Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

NCT02677753 | Completed Results

• 1 other identifier: 15.0034
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder; Urinary Incontinence; Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Fluoroscopy guided PNE

ACTIVE COMPARATOR

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

Radiation: Fluoroscopy

PNE without fluoroscopic guidance

NO INTERVENTION

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

Interventions

Fluoroscopy RADIATION

Fluoroscopy guided PNE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients in whom bilateral leads cannot be placed
• Pregnant women
• Prisoners
• Less than 18 years of age

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville Physicians

Louisville, Kentucky, 40205, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence; Fecal Incontinence

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Sean Francis
• Organization: University of Louisville

sean.francis@louisville.edu

5025617260

Study Officials

• Sean L Francis, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 9, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: June 9, 2020
• Results First Posted: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)