Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement

Not Applicable

Recruiting

• Conditions: Urge Incontinence; Radiation Exposure; Overactive Bladder; Urgency-frequency Syndrome
• Interventions: Procedure: Reduced radiation fluoroscopy; Procedure: Conventional fluoroscopy

• Registration Number: NCT04527445
• Lead Sponsor: Loma Linda University

Brief 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.

Study Timeline

• Study First Submitted: 2020-08-23
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Study Start: 2025-08
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

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

Exclusion Criteria

• neurogenic bladder, BMI >40, or peripheral neuropathy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reduced Radiation Fluoroscopy	Reduced radiation fluoroscopy	Reduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current.
Conventional Fluoroscopy	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.

Primary Outcome Measures

Name	Time	Method
Radiation Exposure	At time of procedure	measure radiation exposure, milligray (mGy)

Secondary Outcome Measures

Name	Time	Method
Clinical Outcome assessed by validated questionnaire	3 months after surgery
Inoperative complications	At time of procedure	surgery complication
Optimal lead placement	At time of procedure	based on intraoperative motor response
Voiding log (Bladder Record)	3 months after surgery	Clinical Outcome
Operative times	At time of procedure	minutes

Trial Locations

Locations (1)

Loma Linda University Health; 🇺🇸 Loma Linda, California, United States