An interventional study of Reduced radiation fluoroscopy and Conventional fluoroscopy in Radiation Exposure, Overactive Bladder and Urge Incontinence, sponsored by Loma Linda University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Loma Linda University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Reduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current.
Procedure: Reduced radiation 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.
Procedure: Conventional fluoroscopy
See previous information about each arm
See previous information about each arm
Radiation Exposure
measure radiation exposure, milligray (mGy)
Time frame: At time of procedure
Optimal lead placement
based on intraoperative motor response
Time frame: At time of procedure
Voiding log (Bladder Record)
Clinical Outcome
Time frame: 3 months after surgery
Clinical Outcome assessed by validated questionnaire
Time frame: 3 months after surgery
Inoperative complications
surgery complication
Time frame: At time of procedure
Operative times
minutes
Time frame: At time of procedure
Plan to share: No
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