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Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

Primary Purpose

Overactive Bladder, Urinary Incontinence, Fecal Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluoroscopy
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Louisville Physicians

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Fluoroscopy guided PNE

PNE without fluoroscopic guidance

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 4, 2016
Last Updated
June 7, 2020
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT02677753
Brief Title
Percutaneous Nerve Evaluation With Fluoroscopy Versus Without
Official Title
InterStim Implantation Rates Following Percutaneous Nerve Evaluation With Fluoroscopy Versus Without
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urinary Incontinence, Fecal Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluoroscopy guided PNE
Arm Type
Active Comparator
Arm Description
Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires.
Arm Title
PNE without fluoroscopic guidance
Arm Type
No Intervention
Arm Description
No fluoroscopy will be used during or after the placement of the lead wires.
Intervention Type
Radiation
Intervention Name(s)
Fluoroscopy
Primary Outcome Measure Information:
Title
Number of Participants With InterStim Implantation Following PNE With or Without Use of Fluoroscopy
Description
Percentage of PNEs that have permanent neuromodulation device implanted by 3 months
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean L Francis, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville Physicians
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Age Race BMI Preoperative diagnosis Previous treatments for urinary urgency, frequency, retention, and/or urinary or fecal incontinence Percent improvement in symptoms as determined by pre and post PNE voiding diaries Whether or not InterStim implanted within 3 months of PNE Date of PNE

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Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

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