TURP Outcome Prediction Calculator Study
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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
- Список центров уточняется — проверьте первичный протокол.
- 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
Identification of Predictive Parameters for Developing a TURP Outcome Calculator for Preoperative Patient Assessment
Обзор
The goal of this observational study is to identify which preoperative clinical, ultrasound, and uroflowmetry parameters can help predict the success of transurethral resection of the prostate (TURP) in adult male patients with symptomatic benign prostatic hyperplasia (BPH). The main questions it aims to answer are: Which preoperative parameters (IPSS, prostate volume, post-void residual urine, Qmax, comorbidities) are associated with successful postoperative outcomes? Can these parameters be used to develop a non-invasive calculator to estimate the likelihood of TURP success? Participants will undergo routine clinical evaluation that is part of standard care, including: * completion of the IPSS questionnaire * digital rectal examination * ultrasound measurement of prostate volume and residual urine * uroflowmetry (Qmax and voided volume) * standard laboratory testing Eligible participants will then undergo TURP as clinically indicated and return for postoperative assessments of symptom improvement and urinary flow parameters.
Подробное описание
Benign prostatic hyperplasia (BPH) is a common condition in aging men and may lead to lower urinary tract symptoms (LUTS), subvesical obstruction, and related complications such as urinary retention, bladder stones, recurrent infections, and renal impairment. Transurethral resection of the prostate (TURP) remains the standard surgical treatment for symptomatic benign prostatic obstruction (BPO). However, a subset of patients, particularly those with an underlying hypocontractile detrusor, may not benefit from TURP and continue to experience significant voiding dysfunction after surgery. Since formal urodynamic pressure-flow studies are invasive, time-consuming, and resource-intensive, there is clinical value in identifying non-invasive predictors of surgical success.
This prospective observational study will evaluate preoperative clinical, ultrasound, and uroflowmetry parameters associated with successful postoperative outcomes after TURP. Adult male patients with symptomatic BPH and an indication for TURP will undergo standardized assessment including medical history, IPSS questionnaire, digital rectal examination, serum PSA, ultrasound-determined prostate volume and post-void residual urine, and uroflowmetry parameters such as Qmax and voided volume. Comorbidities relevant to bladder function, including diabetes mellitus and neurological conditions, will be recorded. TURP will be performed according to standard clinical practice, and resected tissue will undergo routine histopathological evaluation.
Postoperative follow-up will include IPSS reassessment, uroflowmetry, and ultrasound measurement of residual urine at one month and during subsequent routine evaluations. Surgical outcomes will be categorized as successful or unsuccessful based on subjective symptom improvement and objective urinary flow parameters. Using the collected data, the study will identify which preoperative variables correlate with favorable postoperative outcomes. These parameters will subsequently be used to inform the development of a predictive TURP outcome calculator.
The anticipated value of this study is to support individualized clinical decision-making in patients with BPH, particularly those in whom the distinction between obstruction and impaired detrusor contractility is unclear. By identifying patients who are less likely to benefit from TURP based on non-invasive parameters, the resulting calculator may help reduce unnecessary procedures, avoid postoperative morbidity, and potentially limit the need for invasive urodynamic testing.
Первичные конечные точки
- Change in IPSS Score After TURP [Срок оценки: 1 Month, 3 Months]
- Change in Qmax After TURP [Срок оценки: 1 Month, 3 Months]
- Change in Post-Void Residual Urine (PVR) [Срок оценки: 1 Month, 3 Months]
- Change in Voided Volume on Uroflowmetry [Срок оценки: 1 Month, 3 Months]
Вторичные конечные точки (2)
- Composite Surgical Success Rate [Срок оценки: 1 Month, 3 Months]
- Complication Rate Following TURP [Срок оценки: 30 Days]
Критерии участия
Критерии включения
- Male patients aged 18 years or older
- Clinical diagnosis of benign prostatic hyperplasia (BPH)
- Indication for TURP based on symptoms or complications
- Completed preoperative evaluation (IPSS, ultrasound, PSA, uroflowmetry)
- Able to provide informed consent
Критерии исключения
- Suspected or confirmed prostate cancer
- No clinical evidence of BPH
- Prior urodynamic diagnosis of underactive/neurogenic bladder
- Prior prostate surgery
- Inability to participate in follow-up
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07277556 · KBSD-2025-03-3557 · KBSD-URO--2025