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.

Brief Title

Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

Official Title

InterStim Implantation Rates Following Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

Brief Summary

The investigators propose a randomized control trial comparing the rate of implantation of<br /> the InterStim device following Percutaneous Nerve Evaluation (PNE) performed with or without<br /> fluoroscopic guidance.

Detailed 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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.