Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

Not Applicable

Completed

• Conditions: Overactive Bladder; Fecal Incontinence; Urinary Incontinence
• Interventions: Radiation: Fluoroscopy

• Registration Number: NCT02677753
• Lead Sponsor: University of Louisville

Brief 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.

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.

Study Timeline

• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-09
• Study Start: 2016-04
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Results First Submitted: 2020-05-13
• Status Verified: 2020-06
• Results First Submitted QC: 2020-06-07
• Last Update Submitted: 2020-06-07
• Results First Posted: 2020-06-09
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoroscopy guided PNE	Fluoroscopy	Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires.

Primary Outcome Measures

Name	Time	Method
Number of Participants With InterStim Implantation Following PNE With or Without Use of Fluoroscopy	3 months	Percentage of PNEs that have permanent neuromodulation device implanted by 3 months

Trial Locations

Locations (1)

University of Louisville Physicians; 🇺🇸 Louisville, Kentucky, United States