Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Radiation Exposure, Overactive Bladder, Urge Incontinence, Urgency-frequency Syndrome

Intervention / Treatment
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* Procedure: Reduced radiation fluoroscopy
* Procedure: Conventional fluoroscopy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reduced Radiation Fluoroscopy<br>Reduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current. | Procedure: Reduced radiation fluoroscopy<br>* See previous information about each arm<br>|
| Active Comparator: Conventional Fluoroscopy<br>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<br>* See previous information about each arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation Exposure | measure radiation exposure, milligray (mGy) | At time of procedure | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sacral Neuromodulation, Fluoroscopy