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Completed

NCT Number: NCT02677753

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoroscopy

Radiation

Primary outcomes

  1. Number of Participants With InterStim Implantation Following PNE With or Without Use of Fluoroscopy

    Time frame: 3 months

    Percentage of PNEs that have permanent neuromodulation device implanted by 3 months

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

InterStim Implantation Rates Following Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 9, 2016
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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