Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02677753
Study type	Interventional
Source	University of Louisville
Contact
Status	Completed
Phase	N/A
Start date	April 2016
Completion date	April 2019

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