Reduction in Fluoroscopy Radiation Exposure During Lead Implantation for Sacral Neuromodulation: A Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Radiation Exposure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Subjects notified of the arm after the procedure is performed
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing lead implantation for sacral neuromodulation that have overactive bladder as defined by urinary urgency, frequency, nocturia with or without urgency incontinence.
排除标准
- •neurogenic bladder, BMI >40, or peripheral neuropathy.
研究组 & 干预措施
Reduced Radiation Fluoroscopy
Reduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current.
干预措施: Reduced radiation fluoroscopy (Procedure)
Conventional Fluoroscopy
The standard of care is the conventional fluoroscopy, the C-arm is set at 30 pulses-per-second and the current set as the default.
干预措施: Conventional fluoroscopy (Procedure)
结局指标
主要结局
Radiation Exposure
时间窗: At time of procedure
measure radiation exposure, milligray (mGy)
次要结局
- Optimal lead placement(At time of procedure)
- Voiding log (Bladder Record)(3 months after surgery)
- Clinical Outcome assessed by validated questionnaire(3 months after surgery)
- Inoperative complications(At time of procedure)
- Operative times(At time of procedure)