Percutaneous Nerve Evaluation With Fluoroscopy Versus Without
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|ClinicalTrials.gov Identifier: NCT02677753|
Recruitment Status : Enrolling by invitation
First Posted : February 9, 2016
Last Update Posted : April 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder Urinary Incontinence Fecal Incontinence||Radiation: Fluoroscopy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||InterStim Implantation Rates Following Percutaneous Nerve Evaluation With Fluoroscopy Versus Without|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Fluoroscopy guided PNE
Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires.
No Intervention: PNE without fluoroscopic guidance
No fluoroscopy will be used during or after the placement of the lead wires.
- Implantation rate of InterStim following PNE with or without use of fluoroscopy [ Time Frame: 6 months ]
- Percent improvement in symptoms as determined by pre and post PNE voiding diaries [ Time Frame: 2 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02677753
|Principal Investigator:||Sean L Francis, MD||University of Louisville|