's clinical care. Only data available in the electronic medical record will be collected and no additional data will be collected for research purposes. No biospecimens will be collected, and there are no physical risks from study participation.

Первичные конечные точки

Efficacy of aquablation procedure in patients with benign prostatic hyperplasia as assessed by the change in mean International Prostate Symptom Score (IPSS) [Срок оценки: Baseline to follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total after prostate aquablation]
Safety of the aquablation procedure in patients with BPH. [Срок оценки: Baseline to 30 days post-aquablation]
Efficacy of aquablation procedure in patients with benign prostatic hyperplasia as assessed by the change in Q max/uroflowmetry. [Срок оценки: Baseline to follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total after prostate aquablation.]

Вторичные конечные точки (8)

Change from baseline in urinary function [Срок оценки: Baseline and 3, 6, 12, and 24 months post-procedure]
Association between preoperative characteristics and clinical outcomes [Срок оценки: Baseline through 24 months post-procedure]
Rate of procedural failure requiring reoperation for benign prostatic hyperplasia [Срок оценки: Baseline to 24 months post-procedure]
Incidence of urethral stricture or bladder neck contracture [Срок оценки: 12 and 24 months post-procedure]
Relationship between prostate volume reduction and prostate-specific antigen (PSA) reduction [Срок оценки: Baseline to 6 months post-procedure]
Change from baseline in sexual function as assessed by the change in Male Sexual Health Questionnaire - Ejaculation Short Form (MSHQ-EjD) [Срок оценки: Baseline and 3, 6, 12, and 24 months post-procedure]
Change from baseline in quality of life scores as assess by the The International Prostate Symptom Score (IPSS-QoL) [Срок оценки: Baseline and 3, 6, 12, and 24 months post-procedure]
Change from baseline in sexual function as assessed by the change in SEXUAL HEALTH INVENTORY FOR MEN (SHIM) [Срок оценки: Baseline and 3, 6, 12, and 24 months post-procedure]

Критерии участия

Критерии включения

Male sex
≥18 years of age
Diagnosis of benign prostatic hyperplasia
Scheduled to undergo or have already undergone Aquablation as part of routine clinical care or any ongoing clinical trials
Aquablation performed with ultrasound guided, robotic assisted waterjet. Newer methods and instrumentation continue to be developed to ablate tissue, and these energy sources can be entered into the registry as clinical use begins.