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Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

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ClinicalTrials.gov Identifier: NCT02677753
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Sean Francis, University of Louisville

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Urinary Incontinence Fecal Incontinence Radiation: Fluoroscopy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: InterStim Implantation Rates Following Percutaneous Nerve Evaluation With Fluoroscopy Versus Without
Actual Study Start Date : August 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
Active Comparator: Fluoroscopy guided PNE
Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires.
Radiation: Fluoroscopy
No Intervention: PNE without fluoroscopic guidance
No fluoroscopy will be used during or after the placement of the lead wires.



Primary Outcome Measures :
  1. Implantation rate of InterStim following PNE with or without use of fluoroscopy [ Time Frame: 3 months ]
    Percentage of PNEs that have permanent neuromodulation device implanted by 3 months


Secondary Outcome Measures :
  1. Percent improvement in symptoms as determined by pre and post PNE voiding diaries [ Time Frame: 1-2 weeks ]
    Percentage improvement in symptoms on bladder diaries at follow up visit



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
Contact: Casey Kinman, MD 502-561-7260 casey.kinman@louisville.edu
Contact: Ankita S Gupta, MD, MPH 502-561-7260 ankita.gupta@louisville.edu

Locations
United States, Kentucky
University of Louisville Physicians Recruiting
Louisville, Kentucky, United States, 40205
Contact: Ankita Gupta, MD, MPH    502-588-7660      
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Sean L Francis, MD University of Louisville

Responsible Party: Sean Francis, Principal investigator, University of Louisville
ClinicalTrials.gov Identifier: NCT02677753     History of Changes
Other Study ID Numbers: 15.0034
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Fecal Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases