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Набор по приглашению NCT07159165

Registry of MIUS for Benign Prostatic Obstruction

— Наблюдательное Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

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
В протоколе указаны: Minimally invasive surgical treatment for benign prostatic obstruction.
Кому может быть актуально
Состояния в реестре: Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms. Базовые параметры: Без ограничений · 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Minimal Invasive Urology Society Benign Prostatic Obstruction (BPO) Study Group Data Collection Project

Обзор

This national, multicenter, prospective registry aims to collect standardized perioperative and follow-up data on patients undergoing minimally invasive surgical management for benign prostatic obstruction (BPO) in Turkey. Procedures include transurethral resection of the prostate (TURP), holmium/thulium laser enucleation (HoLEP/ThuLEP), Rezum®, and other contemporary techniques. By prospectively recording patient characteristics, surgical details, and postoperative outcomes in a unified electronic database, the project seeks to provide high-quality real-world evidence to support clinical decision-making, guideline updates, and future hypothesis-driven sub-studies.

Подробное описание

The ReMIUS-BPO registry is designed as a prospective, observational, multicenter cohort study under the coordination of the Minimal Invasive Urology Society. Participating centers will record preoperative, intraoperative, and postoperative data of patients undergoing minimally invasive surgery for BPO using a secure, standardized electronic case report form. Preoperative variables include demographics, comorbidities, medication history, prostate volume, and validated symptom scores (IPSS, OAB-V8). Intraoperative data include surgical technique, energy source, operative time, and complications. Postoperative follow-up will record early and late complications, catheterization time, changes in symptom scores, and re-intervention rates.

The registry aims to:

1. Create a comprehensive, analyzable national dataset for BPO surgery. 2. Compare surgical outcomes between different energy sources. 3. Evaluate the impact of the learning curve on operative time. 4. Determine long-term reoperation rates. The data will serve as a platform for future hypothesis-driven studies and potential embedded randomized controlled trials.

Вмешательства

  • Процедура Minimally invasive surgical treatment for benign prostatic obstruction
    Surgical management of BPO using contemporary minimally invasive procedures, including but not limited to: Transurethral resection of the prostate (TURP), Holmium laser enucleation of the prostate (HoLEP), Thulium laser enucleation of the prostate (ThuLEP), Rezum® water vapor thermal therapy. Procedures are performed according to standard clinical practice at each participating center, with perioperative and follow-up data prospectively recorded in the MIUS registry.

Первичные конечные точки

  • Proportion of eligible BPO surgery patients successfully enrolled with complete baseline, perioperative, and follow-up data in the MIUS registry [Срок оценки: Within 12 months after each patient's surgery date]
Вторичные конечные точки (4)
  • Comparison of perioperative complication rates between surgical techniques [Срок оценки: up to 4 weeks]
  • Change in International Prostate Symptom Score (IPSS) [Срок оценки: Baseline to 12 months post-surgery]
  • Change in maximum urinary flow rate (Qmax) [Срок оценки: Baseline to 12 months post-surgery]
  • Reoperation-free survival [Срок оценки: Up to 5 years post-surgery]

Критерии участия

Критерии включения

  • Male patients ≥ 18 years old
  • Diagnosis of BPO with clinical indication for minimally invasive surgery
  • Signed informed consent
  • Availability of complete baseline and follow-up data

Критерии исключения

  • No informed consent
  • Missing essential preoperative or follow-up data

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 Mayıs University — Samsun

Идентификаторы

NCT: NCT07159165 · MIUS.2025.001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗