NCT04527445

Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Radiation Exposure
• Overactive Bladder
• Urge Incontinence
• Urgency-frequency Syndrome

Interventions

Type	Name	Description
PROCEDURE	Reduced radiation fluoroscopy	See previous information about each arm
PROCEDURE	Conventional fluoroscopy	See previous information about each arm

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2020-08-26
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States