Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

Urinary Incontinence Clinical Trial

Official title:

InterStim Implantation Rates Following Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02677753
• Other study ID #: 15.0034
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: April 2019

Study information

• Verified date: June 2020
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fecal Incontinence
• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Radiation:
• Fluoroscopy

Locations

Country	Name	City	State
United States	University of Louisville Physicians	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With InterStim Implantation Following PNE With or Without Use of Fluoroscopy	Percentage of PNEs that have permanent neuromodulation device implanted by 3 months	3 months