Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

NCT ID: NCT02677753

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-04-30

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.

Conditions

Overactive Bladder; Urinary Incontinence; Fecal Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluoroscopy guided PNE

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

Group Type: ACTIVE_COMPARATOR

Fluoroscopy

Intervention Type: RADIATION

PNE without fluoroscopic guidance

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fluoroscopy

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Sean Francis

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sean L Francis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville Physicians

Louisville, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15.0034

Identifier Type: -

Identifier Source: org_study_id