Идёт набор NCT04527445

Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement

Без фазы С лечением Radiation Exposure Overactive Bladder Urge Incontinence Urgency-frequency Syndrome

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: Reduced radiation fluoroscopy, Conventional fluoroscopy.
Кому может быть актуально: Состояния в реестре: Radiation Exposure, Overactive Bladder, Urge Incontinence, Urgency-frequency Syndrome. Базовые параметры: 18 лет — 89 лет · Все.
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 →

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Официальное название

Reduction in Fluoroscopy Radiation Exposure During Lead Implantation for Sacral Neuromodulation: A Randomized Prospective Study

Обзор

Fluoroscopy is performed when placing a lead during a sacral neuromodulation procedure. During lead placement, subjects will receive either conventional or experimental fluoroscopic settings. The radiation exposure will be compared between the two groups.

Подробное описание

Patients scheduled for lead implantation during sacral neuromodulation in the operating room and consent will be included in this study. Placement of the lead in the operating room with fluoroscopy is the standard of care in this procedure. Fluoroscopy is performed with a C-arm and there are settings that change the radiation exposure. Patients scheduled to undergo lead placement will be randomized to: a) the investigational (reduced radiation with fluoroscopic settings) or b. the control (conventional fluoroscopy).

The surgeon can change fluoroscopy radiation exposure by changing C-arm settings from the reduced radiation to conventional fluoroscopic options. During the surgery, the surgeon may change the settings from reduced radiation (intervention) to conventional fluoroscopy (control) to safely place lead. The surgeon will use their judgment to optimally place lead and maintain safety during placement. Any deviation from randomization will be recorded.

The intervention arm is defined: Reduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current.

The control arm is defined: The standard of care in the conventional fluoroscopy, the C-arm is set at 30 pulses-per-second and the current set at the default.

Вмешательства

Процедура Reduced radiation fluoroscopy
See previous information about each arm
Процедура Conventional fluoroscopy
See previous information about each arm

Первичные конечные точки

Radiation Exposure [Срок оценки: At time of procedure]

Вторичные конечные точки (5)

Optimal lead placement [Срок оценки: At time of procedure]
Voiding log (Bladder Record) [Срок оценки: 3 months after surgery]
Clinical Outcome assessed by validated questionnaire [Срок оценки: 3 months after surgery]
Inoperative complications [Срок оценки: At time of procedure]
Operative times [Срок оценки: At time of procedure]

Критерии участия

Критерии включения

Patients undergoing lead implantation for sacral neuromodulation that have overactive bladder as defined by urinary urgency, frequency, nocturia with or without urgency incontinence.