Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

Study Overview
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Brief Summary
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The investigators propose a randomized control trial comparing the rate of implantation of the InterStim device following Percutaneous Nerve Evaluation (PNE) performed with or without fluoroscopic guidance.

Detailed Description
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Sacral nerve stimulation (SNS) is a well-established treatment for refractory urinary urgency, frequency, retention and urge incontinence as well as fecal incontinence. Patients whose symptoms are refractory to more conservative therapies such as behavioral modification and/or medications are candidates for SNS. The InterStim system consists of a permanent tined lead and implantable pulse generator (IPG) or battery that delivers the sacral neuromodulation. This device is typically implanted after patients have a successful response to a trial of sacral neuromodulation with a temporary lead and external battery. The temporary lead placement is known as a Percutaneous Nerve Evaluation (PNE) and is typically done in as an outpatient procedure using local anesthetic. It is standard practice to use fluoroscopy intraoperatively to confirm correct placement of the permanent lead. Additionally, some physicians also use fluoroscopy to confirm correct placement of temporary lead during PNE while others place the lead based on anatomical landmarks and expected elicited responses for S3 stimulation. The investigators propose a randomized control trial comparing the rate of implantation of the InterStim device following (PNE) performed with or without fluoroscopic guidance.

Official Title
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InterStim Implantation Rates Following Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

Conditions
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Urinary Incontinence, Overactive Bladder, Fecal Incontinence

Intervention / Treatment
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* Radiation: Fluoroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women age >18 English speakers Patients with urinary urgency, frequency, or urge incontinence refractory to at least 1 other intervention who elect to undergo PNE Exclusion Criteria: Patients in whom bilateral leads cannot be placed Pregnant women Prisoners Less than 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: Fluoroscopy guided PNE<br>Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires. | Radiation: Fluoroscopy<br> <br> |
| No Intervention: PNE without fluoroscopic guidance<br>No fluoroscopy will be used during or after the placement of the lead wires. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With InterStim Implantation Following PNE With or Without Use of Fluoroscopy | Percentage of PNEs that have permanent neuromodulation device implanted by 3 months | 3 months |