Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

University of Louisville (UOFL)

Status: Completed

Conditions: Fecal Incontinence; Urinary Incontinence; Overactive Bladder

Treatments: Radiation: Fluoroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02677753

15.0034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Fluoroscopy guided PNE

Active Comparator group

Description:

Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires.

Treatment:

Radiation: Fluoroscopy

PNE without fluoroscopic guidance

No Intervention group

Description:

No fluoroscopy will be used during or after the placement of the lead wires.