Percutaneous Nerve Evaluation With Fluoroscopy Versus Without
| Status: | Recruiting |
|---|---|
| Conditions: | Overactive Bladder, Gastrointestinal, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/27/2018 |
| Start Date: | August 2016 |
| End Date: | February 2019 |
| Contact: | Casey Kinman, MD |
| Email: | casey.kinman@louisville.edu |
| Phone: | 502-561-7260 |
InterStim Implantation Rates Following Percutaneous Nerve Evaluation With Fluoroscopy Versus Without
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.
the InterStim device following Percutaneous Nerve Evaluation (PNE) performed with or without
fluoroscopic guidance.
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.
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.
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
We found this trial at
1
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